Amgen Jobshttp://www.amgen.jobs2012-05-27 00:49:24.701615USAThousand OaksAuto req 13782BR Job Posting Title Legal Coordinator Career Category Law/Legal Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The candidate will support attorneys in the Development & Regulatory Law Group. Responsibilities will include managing multiple and/or complex calendars and will involve prioritizing schedules, coordinating travel arrangements, answering phones and making proper referrals; setting up high-level meetings, preparing expense reports, maintaining files, and providing back-up administrative support when the Sr Legal Executive Assistant is out of office as required. Basic Qualifications Associate’s degree & 2 years of directly related experience OR High school diploma / GED & 4 years of directly related experience Preferred Qualifications Associates degree 5+ years of related experience in legal and administrative functions in support of legal staff Prior law firm or in-house law department experience Outlook, Word, PowerPoint and Excel experience including presentation design and spreadsheet skills Must possess executive level skills and the ability to interface with internal and external contacts. The ability to deal with sensitive and confidential information with diplomacy and discretion is required, as well as a high degree of accuracy and attention to detail. Ability to work in teams is a must. Ability to multi-task and prioritize work is essential.2012-05-24 19:05:43United StatesAmgenCalifornia13782BRCAThousand Oaks, CA28931938http://www.amgen.jobs/xml/28931938/jobPTRJuncosAuto req 15675BR Job Posting Title Principal Scientist Career Category Process Development Employee Subgroup Salaried FT Country (State/Region) United States - Puerto Rico Location (City) Juncos Amgen Job Description SUMMARY To develop projects/programs and contribute to novel experimental strategies and scientific vision. Functions as a lead scientific resource with cross-functional impact. Capable of managing and leading scientific projects which may involve cross functional areas FUNCTIONS 1. Guides the successful completion of major programs by either functioning in a project leadership role or as the lead scientific/technical resource. 2. Decisions or recommendations impact the ability to achieve functional /departmental objectives. 3. Provides guidance in the resolution of scientific/technical issues within the function/department. 4. Works independently and integrates activities with other function/department. 5. Exercises considerable latitude in determining objectives or assignments within the function /department 6. Evaluates progress toward goals and achievement of milestones for work group, with limited additional oversight, may translate evaluation into appropriate action. 7. Anticipates complex technical problems and develops practical an innovative solutions. 8. Frequently develops novel processes or approaches to solve problems within a broad discipline within the work group. 9. Identifies and analyzes factors and trends outside immediate area that impact project or function/department 10. Frequently introduces or creates new technologies and concepts 11. Leads teams that contribute to the achievement of department/project/product team objectives 12. Coaches, motivates and provides career and scientific/technical, advice to colleagues within the function/department 13. Communicates and/or presents scientific/technical information formally and informally within area of expertise to a diverse set of audiences, including senior management and external scientific community 14. Applies knowledge of drug discovery and development process to guide functions/departments 15. Act as scientific/technical expert within the function /department 16. Leads the development of key scientific/technical comments. ** Other functions may be assigned. Basic Qualifications Doctorate degree and 2 years of directly related experience or Master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience or Associate’s degree and 10 years of directly related experience. Preferred Qualifications COMPETENCIES/SKILLS ? Working knowledge of pharmaceutical/biotech processes ? Familiarity with documentation in a highly regulated environment ? Ability to operate specialized laboratory equipment and computers as appropriate. ? Ability to interpret and apply GLPs and GMPs. ? Able to develop solutions to routine technical problems of limited scope ? Demonstrated skills in the following areas: o Problem solving and applied engineering. o Basic technical report writing o Verbal communication ? Demonstrated Skills in the following areas: o Basic technical presentations o Personal Organization o Dealing with and managing change o Technical (Equipment Specific) o Analytical Problem Solving o Computer Literacy ? Specialized equipment/process expertise ? Interacts effectively with variety of communication and working styles ? Ability to independently determine when additional internal resources are required to solve problems ? Ability to handle multiple projects at one time ? Demonstrated Skills in the following areas: o Schedule development o Facilitation o Collaboration o Completion and follow-up ? Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope ? Problem solving skills requiring the application of scientific and theory and calculations and creative skills in the development of hypotheses and approach ? Working knowledge of financial analysis tools ? Ability to delegate and manage the project work of others ? Demonstrated Skills in the following areas: o Negotiation, persuasion and facilitation o Collaboration o Project cost development o Conflict Resolution o Leadership and teambuilding ? Management of contractors and vendors ? Knowledge of theories and principles related to leading edge technologies. ? Advanced (industry level) technical expert in at least one specialty area. ? Ability to motivate and communicate visions/missions ? Demonstrated Skills in the following areas: o Advanced project management o Presentations to large groups o External networking ? Personnel coaching and development Other preferred qualifications: 1) Guides the successful completion of major programs by either functioning in a project leadership role or as the lead scientific/technical resource. 2) Decisions or recommendations impact the ability to achieve functional /departmental objectives. 3) Frequently develops novel processes or approaches to solve problems within a broad discipline within the work group. 4) Coaches, motivates and provides career and scientific/technical, advice to colleagues within the function/department 5) Demonstrated Skills in the following areas: o Schedule development o Facilitation o Collaboration o Completion and follow-up 6) Demonstrated Skills in the following areas: o Negotiation, persuasion and facilitation o Collaboration o Project cost development o Conflict Resolution o Leadership and teambuilding 7) Personnel coaching and development.2012-05-24 19:03:47Puerto RicoAmgenNone15675BRNoneJuncos, PTR28931880http://www.amgen.jobs/xml/28931880/jobUSAThousand OaksAuto req 15795BR Job Posting Title Marketing and Commercial Development Director Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This is a leadership role shaping the long term strategic direction and reputation of Amgen’s Japan and Asia Pacific (JAPAC) Region, and the role has a reporting relationship to the Regional Vice President/ Japan, Asia, Middle East, Africa and Russia. Deep and recent understanding of China and Japan market would be a significant advantage. The role is responsible for managing strategic and commercial elements of the JAPAC Region. Strategy & Ops responsibilities include: •Leads development of Regional Strategic Plan and ensure delivery of regional strategies •Work with Region and other functions, e.g., BAI, GVA, to generate deep insights into Regional needs •Work with Region and other functions, e.g., Global Marketing, to generate pipeline forecasts •Provide commercial assessment of business development opportunities •Working with the Region and Finance to manage the Regional P&L •Delivers the cross functional work plan for the China entry and launch of Amgen’s products. •Develop reports and communications to provide visibility to JAPAC deliverables status to Corporate and internal customers •Develop and maintain relationships with external consultants and regional experts Skills & Experience Utilized in the role •Foreign language skills a plus – Japanese, Mandarin •Maintaining an entrepreneurial spirit by making fast, robust and cost-effective decisions •Problem Solving and creativity •Forecasting •Leading & collaborating across the matrix to deliver results Basic Qualifications •Doctorate degree & 4 years of directly related experience OR •Master’s degree & 8 years of directly related years OR •Bachelor’s degree & 10 years of directly related experience Preferred Qualifications •MBA or other graduate degree preferred. •Consulting background is beneficial •8 + years of pharmaceutical and/or biotech leadership experience •Understanding of Asia Pacific regional requirements •Excellent understanding of Amgen organization and culture – can navigate the company •Ability to lead cross-functional teams and projects •Track record of producing results and executing under tight deadlines •Comfortable with ambiguity •Ability to prioritize and resolve business issues •Ability to manage and communicate with senior stakeholders •Flexible, embraces new professional experiences •Highly developed analytical skills •Experience planning and executing new product launches2012-05-24 19:03:31United StatesAmgenCalifornia15795BRCAThousand Oaks, CA28931873http://www.amgen.jobs/xml/28931873/jobCANNoneAuto req 15811BR Job Posting Title Senior Associate, Supply Chain Career Category Supply Chain Employee Subgroup Salaried FT Country (State/Region) Canada Location (City) Mississauga Amgen Job Description Position: Senior Associate, Supply Chain Reports to: Supply Chain Senior Manager Grade Level: 4 Starting: June 2012 Location: Mississauga, ON (Head Office) Internal applicants are required to have a discussion with their current manager regarding intent to apply. Job Description: General Accountability - Planning & scheduling of commercial goods in Canada in order to achieve seamless service to patients. Administer and manage local commercial inventories working together with our distribution group and 3rd party logistics providers. SAP Lead for item master inputs & metrics reporting. Strong collaboration with local & corporate groups in order to achieve these accountabilities. Specific Responsibilities - Work with Supply Chain Senior Manager to manage local forecast planning, product supply planning and inventory / scrap planning. Maintain every patient-every-time performance. - Prepare monthly product supply files with actual, LE, & budget data. Work with Finance partner on validating planning inputs within Global system. Liaise with Finance on implementing enhanced forecasting techniques to manage submission deadlines to Corporate. - Modeling demand variability: Perform regular and ad-hoc depletion simulations, aging analysis and scrap scenarios for existing products & new launches. - Performance metrics: Develop and manage performance dashboards to report on SKU Splits tracking, New Product Launches, Forecast Accuracy, & Inventory / Scrap value. - Work with distribution group in optimizing inventory plan of Canadian distribution centers. - Work with analytics group on forecast scenarios & reporting for commercial products. - Active participation in Consensus Forecast & Forecast accuracy meetings. - Active participation in Global Inventory meetings to support SAP master data accuracy initiatives. - ERP: Responsible for SAP item master inputs & validation to support existing products & new product launches. - APO: Responsible for monthly planning inputs in APO aligned with Corporate planning cycles. Basic Qualifications Selection Criteria: - 3 to 5 years supply chain experience (pharmaceutical industry preferred) - Bachelor’s degree – B.A. or B.Sc. - Experience in SAP (Plan to Stock module specifically), APO experience would be an asset or similar enterprise planning systems experience - Strong analytical & problem solving skills, Solutions mindset, strong attention to detail - Expertise in Microsoft office applications (Excel, Word, Powerpoint), Microsoft Project would be an asset - Strong interpersonal & written communications skills - High achiever with a keen interest in Supply Chain2012-05-24 19:02:47CanadaAmgenNone15811BRNoneVirtual, CAN28931861http://www.amgen.jobs/xml/28931861/jobUSAThousand OaksAuto req 8413BR Job Posting Title Category Sr Mgr Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Senior Category Manager is responsible for managing the overall sourcing and supplier management process for respective category. The individual is responsible for the category management process: leading the industry analysis to identify leading suppliers and specific industry characteristics; conducting client requirement analysis; developing a cost-effective comprehensive category strategy based on customer and industry analyses; developing global supply plans and developing contracts with new suppliers or renegotiating existing contracts. The Senior Category Manager is responsible for establishing and implementing a sustaining Supplier Relationship Management process with suppliers and internal business partners. In addition to strategy development and SRM, the individual will also execute sourcing and supplier selection processes across several Operations related categories. The successful candidate will develop close relationships with both suppliers and business partner groups. The Senior Category Manager may supervise one or more staff. Basic Qualifications Doctorate degree & 2 years of directly related experience OR -Master’s degree & 6 years of directly related experience OR -Bachelor’s degree & 8 years of directly related experience OR -Associate’s degree & 10 years of directly related experience OR -High school diploma / GED & 12 years of directly related experience Preferred Qualifications Preferred 8+ years of experience (including 3-5 years experience with pharmaceutical/biotech preferred) and 3-5 year's strategic sourcing/category management experience. •MBA preferred. •The successful candidate should have excellent organizational, project management, communication (written and verbal), in-depth supplier/industry analysis knowledge, expertise in supplier and contracts negotiation and extensive knowledge of category management practices and principles. •Candidates must possess strong interpersonal skills, financial skills, a high level of client focus and the ability to effectively interface with all levels of management, including executive management. •In addition, candidates should have significant experience in leading cross-functional teams, conflict resolution and stakeholder management. Category experience in one or more areas: Capital Construction, Manufacturing Equipment, Facilities management services or Direct Materials2012-05-24 19:02:24United StatesAmgenCalifornia8413BRCAThousand Oaks, CA28931855http://www.amgen.jobs/xml/28931855/jobUSAThousand OaksAuto req 15737BR Job Posting Title Finance Sr Manager -- IT Vendor Management Office Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role reports into the lead of the Vendor Management Office VMO Lead, is an integral part of the overall Service Management and Governance (SM&G) team, and a resource for team members for pricing, new work, extensions of scope, and other financial analysis. The Finance Sr Manager is accountable for assuring the accuracy and audit ability of all financial transactions related to the outsourced IT environment, and to make certain the proper financial controls are in place for the term of the agreement. This role is responsible for establishing and coordinating all SM&G organization budgets and reviews of business cases for business unit IT projects to ensure financial viability. The Finance Sr Manager is accountable to ensure accuracy of all Service Provider charges, retained expenses and pass-through expenses. The Finance Sr Manager is responsible for providing regular IT financial reporting, including budgeted vs. actual expenses, forecasts, and financial trend analysis. The Finance Sr Manager is also responsible for ensuring that the appropriate investigation and validation processes are established to handle financial variances in forecasted expenses or usage. The Finance Sr Manager will also work with other SM&G team members and lead or participate in such activities as: contract negotiations, vendor reviews, special projects, benchmarks and audits, root cause analysis and other assignments as needed. This position works closely with the Contract Management Sr Manager, Contract Executive, other IT organizations and key Service Providers to ensure overall operational excellence and customer satisfaction. Provides direction and leadership to ensure that proper financial controls are in place for the term of the contract. - Establishes and maintains consistent methodologies for performing financial business reviews on effectiveness of the Service Provider relationship - Ensures compliance with GAAP and Client’s internal accounting policies - Ensure compliance with tax laws - Ensure SOX control framework implemented and continuously reviewed if applicable - Ensure Service Provider implementation of required SOX controls if applicable Develops, administers, controls and optimizes total cost of sourcing in line with the business and sourcing targets: - Plans and manages budget/ forecast - Investigates and resolves variances in forecasted expenses or usage - Manages variance in planned expenses or resource usage - Controls global sourcing budget and manages financial data and reporting - Manages any global special project budget in conjunction with the Sourcing Executive Ensures accuracy of all contract-related charges - Monitors and audits all monthly charges to ensure accuracy of Service Provider charges, Client-retained expenses, and pass-through expenses - Investigates and resolves discrepancies Ensures timely payment of Service Provider invoices - Establishes and maintains the charge-back process and system - Ensures timely and accurate payment of Service Provider invoices - In conjunction with the Service Management & Governance Executive and Contract Manager, ensures identification and collection/payment of any performance credits or other sums due/payable - Manages and controls the financial implications of contractual obligations Provides direction and support in the financial aspects of contract negotiations - Ensures overall effectiveness of the financial side outsourcing efforts - Serves as the liaison between outsourcing organization and other corporate entities on finance-related outsourcing issues - sures compliance with corporate policies and reporting requirements Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree or & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelor Degree in Accounting/Finance Eight years of financial accounting experience MBA/CPA certification Thorough understanding of Outsourcing Services Agreements, Financial Analysis, Cost Accounting, Cost Models, Cost Allocation processes, and Economics Understanding of IT services such as computer/infrastructure services and telecommunications services; pricing models, and resource units (measures of service utilization) Financial and Process skills; an understanding of the company's financial practices and goals – including drivers of process costs, ability to work with supplier to ensure effective cost solutions and agreed upon service level agreements Knowledge of Business Unit’s business environment, service requirements and culture Demonstrated ability to manage a large budget and exercise fiscal responsibility Demonstrated ability to assess needs, creatively approach solutions, decide and influence appropriate courses of action. Strong persuasion and problem resolution skills Service provider/vendor management experience Strong verbal and written communication skills with the ability to articulate complex ideas in easy to understand business terms to senior leaders Strong collaboration and partnering skills Working knowledge of applicable Sarbanes-Oxley regulations Working knowledge of any other biopharmaceutical industry2012-05-23 18:45:31United StatesAmgenCalifornia15737BRCAThousand Oaks, CA28892005http://www.amgen.jobs/xml/28892005/jobGBRCambridgeAuto req 15797BR Job Posting Title Associate Finance Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Field Based Uxbridge Amgen Job Description This role provides regular and ad-hoc financial, accounting, and analytical support. Responsibilities may include supporting various levels of Finance Managers and Revenue and Expense Analysts on tasks such as the monthly close, monthly forecasting, and ad-hoc projects related to our overall business. Additional responsibilities may include financial modeling, analysis of Finance spending, preparation and presentation of financial materials, variance analysis and special projects. Basic Qualifications Associate’s degree & 4 years of experience directly related to the job OR High school diploma / GED & 6 years of experience directly related to the job Preferred Qualifications • Strong communication skills • Excellent organizational skills and detail oriented • Ability to use Microsoft Word, Excel, and Power Point • Able to multi-task and stay focused on priorities in a fast paced environment to meet deadlines • Strong team player who is able to collaborate with colleagues on complex tasks • Prior work experience a plus • Biotechnology, pharmaceutical or healthcare industry experience is a plus but not required2012-05-23 18:45:28United KingdomAmgenNone15797BRNoneCambridge, GBR28892002http://www.amgen.jobs/xml/28892002/jobSWEStockholmAuto req 15747BR Job Posting Title Sr Associate BAI Career Category Sales & Marketing Operations Employee Subgroup Salaried FT Country (State/Region) Sweden Location (City) Stockholm Amgen Job Description As a member of the BPA team, Ensure technical sustainability for Sales Reporting Support and ensure utilization and adherence of the N&B DWS model , local cubes and dashboards Ensure uniform standards and consistency in N&B Sales models . Support and operational implementation of approved models or tools in N&B Region As a member of the Sales Force Effectiveness team Support to Activity reporting , target setting and SIP reporting Support and ensure utilization and adherence of the N&B Activity, Target setting and SIP models Ensure uniform standards and consistency in N&B SFE models . As a member of the SME team Enhance and develop other N&B SME models Support and enhance any system requirements. Processes and analyzes internal and external data sources. Coordinates with IS/COE to implement systems and processes initiated on both a European, Regional and an affiliate level. Support maximization and utilization of the available primary and secondary data sources/systems in support of audience/product. Any ad-hoc analysis required Basic Qualifications Minimum requirements - Academic education or experience from similar positions - Demonstrated excellence in Excel and data bases management - Technically excellent in analytical disciplines - Technically excellent in Excel and data management and analytical tools. - Experience in the Pharmaceutical industry Experience in project management Knowledge of the pharmaceutical business - Project/project manager of new models development - Experience of system support and development in cross-functional environments - Fluency in English, both in oral and written communication Preferred Qualifications - Experience as consultant/advisor - Experience of N&B co-operation - Experience of working with advance Excel and tools/models/ systems development - University Degree (data and/or engineering) - >2 year Industry/pharmaceutical knowledge - Analytical and Technical skills to develop tools, models and analysis for business and management, and be able to continually evaluate and improve our current tools - Knowledge and ability to work well with Excel, data bases in system interfaces - Strong numerical skills and creative problem solver - Ability to champion ideas and projects - Good Interpersonal skills to interact with internal customers - Leadership skills with knowledge and ability to work well within a matrix environment and teams - Project management skills - planning, prioritization, meeting management, project management and plan execution - Communication skills with an ability to efficiently and productively communicate both orally and in writing at all levels - Demonstrates behavior consistent with Amgen’s Values - Business professional with capacity to grow and learn, self aware, emotionally intelligent2012-05-23 18:45:01SwedenAmgenNone15747BRNoneStockholm, SWE28891992http://www.amgen.jobs/xml/28891992/jobUSAThousand OaksAuto req 15742BR Job Posting Title Contract Management Sr Manager -- IT Vendor Management Office Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role reports into the Vendor Management Office Lead, works with the Various IS Operational leads and the Governance Services Team and is ultimately responsible for a contract or given set of contracts. This person acts as the one escalation point for any issues related to the contract(s) they are assigned. In addition this person is responsible for the overall relationship and performance of the Service Providers. The Contract Management Sr Manager is accountable for managing all aspects of the client’s contractual agreement(s) with the Service Provider on behalf of the client and client business units. The Contract Principal works in close collaboration with Governance Services (ISG), Legal, ISGS, Service Delivery and Finance to: maintain a thorough knowledge of all aspects of the contract; modify the contract as needed; educate client leadership on the client’s and the Service Provider’s obligations within the overall agreement; report on the status of these obligations; manage issues related to the contract; and assist in interpreting the contract as needed. The Contract Principal will also work with ISG on negotiating amendments to the Contract. In cases where contract terms are in dispute between the client and the Service Provider, this role is the subject matter expert advocate for the client. The Contract Management Sr Manager: Manages overall compliance with contractual terms & conditions with the support of ISG: - Develop tools to support the Service Delivery and Governance teams, specifically the Deliverables & Obligations trackers, and refresh these as the contract evolves over time - Develops a Deliverables & Obligations Tracker, establishes a process for D&O tracking, assigns D&O responsibilities and manages the client and Service Provider compliance with obligations on an ongoing basis - Monitor and maintain the Service Provider and Client’s compliance with contract terms and conditions, commitments and notifications - Manages the end-to-end Supplier Audit process; ensures that appropriate audit controls are in place for Service Provider’s processes and invoices, in accordance with the process established in the Client’s Policy & Procedures Manual - Potentially manages Service Provider exit Guards the relationship with the Service Provider with support of ISG: - "Guards and owns the integrity of the pricing schedules and mechanisms and ensure they are fit for purpose" - Evaluate Performance Credits and approve any action plans resulting from critical service performance failures - Manages any re-pricing making use of existing contractual mechanisms for cost/price change Is responsible for contract maintenance with the support of ISG: - Manages the end-to-end lifecycle process of Contract Change from development through to execution, including obtaining the relevant stakeholder approvals; - Initiation + preparation of change request - Impact assessment and prioritization - Final approval - Physical update of contract - Evaluates innovation gain sharing mechanisms, and assures their alignment with the agreed-upon principles of innovation Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree or & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelor’s plus Eight years developing and managing contracts, procurement or other sourcing experience Understanding of IT services such as computer/infrastructure services and telecommunications services Extensive experience with negotiation with third parties Excellent verbal and written communication skills – with various levels of organization Change management and facilitation skills Proven ability to manage the development, implementation and ensure adherence to processes People management and collaboration skills Firm but fair mindset Working knowledge of any other biopharmaceutical industry2012-05-23 18:44:37United StatesAmgenCalifornia15742BRCAThousand Oaks, CA28891970http://www.amgen.jobs/xml/28891970/jobUSAThousand OaksAuto req 15785BR Job Posting Title Scientific Director - Comparative Biology & Safety Sciences Career Category Preclinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen is seeking an experienced drug development scientist to provide leadership and mentorship to the department and actively contribute in the drug development process from target selection and lead optimization through product registration. Working in a collaborative team environment with other colleagues in Research and Translational Sciences (e.g. therapeutic area scientists, drug metabolism, chemistry, protein sciences, early clinical development), the incumbent will contribute to the selection and safety assessment of small molecule and biologic therapeutics and represent Comparative Biology & Safety Sciences (CBSS) on drug development teams within Amgen. Amgen scientists make significant contributions, work in multiple therapeutic areas, and mentor and motivate their colleagues. As a Scientific Director in CBSS, you will design, implement, analyze and integrate a wide range of datasets from investigative studies and nonclinical safety assessment programs in support of drug discovery, lead optimization and drug development. Experience in resolving nonclinical safety issues through the establishment of novel protocols to solve experimental questions, in addition to devising strategies and planning activities to achieve project goals is required. An understanding of cutting-edge science and technology employed to enhance investigation of drug development safety liabilities is needed. You will participate and contribute to key project teams and provide regular updates as appropriate to senior management. You will be asked to mentor other colleagues and to contribute your expertise in the peer-review of plans and work products emerging from the department. Opportunities exist to serve as a leader for cross-functional CBSS teams focused on new initiatives, in-licensing, and emerging strategies. Basic Qualifications Doctorate degree & 7 years of directly related experience OR Master’s degree & 13 years of directly related experience OR Bachelor’s degree & 15 years of directly related experience Preferred Qualifications A D.V.M., M.D. and/or a Ph.D in a biological science with expertise in a specific disease discipline, comparative medicine or pathology highly preferred. A minimum of a combined 10 years experience of academic and industry experience in nonclinical drug development demonstrating a sustained record of achievement. Experience is needed to critically evaluate and interpret integrated sets of data from scientific experiments and then translate the potential clinical impact. Excellent verbal and written communication skills are necessary as the incumbent will contribute to appropriate sections of regulatory documents. Additional abilities expected include managing conflict, prioritization skills, resilience, and the demonstration of leadership through proactivity and influence, especially in a team environment. Post-doctoral research experience in toxicology, pathology or a disease specialty area. Board certification in toxicology or pathology. The preferred candidate will also have a working knowledge of computational and database tools for assessing multi-dimensional data and an ability to effectively query the literature and other public domain data repositories. The ability to work independently and to build productive cross-functional collaborations both internally and externally is also preferred.2012-05-23 18:44:03United StatesAmgenCalifornia15785BRCAThousand Oaks, CA28891955http://www.amgen.jobs/xml/28891955/jobUSAThousand OaksAuto req 15768BR Job Posting Title Sr Project Mgr Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Job Summary The Sr. Project Manager provides project management support & leadership to PST sub-teams, sub-team projects and subprojects and is accountable to the Global Project Manager, Product Strategy Team & / or Research team leaders, and his/her functional line Supervisor. The Sr. Project Manager must apply project management best practices in the development, initiation, planning, execution, control & closing of projects. Key Responsibilities - Team Leadership- Provide operational leadership in team and/or sub-team meetings and identify cross-functional implications, risks and issues. Elevate sub-team issues and work to overcome implementation obstacles at the functional level. Ensure strategic alignment between sub-teams and PST / Research project teams. Drive effective sub-team operations, including goal setting, sub-team charters, functional mgmt reviews, etc. and ensure that all goals and objectives are well understood by the various functional areas. - Cross Functional Communication- Provide timely, accurate communication between teams / sub-teams and functional departments. Communicate appropriate information on functional team status & issues to stakeholders. - Strategic Thinking - Actively participate in all PST sub-team team discussions and ensure all views are heard. Assist teams and sub-team leaders in the development of plans, appropriate updates to plans, and management of the process to ensure Governance Board review and approval of changes to plan. Coordinate with the teams and the sub-teams to ensure sub-team plan alignment with the Project strategic plans. - Risk Management- Conduct functional team-level risk assessment and scenario planning to support sub-team issues. Proactively drive development of contingency and/or risk-mitigation plans at the sub-team level. - Resource Planning- Provide information to assist with resource planning at the sub-team level and elevate resource issues as needed. Identify and reconcile resource issues across sites or functions that may impact global coordination. - Project Management Process- Manage all aspects of projects/processes: planning, estimating, sequencing and scheduling, monitoring and controlling, risk management, execution, and closing. Maintain a master project plan and schedule for assigned projects. Translate sub-team plans into actionable and measurable tasks. Follow up on action items from sub-team meetings. Establish and achieve project standards for work quality and quantity. - Product Team Deliverables- Ensure adherence to Commercialization and governance processes at the sub-team level. Assist in the development/update of key Commercialization sub-team deliverables, e.g., sub-team plans, etc. Generate periodic updates and/or prepare formal presentations to line managers and/or others for all management reporting. Provide detailed data support for portfolio management/DA processes. Drive the development of functional plans, update plans appropriately, and manage the process to ensure Governance Board review and approval of changes to plan Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree or & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - Project Management Professional(PMP) certification desired. - MBA or PhD - 7 or more years of experience in cross-functional clinical development project teams and/or experience with project management practice within the pharmaceutical industry - Experience working on Phase 3 or marketed product development2012-05-23 18:43:55United StatesAmgenCalifornia15768BRCAThousand Oaks, CA28891953http://www.amgen.jobs/xml/28891953/jobNLDBredaAuto req 15730BR Job Posting Title Sr Associate QA Career Category Quality Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Amgen Job Description Objective - To provide QA guidance and support in the production area at Amgen Breda - To perform batch record review of batches assembled, packaged and labeled and contract manufacturers. - To establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person Position Specific tasks: - Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions. - Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations. - Review and approve batch production record data entries before production activities take place - Perform finished product checks during (commercial) production runs - Compile and review batch records for lots assembled, packaged and labeled and contract manufacturers in preparation for disposition by Qualified Person. - Act as author for operational SOP’s and Work Instructions - Review of operational SOP’s and Work Instructions - Review and approve class I Non Conformances - Initiate and own QA Non Conformances as needed. In this job you work in 3 shifts (including night shifts) Basic Qualifications - MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience. - Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations. - Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases. - Manufacturing and/or Quality analytical processes and operations. - Fluent in English language. Preferred Qualifications - Fluent in Dutch language2012-05-22 19:48:28NetherlandsAmgenNone15730BRNoneBreda, NLD28868677http://www.amgen.jobs/xml/28868677/jobUSAThousand OaksAuto req 15752BR Job Posting Title Marketing Sr Mgr, Nephrology Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Manages the development and execution of marketing strategies and tactics for Aranesp® Nephrology and Aranesp® Oncology in the Hospital and Epogen®. This position uniquely partners across both the NBU and OBU. Responsibilities: 1. Leads cross-BU marketing for Aranesp in the Hospital (NBU and OBU). 2. Develops and executes the brand campaign, messages and tactical plans within a competitive environment (personal and non-personal). 3. Develops ESA-Nephrology patient resources. 4. Lead for congresses, commercial advisory boards and engagement with Nephrologists and Pharmacists. 5. Develops brand sales training programs and materials with Sales Training teams 6. Adapts brand tools and messages for use on digital platforms 7. Manages day-to-day operations of agency and vendors 8. Manages program budgets 9. Leads and coordinates market research for tools and programs with BAI 10. Develops metrics for program and tool effectiveness with BAI Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • MBA in business or masters in health sciences or additional education in biology, chemistry, life sciences • 2+ years in oncology or nephrology pharmaceutical / biotech hospital sales • 2+ years of pharmaceutical or biotech industry experience with focus on developing and/or executing market strategies and tactics • Knowledge of nephrology, oncology, cardiology, endocrinology, or related disease model desired • Successful track record of increasing responsibility within marketing or sales Competencies/Skills: • Strategic and tactical planning: demonstrated ability to analyze a business problem, develop an appropriate strategy, and implement effective tactics • Customer insights: ability to collaborate with internal and external groups and gain customer and patient insights • Brand Value • Commercial execution • Sales force engagement • Communication skills, written and oral • Matrix Management • Strong analytical and research skills • Project management: ability to set targets, track to milestones, and complete projects • Requires a thorough understanding of the legal and regulatory environment in pharmaceutical promotions and reimbursement.2012-05-22 19:48:19United StatesAmgenCalifornia15752BRCAThousand Oaks, CA28868665http://www.amgen.jobs/xml/28868665/jobUSAThousand OaksAuto req 15758BR Job Posting Title Sr Project Mgr - Product Strategy Team Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Job Summary The Sr. Project Manager provides project management support & leadership to PST sub-teams, sub-team projects and subprojects and is accountable to the Global Project Manager, Product Strategy Team & / or Research team leaders, and his/her functional line Supervisor. The Sr. Project Manager must apply project management best practices in the development, initiation, planning, execution, control & closing of projects. Key Responsibilities Team Leadership - Provide operational leadership in team and/or sub-team meetings and identify cross-functional implications, risks and issues. Elevate sub-team issues and work to overcome implementation obstacles at the functional level. Ensure strategic alignment between sub-teams and PST / Research project teams. Drive effective sub-team operations, including goal setting, sub-team charters, functional mgmt reviews, etc. and ensure that all goals and objectives are well understood by the various functional areas. Cross Functional Communication - Provide timely, accurate communication between teams / sub-teams and functional departments. Communicate appropriate information on functional team status & issues to stakeholders. Strategic Thinking - Actively participate in all PST sub-team discussions and ensure all views are heard and aligned. Assist teams and sub-team leaders in the development of plans, appropriate updates to plans, and management of the process to ensure Governance Board review and approval of changes to plan. Coordinate with the teams and the sub-teams to ensure sub-team plan alignment with the Project strategic plans. Risk Management - Conduct functional team-level risk assessment and scenario planning to support sub-team issues. Proactively drive development of contingency and/or risk-mitigation plans at the sub-team level. Resource Planning - Provide information to assist with resource planning at the sub-team level and elevate resource issues as needed. Identify and reconcile resource issues across sites or functions that may impact global coordination. Project Management Process - Manage all aspects of projects/processes: planning, estimating, sequencing and scheduling, monitoring and controlling, risk management, execution, and closing. Maintain a master project plan and schedule for assigned projects. Translate sub-team plans into actionable and measurable tasks. Follow up on action items from sub-team meetings. Establish and achieve project standards for work quality and quantity. Product Team Deliverables - Ensure adherence to Commercialization and governance processes at the sub-team level. Assist in the development/update of key Commercialization sub-team deliverables, e.g., sub-team plans, etc. Generate periodic updates and/or prepare formal presentations to line managers and/or others for all management reporting. Provide detailed data support for portfolio management/DA processes. Drive the development of functional plans, update plans appropriately, and manage the process to ensure Governance Board review and approval of changes to plan. Basic Qualifications Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications - Demonstrated experience in project management, business analysis, or managing and/or coordinating domestic and/or international product development - Project Management Professional (PMP) certification desired - MS, MBA or PhD - 7 or more years of experience in cross-functional pharmaceutical development project teams and/or experience with project management practice within the pharmaceutical industry - Experience working on late stage product development - Experience working on BLA/NDA regulatory filing activities - Experience in oncology drug development - Experience in preparing for product launch - Excellent verbal and written skills2012-05-22 19:47:52United StatesAmgenCalifornia15758BRCAThousand Oaks, CA28868639http://www.amgen.jobs/xml/28868639/jobUSAThousand OaksAuto req 15741BR Job Posting Title Sr Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Serve as a technical expert on a drug product team to support commercialization and trouble shooting of manufacturing process. Activities will pertain to process design, scale-up, characterization and technology transfer of drug product manufacturing operations for validation and registration of protein parenteral products. The responsibilities include designing and executing bench and pilot scale experimentation, applying sound scientific theory to experimental work, and optimizing various unit operations including protein freeze/thaw, ultrafiltration/diafiltration, formulation, sterile filtration, mixing, vial and syringe filling and lyophilization. Also conducts experiments, analyzes data, writes technical reports and assessments, and communicates frequently with management and team members. She/he serves as a reliable technical resource for clinical manufacturing support and scale-up of drug product operations for commercial production. The candidate will need to participate in cross-functional teams and work effectively in a highly matrixed team environment. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or Life Sciences with a pharmaceutical, vaccine, or biotechnology background with 3 + years experience in biotech/pharmaceutical industry. • Experience with formulation and filling process steps of cryopreservation, lyophilization, vial and syringe filling, sterile filtration, and aseptic processing is preferred. • Experience with statistical analysis, design of experiments, and writing/reviewing technical and manufacturing documents. • Experience with process development for Phase I – III biologic drug products. • Travel may be required.2012-05-22 19:47:29United StatesAmgenCalifornia15741BRCAThousand Oaks, CA28868627http://www.amgen.jobs/xml/28868627/jobUSAThousand OaksAuto req 15616BR Job Posting Title Feasibility & Patient Recruitment Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Manager, Feasibility & Patient recruitment will establish strategies and decision making processes to address the barriers in reaching goals around feasibility and identifying and recruiting appropriate patient populations within established timelines. There are many responsibilities associated with this role key to ensuring the timely and effective delivery of Amgen’s strategy to its stakeholders including: setting project timelines and priorities based on study objectives and ongoing assignments; organizing and leading cross-functional meetings to develop and execute the enrollment forecasting strategies for our programs; identifying patient profiles, patient market dynamics, potential recruitment barriers, regional recruitment boundaries, triggers, contingency plans and implementation plans by country and site. Additionally, this individual will serve as a consultant and advisor to study teams and regions to help them maximize their enrollment rates. He/She will also gather historic regional performance data, track and report successes of various recruitment strategies and manage the inventory of recruitment tools and recruitment vendors and communicate best practices to teams and site management staff ensuring accurate and timely information exchange between departments. Also critical to the success of this role, will be maintaining therapeutic knowledge of Amgen products; knowledge of performance measurement at a departmental level and a fundamental understanding of the organizational change management process. Basic Qualifications ?Doctorate degree OR ?Master’s degree & 3 years of directly related experience OR ?Bachelor’s degree & 5 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience Preferred Qualifications Advanced Degree preferred - Excellent communication, organizational, and interpersonal skills - Ability to plan and work on projects with minimal supervision - Effective at working with colleagues from all departments and organizational levels while meeting commitments. - Experience working as a member of global drug development teams preferred - Previous management experience of direct reports or clinical projects Proven experience in a pharmaceutical environment - Good experience of biopharmaceutical clinical research - Experience involving a broad exposure to biopharmaceutical clinical development process and procedures - Experience developing and implementing recruitment and retention plans - Experience working independently across departments within a team/matrix environment -Detailed knowledge of international clinical research and drug development - Strong understanding of program and study operations in an international setting -Relevant therapeutic area(s) - Strong computer literacy, including word processing, presentation, spreadsheet and project management applications - Organizational change management process2012-05-21 18:12:39United StatesAmgenCalifornia15616BRCAThousand Oaks, CA28833051http://www.amgen.jobs/xml/28833051/jobUSAThousand OaksAuto req 15637BR Job Posting Title Associate Manufacturing Career Category Operations Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Under general supervision, performs manufacturing unit operations according to Manufacturing Procedures (MPs) and Standard Operating Procedures (SOPs). Specific Job Duties: This is a production floor position supporting fermentation and or purification unit operation execution. - Use understanding of process theory to perform and monitor critical processes. - Perform routine manufacturing operations and operate equipment in the manufacturing area. - Execute routine validation protocols. - Set-up, clean, and sanitize labware and equipment. - Prepare media and/or buffers and other process materials. - Recognize & accurately report problems. - Generate and own class 1 non-conformances. - Participate in resolving problems during operations. - Document activities as appropriate (i.e., MPs and logs) using Good Documentation Practices (GDPs). - May draft and revise documents (e.g., SOPs). - Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records). - Comply with and reinforce cGMPs and safety requirements. Basic Qualifications • Bachelor’s degree OR • Associate’s degree & 4 years of directly related experience OR • High school diploma / GED & 6 years of directly related experience Preferred Qualifications - Bachelor’s degree in Science or Engineering and 3 years experience in a biotech/pharma manufacturing environment or /manufacturing support role (i.e. laboratories, engineering, utilities/facilities, quality). - Ability to assemble, disassemble, operate, and understand complex equipment per procedures. - Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT). - Ability and willingness to work any day, swing, or grave shift in support of operations that may include 24/7. - Ability to understand, apply, and evaluate basic chemistry, biology and physical principles as appropriate for the position. - Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment. - Documentation skills. - Written and oral communication skills. Proficiency in reading and writing English. - Basic problem solving skills. - Ability to lift 30 lbs.2012-05-21 18:12:07United StatesAmgenCalifornia15637BRCAThousand Oaks, CA28833041http://www.amgen.jobs/xml/28833041/jobUSAThousand OaksAuto req 15634BR Job Posting Title Compliance Sr Mgr, Global Privacy and Data Protection, Policies, Training and Communication Career Category Compliance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Experienced Privacy Professional to work in the Worldwide Compliance and Business Ethics Department of a global pharmaceutical/biotechnology company (Company”) located in Southern California. The individual will report directly to the Chief Privacy Officer and will: • Develop, lead and continuously improve, in collaboration with the Chief Privacy Officer, programmatic efforts designed to build effective global and cross-functional privacy and data protection controlled documents (including policies, procedures, templates and forms), training and communication in a manner conducive to the success of the business • Develop and maintain a multi-year plan outlining the strategy for development and execution of global and cross-functional privacy and data protection-related controlled documents, training and communication • Anticipate project challenges, troubleshoot, problem solve, recommend solutions • Author, update, maintain and serve as subject matter expert on privacy and data protection-related controlled documents, working objectively to analyze compliance issues or concerns • Develop and design comprehensive long-term sustainable role-based training curricula for privacy roles globally • Serve as a subject matter expert on both policy and training content for targeted and company-wide privacy and data protection-related training courses • Provide official interpretation of privacy and data protection-related controlled documents to stakeholders, as warranted, including the preparation of official clarifications or guidance documents based on appropriate inputs (such as legal, regulatory, and business inputs) • Perform research on privacy and data protection-related laws, regulations, and industry developments and interpret their impact on Company’s business practices and policies • Engage with attorneys to ensure that privacy and data protection-related controlled documents, training and communication efforts meet legal and regulatory expectations and are implemented to support identified needs • Collaborate with local and international colleagues to develop appropriate and usable global and regional controlled documents, training and communications • Respond to Audit and Investigations findings by determining appropriate privacy and data protection-related actions based on audit requirements • Annually assess controlled documents and training to determine what revisions are warranted • Own and manage projects and reporting on progress, obstacles, and execution • Manage the ongoing revisions of controlled documents • Issue and track the issuance of controlled documents, both internally and with vendors and external service providers • Benchmark our privacy and data protection-related policies and training against those of our peers • Represent Global Privacy Office on corporate cross-functional working teams • Support the global privacy and data protection needs of Company’s Global Operations and Manufacturing function • Prepare for and deliver regular management reviews and operating reviews Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Responsibility for developing and implementing global, cross-functional policy, training and communications initiatives, including creation of global annual and multi-year plans • 2+ years of relevant privacy experience at a law firm or global company • Strong working knowledge of global privacy and data protection laws and regulations • Substantial experience building and/or implementing global and cross-functional policy, training and communication efforts including annual/multi-year planning (global experience preferred) • Strong strategic thinking skills and ability to translate strategy into action plans • Excellent ability to interact and build relationships at all levels of management and staffing across organizational/jurisdictional boundaries • Ability to understand, plan and navigate in a matrix environment • Excellent project management skills • Excellent command of English (spoken and written) and public-speaking skills • Availability in crisis • Understanding of global aspect of position • Strong working knowledge of SharePoint, EDMQ and Articulate software and instructional design • Self-starter with a high level of initiative and strong work ethic • Significant experience working with senior management, including both internal and external law departments • Meaningful ability to effectively and timely manage multiple initiatives and cross-departmental projects (i.e., strong project management skills). • Proven ability to multi-task, thrive and deliver in a highly-regulated and increasingly-demanding matrixed corporate environment. Demonstrated ability to regularly re-prioritize risks, objectives and action plans based on an evolving corporate and regulatory landscape. Ability to deal well with ambiguity and complex situations. • Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude. • Strong knowledge of applicable global privacy and data protection laws and regulations as well as ability to perform research to identify and interpret such laws and regulations. • Demonstrable political acumen to collaborate, drive results and influence cross-organizational stakeholders and decision makers with different operational and jurisdictional responsibilities. • Significant company representation (preferably public) • Proven communication, relationship-building and collaboration skills • Responsibility for building, improving and/or re-engineering projects and programs • Development and updating of intra- and internet content • Familiarity with in-house learning management systems • Crisis management and handling • Proven commitment to delivering high-quality and timely output • Proven to have a strong work ethic demonstrated by being self-starter, resourceful and able to participate in a highly collaborative team-oriented environment Additional Competencies/Skills: • Effective leadership skills • Effective organizational and creative problem solving skills • Strong understanding of the role of compliance professionals • Healthcare/pharmaceutical company experience • CIPP certification from the International Association of Privacy Professionals • Willingness to travel2012-05-21 18:12:06United StatesAmgenCalifornia15634BRCAThousand Oaks, CA28833040http://www.amgen.jobs/xml/28833040/jobUSAThousand OaksAuto req 15775BR Job Posting Title Executive Medical Director Global Development - Neurology Career Category Clinical Development Employee Subgroup Executive FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The neuroscience group is looking for a Global Development Leader to serve as co-lead on a multidisciplinary strategy team for a neuroscience product. This position will be located in Thousand Oaks, California. The ideal candidate will represent the unified global medical voice and be the single point of accountability for evidence generation and scientific communication. The candidate will also be responsible for developing and executing the global scientific/medical evidence plan, collaborating cross-functionally and globally to integrate broad medical, scientific, and commercial input into the program and approving medical and scientific content of Regulatory, Safety, Scientific Affairs, and Commercial outputs. Key Activities include the following: Scientific - Oversee activities related to planning for studies across the product lifecycle - Interpret and integrate the results of research programs (e.g. study data, competitor data, publications) into the overall program strategy - Provide input to regulatory and safety groups for queries from regulatory agencies and negotiate with these groups - Provide medical and scientific input into key deliverables (e.g., regulatory filings and interactions, clinical study reports, publications and reimbursement submissions) - Provide strategic medical input into all aspects of the Commercialization process (pre-clinical through launch) - Approve medical/scientific components of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial materials and outputs - Communicate current safety and efficacy/effectiveness status of the product internally and externally - Review, approve, and execute publication plan - Provide medical support for licensing activities and support partner relationships Leadership, Collaboration and Management - Co-lead multidisciplinary product strategy team with the Global Commercial Leader - Co-author Global Strategic Plan - Lead Global Development Team and represent the team in Multidisciplinary and Senior Management Interactions - Mentor, coach, and oversee the performance of direct reports - Provide oversight and ensure alignment between clinical development and development operations. - Provide medical/scientific support to other functions as appropriate - Support regional needs for medical/scientific evidence generation - Develop key relationships with global opinion leaders Knowledge - Proven success in development and execution of clinical trials - Excellent knowledge of disease states in therapeutic area - Familiar with investigators or institutions in therapeutic area - Knowledge of regulatory affairs and drug safety - Proven track record in publications - Proven track record in commercialization and business practices - Documented success leading, managing and motivating staff in a complex, multi-functional matrix environment Basic Qualifications MD • Five (5) or more years of either industry or academic research experience • Previous management experience Preferred Qualifications Preferred Qualifications • MD plus accredited residency in relevant sub-specialty (ie, Neurology), board certified • Eight (8) or more years of either industry or academic research experience • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) • Clinical research experience with Migraine programs2012-05-21 18:11:47United StatesAmgenCalifornia15775BRCAThousand Oaks, CA28833024http://www.amgen.jobs/xml/28833024/jobUSASan Francisco - Field BasedAuto req 15782BR Job Posting Title Sr Biopharmaceutical Rep, Bone Health - Berkley, CA Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - California Location (City) San Francisco - Field Based Amgen Job Description Territory #58317 Berkley, CA - covering - east bay area-Walnut Creek, Berkeley, Lafayette, Oakland Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. As a Sr Biopharmaceutical Rep, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications 2 years of sales and/or marketing experience within pharmaceutical, biotech or healthcare industries Previous experience selling in the osteoporosis market. Expert local knowledge in the primary care or specialty market. Successful launch experience in a highly competitive market. Outstanding business acumen including experience with: Medicare Part B Contracting Managed Care or pull-through Capital equipment or durable medical device sales Proven strategic account management Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve2012-05-21 18:11:43United StatesAmgenCalifornia15782BRCASan Francisco - Field Based, CA28833020http://www.amgen.jobs/xml/28833020/jobUSAThousand OaksAuto req 15638BR Job Posting Title Compliance Sr Mgr, Global Privacy and Data Protection Incident, Inquiry, Monitoring and Reporting Career Category Compliance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Experienced Privacy Professional to work in the Worldwide Compliance and Business Ethics Department of a global pharmaceutical/biotechnology company (Company”) located in Southern California. The individual will: (1) report directly to the Chief Privacy Officer, (2) develop and lead, in collaboration with the Chief Privacy Officer, programmatic efforts designed to build an effective global privacy and data protection incident, inquiry, monitoring and reporting function, (3) collaborate and work directly with in-house and external attorneys responsible for global privacy and data protection, (4) interact with global senior Company management as well as governmental agencies; (7) lead and direct the data protection efforts undertaken by the internal team dedicated to identifying, containing and remediating any found privacy and/or data protection vulnerabilities; (8) implement and execute effective testing, auditing, monitoring, tracking and reporting procedures and programs to ensure the success of the program, as measured by regular assessments and metric-based analysis; (9) compile clear, accurate and timely reports for senior management and the Board of Directors, as needed; (10) to support the Chief Privacy Officer in preparing Operating and/or Management Reviews, as required; and (11) support the global privacy and data protection needs of Company’s Global Research and Development function. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Candidate should have legal training and 2+ years of relevant international privacy/data protection experience at a law firm or global company, including experience managing personal data incident inquiry and response efforts, implementing effective testing, monitoring, tracking and reporting procedures and programs, and compiling clear, accurate and timely reports for senior management including a Board of Directors • Health care/pharmaceutical company and multiple data stream (e.g., employee, vendor, customer, patient) experience, is a plus • Candidate should also possess a working knowledge of information technology/security capabilities • Experience should include meaningful project direction and coordination responsibility; significant experience working with senior management, including both internal and external law departments • Significant company representation (preferably public); and responsibility for global, cross-functional data protection initiatives • Candidate must be able to handle, prioritize and follow through on diverse issues on a timely basis. Candidate must be a self-starter and hard worker, resourceful and able to participate in a highly collaborative team-oriented environment. • Proven ability to effectively and timely manage multiple initiatives and cross-departmental projects (i.e., strong project management skills). • Proven ability to multi-task, thrive and deliver in a highly-regulated and increasingly-demanding matrixed corporate environment. • Demonstrated ability to regularly re-prioritize risks, objectives and action plans based on an evolving corporate and regulatory landscape. • Ability to deal well with ambiguity and complex situations. • Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude.• Demonstrable political acumen to collaborate, drive results and influence cross-organizational stakeholders and decision makers with different operational and jurisdictional responsibilities. • Proven communication, relationship-building and collaboration skills. • Experience in building programs, process improvements and/or re-engineering. • Experienced in crisis management and handling. • Proven commitment to delivering quality and timely output. • Legal training • 2+ years of relevant privacy experience at a law firm or global company • Strong awareness of global privacy laws and regulations and experience with associated compliance • Substantial experience building and/or implementing operational privacy and data protection programs in a corporate environment (global experience preferred) • Strong strategic thinking skills and ability to translate strategy into action plans • Excellent ability to interact and build relationships at all levels of management and staffing across organizational/jurisdictional boundaries • Ability to understand, plan and navigate in a matrixed environment • Excellent project management skills • Excellent command of English (spoken and written) and public-speaking skills • Availability in crisis • Strong working knowledge of information technology systems would be an advantage • Understanding of global aspect of position • Effective leadership skills • Effective organizational and creative problem solving skills • Self-starter with a high level of initiative and strong work ethic • Strong understanding of the role of compliance professionals • Healthcare/pharmaceutical company experience2012-05-21 18:11:30United StatesAmgenCalifornia15638BRCAThousand Oaks, CA28833012http://www.amgen.jobs/xml/28833012/jobNLDBredaAuto req 15718BR Job Posting Title Clinical Operations Manager Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Field Based Amgen Job Description Initiates and coordinates feasibility assessment, potential investigator identification and site selection Strategically plans and coordinates Amgen sponsored trials (forecasting, resourcing, timelines, baseline recruitment) Adapt ICF to local requirements Defines study specific processes including study communication plans Ensures all study staff understand study deliverables and timelines Tracks local trial implementation, data collection and study reporting Reviews and approves monitoring reports and Site Initiation Packages (SIPs) Responsible with Medical staff for vendor selection and performance evaluation for local studies, including HE studies (services other than FSP) Provides regular updates on study progress to DOM and study sponsors as required, identifying barriers to site activation and patient enrollment and identifying potential solutions Ensures quality of study execution Escalates study-related issues Provides Amgen presence at investigator meetings / key visits Coordinate & actively participate at local investigators meetings Review GCA Site audit reports and work in conjunction with FSP staff and Site staff as required to fix issues Key interface with Safety reporting group to oversee collection and distribution of safety reports from sites via FSP, including query follow up Project manages local clinical study teams Coordinates SACOM tasks, according to the COM-SACOM RASCI, when those are allocated to support COMs in the oversight of operational activities related to planning, executing and reporting of phase 3 / 4 studies Single point of contact at a project level for LOC staff and GSM Partners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs) Identifies and highlights risk areas (concerning operational readiness, communication and management) Ensures CRA receives necessary TA-related and study-related training Coordinates local study-related administrative tasks e.g. information to finance, status update to BU, status updates in local meetings Actively participates in the regional COM network as required Participate in the hub or country level Functional Management Team (FMT Governance) Basic Qualifications BA/BS/BSC or qualified nurse (RN) work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company or other relevant clinical setting) Preferred Qualifications Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company Clinical trial management experience Operational performance measurement experience International collaboration experience2012-05-21 18:11:05NetherlandsAmgenNone15718BRNoneBreda, NLD28832994http://www.amgen.jobs/xml/28832994/jobUSAThousand OaksAuto req 15617BR Job Posting Title Feasibility & Patient Recruitment Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Manager, Feasibility & Patient recruitment will establish strategies and decision making processes to address the barriers in reaching goals around feasibility and identifying and recruiting appropriate patient populations within established timelines. There are many responsibilities associated with this role key to ensuring the timely and effective delivery of Amgen’s strategy to its stakeholders including: setting project timelines and priorities based on study objectives and ongoing assignments; organizing and leading cross-functional meetings to develop and execute the enrollment forecasting strategies for our programs; identifying patient profiles, patient market dynamics, potential recruitment barriers, regional recruitment boundaries, triggers, contingency plans and implementation plans by country and site. Additionally, this individual will serve as a consultant and advisor to study teams and regions to help them maximize their enrollment rates. He/She will also gather historic regional performance data, track and report successes of various recruitment strategies and manage the inventory of recruitment tools and recruitment vendors and communicate best practices to teams and site management staff ensuring accurate and timely information exchange between departments. Also critical to the success of this role, will be maintaining therapeutic knowledge of Amgen products; knowledge of performance measurement at a departmental level and a fundamental understanding of the organizational change management process. Basic Qualifications ?Doctorate degree OR ?Master’s degree & 3 years of directly related experience OR ?Bachelor’s degree & 5 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience Preferred Qualifications Preferred Qualifications - Advanced Degree preferred - Excellent communication, organizational, and interpersonal skills - Ability to plan and work on projects with minimal supervision - Effective at working with colleagues from all departments and organizational levels while meeting commitments. - Experience working as a member of global drug development teams preferred - Previous management experience of direct reports or clinical projects Proven experience in a pharmaceutical environment - Good experience of biopharmaceutical clinical research - Experience involving a broad exposure to biopharmaceutical clinical development process and procedures - Experience developing and implementing recruitment and retention plans - Experience working independently across departments within a team/matrix environment -Detailed knowledge of international clinical research and drug development - Strong understanding of program and study operations in an international setting -Relevant therapeutic area(s) - Strong computer literacy, including word processing, presentation, spreadsheet and project management applications - Organizational change management process2012-05-21 18:10:58United StatesAmgenCalifornia15617BRCAThousand Oaks, CA28832988http://www.amgen.jobs/xml/28832988/jobUSAField BasedAuto req 11978BR Job Posting Title Sr Biopharmaceutical Rep, Inflammation - Fort Worth S, TX Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Texas Location (City) Field Based Amgen Job Description Territory #33707, Fort Worth S - covers, Fort Worth, Arlington, Midland As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-05-21 18:10:40United StatesAmgenTexas11978BRTXField Based, TX28832969http://www.amgen.jobs/xml/28832969/jobUSAThousand OaksAuto req 15771BR Job Posting Title Biostatistical Programming Mgr Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Biostatistical Programming Manager will be accountable for Global Statistical Programming (GSP) study activities and oversight of contingency workers within the product team. This role is part of a Therapeutic study team located at Amgen's headquarters in Thousand Oaks, CA . The Biostatistical Programming Manager is responsible for: • Writing, testing and validating software programs in UNIX to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications • Writing and/or reviewing statistical programming plans and dataset specifications. • Ensuring the analysis and presentation of biomedical data is accurate and complete. • Adherence to Amgen Policies, SOPs and other controlled documents Basic Qualifications • Bachelor’s degree & 5 years of directly related experience Preferred Qualifications • MS degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject • Biostatistical Programming using the SAS System • Drug Development (pre-, early, late and/or observational) in related industries or academic research • Project planning • Process improvement participation • International co-operation • Team participation and effectiveness • Six (6) years relevant career experience2012-05-20 19:44:41United StatesAmgenCalifornia15771BRCAThousand Oaks, CA28824683http://www.amgen.jobs/xml/28824683/jobUSAThousand OaksAuto req 15090BR Job Posting Title Principal IS Architect - Principal Design Engineer Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Job Summary The Principal Design Engineer for Amgen's Enterprise IS Technology Services (EISTS) Design & Engineering is part of a team responsible for the development, delivery, and life cycle of all Amgen IS Infrastructure technologies. Multiple cross-disciplinary experts are being sought to provide Engineering direction across the Infrastructure organization in their areas and relationships to other areas. This position will deliver timely designs and implementations from the existing technology portfolio, create new solutions, and maintain the technology portfolio life cycle. Job Responsibilities • Be accountable for developing, delivering and maintaining an integrated set of designs, detailed specifications, roadmaps and program delivery for solutions from their areas. • Ensure the relevance and completeness of designs and delivered solutions to EISTS service owners. • Accountable to ensure IS projects leverage and maximize value Engineered solutions from their portfolio of technologies through strong collaboration within EISTS and across IS. • Provide technical leadership and implementation support to projects requiring cross-functional integration expertise, including co-development of project plans. • Lead the introduction of new EISTS Technologies into their portfolio to enable business value driven innovation while maximizing organizational effectiveness and efficiency. • Maintain the technology portfolio life cycle for their areas within EISTS, including driving the retirement of obsolete or declining technologies and delivery of successor technologies to enable efficient service provision and minimize risks. • Lead alignment of services and operations for their areas within EISTS, to increase efficiency and reduce the risk of unmanaged faults in the service and operational pipeline. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Master’s degree • Bachelor’s Degree in Information Systems, Computer Science, or Electronics • 10 + years experience working within Information Systems • 7+ years experience delivering large and small IS infrastructure technology solutions in global companies using Information Technology and Services in regulated environments. Additional experience with technology supply and sourcing companies a plus. • 5+ years developing integrated business-to-business and business-to-consumer solutions, including detailed technical experience with key Internet technologies and protocols • 5+ years experience with service design and operational alignment. Specific experience applying ITIL to infrastructure service delivery and operation is a plus • 5+ years biotechnology or pharmaceutical experience are a plus. • Strong leadership and communication skills to convince all stakeholders on programs and portfolio investments. • The ability to function in multiple roles based on project demands. • Strategic delivery experience and ability to facilitate alignment and investment across multiple geographies, functions, and disciplines. • Excellent oral, written and interpersonal communication skills. • Experience with a range of IT service, architecture, engineering, and design frameworks and languages • This position requires a senior and credible IS Infrastructure technology design and delivery engineer, with broad experience and demonstrated success. It requires a passion for Information Technology and engineering, in depth understanding of Infrastructure technologies, of technology integration, and of industry practices. • Learning agility, technical excellence, discipline and the capability to engage and collaborate across the IS Function in a relationship based organization to drive change and continuous improvement at all levels are essential attributes. • This individual will leverage his/her extensive experience in designing and delivering global information infrastructure systems in a regulated environment for the Enterprise and a diverse range of specialized business needs and partner with business IS and other Enterprise shared services2012-05-20 19:42:38United StatesAmgenCalifornia15090BRCAThousand Oaks, CA28824682http://www.amgen.jobs/xml/28824682/jobUSAThousand OaksAuto req 15091BR Job Posting Title Principal IS Architect - Principal Design Engineer Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Job Summary The Principal Design Engineer for Amgen's Enterprise IS Technology Services (EISTS) Design & Engineering is part of a team responsible for the development, delivery, and life cycle of all Amgen IS Infrastructure technologies. Multiple cross-disciplinary experts are being sought to provide Engineering direction across the Infrastructure organization in their areas and relationships to other areas. This position will deliver timely designs and implementations from the existing technology portfolio, create new solutions, and maintain the technology portfolio life cycle. Job Responsibilities • Be accountable for developing, delivering and maintaining an integrated set of designs, detailed specifications, roadmaps and program delivery for solutions from their areas. • Ensure the relevance and completeness of designs and delivered solutions to EISTS service owners. • Accountable to ensure IS projects leverage and maximize value Engineered solutions from their portfolio of technologies through strong collaboration within EISTS and across IS. • Provide technical leadership and implementation support to projects requiring cross-functional integration expertise, including co-development of project plans. • Lead the introduction of new EISTS Technologies into their portfolio to enable business value driven innovation while maximizing organizational effectiveness and efficiency. • Maintain the technology portfolio life cycle for their areas within EISTS, including driving the retirement of obsolete or declining technologies and delivery of successor technologies to enable efficient service provision and minimize risks. • Lead alignment of services and operations for their areas within EISTS, to increase efficiency and reduce the risk of unmanaged faults in the service and operational pipeline. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Master’s degree • Bachelor’s Degree in Information Systems, Computer Science, or Electronics • 10 + years experience working within Information Systems • 7+ years experience delivering large and small IS infrastructure technology solutions in global companies using Information Technology and Services in regulated environments. Additional experience with technology supply and sourcing companies a plus. • 5+ years developing integrated business-to-business and business-to-consumer solutions, including detailed technical experience with key Internet technologies and protocols • 5+ years experience with service design and operational alignment. Specific experience applying ITIL to infrastructure service delivery and operation is a plus • 5+ years biotechnology or pharmaceutical experience are a plus. • Strong leadership and communication skills to convince all stakeholders on programs and portfolio investments. • The ability to function in multiple roles based on project demands. • Strategic delivery experience and ability to facilitate alignment and investment across multiple geographies, functions, and disciplines. • Excellent oral, written and interpersonal communication skills. • Experience with a range of IT service, architecture, engineering, and design frameworks and languages • This position requires a senior and credible IS Infrastructure technology design and delivery engineer, with broad experience and demonstrated success. It requires a passion for Information Technology and engineering, in depth understanding of Infrastructure technologies, of technology integration, and of industry practices. • Learning agility, technical excellence, discipline and the capability to engage and collaborate across the IS Function in a relationship based organization to drive change and continuous improvement at all levels are essential attributes. • This individual will leverage his/her extensive experience in designing and delivering global information infrastructure systems in a regulated environment for the Enterprise and a diverse range of specialized business needs and partner with business IS and other Enterprise shared services2012-05-20 19:42:07United StatesAmgenCalifornia15091BRCAThousand Oaks, CA28824681http://www.amgen.jobs/xml/28824681/jobTURField BasedAuto req 15762BR Job Posting Title Sr Biopharmaceutical Rep Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) Turkey Location (City) Field Based Amgen Job Description Provides input and agrees to territory annual sales objectives with manager Collaborates with manager to develop and implement territory POA and key account plans Collaborates with relevant stakeholders (Medical Affairs, etc.) to agree on account plan objectives/responsibilities Evaluates progress vs. plan monthly, and agrees to course corrections with manager where necessary Develops and maintains up-to-date customer/market understanding Reports customer activity in the CRM system and ensures customer profiles are kept up-to-date Details products in accordance with Amgen’s sales process and agreed marketing strategy Provides feedback to product/sales management on competitor activity Operates within the agreed expense budget Continuously develops and improves product knowledge, communication and selling skills through self-learning and active participation in agreed training programs Ensures open communication and shares best practices Participates in the Amgen Performance Management System (MAP) Basic Qualifications Minimum 3 to 5 years of experience in the pharmaceutical industry in a sales-related job Some experience with computer systems (CRM databases and MS Office) Preferred Qualifications Bachelor’s degree in life science or (bio) medical sciences Knowledge of Customer Relation Management principles Exposure to interactions with various disciplines and organizational levels Exposure to project management principles Fluency in English, both in oral and written communication2012-05-18 18:07:55TurkeyAmgenNone15762BRNoneField Based, TUR28792893http://www.amgen.jobs/xml/28792893/jobUSAThousand OaksAuto req 15636BR Job Posting Title Sr Assoc Clinical Trial Mgmt Systems Career Category Clinical Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Review and track global organizational performance metrics Highlight performance gaps and identify root cause; recommend meaningful improvement opportunities Co-ordinate the creation and distribution of metrics reports and other status reports as required Manage benchmarking efforts Initiate and build relationships with study teams and business partners to understand study requirements Develop protocol builds and budgets to meet study team requirements Partner with appropriate Dev IS resources on CAAS tools to meet client needs Collaborate with appropriate Dev IS resources of other systems to ensure consistency of data standards and quality Create and distribute written materials to support training, data integrity, or other special projects (as assigned) Provide clients with outstanding support through effective communications and robust processes Lead special projects as assigned Gather stakeholder requirements on applications, metrics and reports Develop processes and reporting to ensure compliance to data standards and compliance to business processes Basic Qualifications Master’s degree OR Bachelor’s degree & 2 years of directly related experience OR Associate’s degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience Preferred Qualifications BA/BS/BSc in the sciences or RN Specialist work experience in business support role in the life sciences or medically related field 5 years work experience in life sciences or medically related field, including 2 years of clinical development experience involving clinical applications (e.g. CTMS, IVRS, EDC2012-05-18 18:07:27United StatesAmgenCalifornia15636BRCAThousand Oaks, CA28792892http://www.amgen.jobs/xml/28792892/jobUSABoulderAuto req 15751BR Job Posting Title Corporate Account Mgr - Southwest PPM CAM Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Arizona United States - Colorado United States - Missouri United States - Nebraska United States - New Mexico United States - Oklahoma United States - South Dakota United States - Texas United States - Utah United States - Wyoming Location (City) Boulder Field Based Lake Centre Longmont Amgen Job Description Territory #17001 - Southwest PPM CAM Area covered: TX, AZ, NM, UT, CO, OK, WY, Arkansas, W. S Dakota, W. Nebraska, S. Missouri, N. Louisiana The PPM (Physician Practice Management) Corporate Account Manager's primary responsibility is to Assess and diagnose the current business environment in each key account in relation to Amgen Oncology products and plan actions required for success in these accounts. • Develop and implement in partnership with BSR/DM, a comprehensive business plan to gain trial and adoption of Aranesp, XGEVA, and Neulasta. Plan will include but not limited to comprehensive account profile, business strategies, financial models, key result areas, information systems, inventory management strategies, competitive intelligence for each account, current resources being utilized, new resources to be implemented, action plan for key personnel, timelines for execution of above, follow-up action steps to ensure compliance, and coordination / procurement of all available resources. (Primary customers include executive management (CEO, CFO, Director of Pharmacy Services, or fiscal intermediaries), medical directors, and key physicians and secondary customers include pharmacists and nurses). • Facilitates account management by coordinating selling activities and customer interactions through effective leadership, communication and implementation with field sales staff to ensure appropriate customer needs are met. • Implements approved plans and monitors plan execution against targets. • Develops and implements business reviews of key accounts on at least a quarterly basis with RSDs and GPO NAMs • Serve as a resource at RSD discretion for DM's/BSR's when appropriate for accounts within their districts / territories. Will include joint customer calls, consultation on clinic accounts outside of assigned key accounts, and specific skill building with BSR's on clinic selling. • Participates in other projects as assigned by management. Environment: Driving/Extensive Travel including overnights (up to 75% of time). • Excellent interpersonal skills, which include networking, influencing, negotiation, presentation and written and verbal communication. • Demonstrated Business Acumen and Excel skills. • Demonstrated leadership ability with a focus on influence, impact and leading without authority. • Requires excellent customer service skills. • Ability to work independently. • Ability to understand and identify key staff and departments that influence decision-making for biopharmaceutical product utilization within each key account, then maintain and grow relationships with these key decision makers within the accounts • Ability to identify and obtain appropriate Amgen resources to achieve account objectives. • Contract negotiation. • Ability to analyze and interpret clinic economics/financial performance. • Ability to successfully navigate through clinic reimbursement. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications •• BA/BS degree • 7+ years of healthcare sales and/or marketing experience • Clinic, hospital, oncology, injectable experience preferred • Reimbursement/managed care experience preferred • Advanced Degree preferred • Strong business acumen and analysis skills • Proficient with Excel and PowerPoint • Demonstrated track record of success Discretion: Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives. Impact: Failure to obtain results or erroneous decisions or recommendations would usually result in financial impact. Liaison: Frequent inter-organizational and outside customer contacts. ‘Do It’ level of competency development as defined by the ACT competency model in: Professional Mastery, Managing the Business, Communication, and Leadership with focus on: Excellent communication skills, organizational skills and presentation skills to senior level management. Understand financial impact of Amgen products. Translates brand planning/POA into account specific business plans. Ability to work in teams, to coordinate development of Amgen account teams to cross-functionally match players between organizations. Ability to maintain and grow customer relationships. Negotiation skills. Proven analytical skills / business acumen especially in the area of resource allocation. Ability to analyze and interpret complex clinical problems2012-05-18 18:07:26United StatesAmgenArizona15751BRAZBoulder, AZ28792891http://www.amgen.jobs/xml/28792891/jobGBRCambridgeAuto req 15726BR Job Posting Title Regulatory Affairs Director - Biosimilars Policy Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Uxbridge Amgen Job Description Overview: The Global Regulatory Affairs and Safety (GRAAS) Biosimilar Policy Director is accountable for defining Amgen positions on the scientific, medical and regulatory aspects of biosimilars. Advocating those standards to external policy makers while concurrently providing key internal subject-matter expertise to cross-functional executive leadership and teams Responsibilities: • Develop, direct and deliver strategic regulatory plans that are in-line with regulatory and business needs • Develop innovative solutions to complex problems through in-depth analysis, coordination and negotiation with subject-matter experts and key decision makers • Work in partnership with cross-functional teams and Amgen leadership to develop regulatory plans that support the direction of the business • Advocate to a broad spectrum of internal and external stakeholders the adoption of policies for achieving regulatory and business goals • Develop mutually beneficial strategic alliances with internal and external subject-matter experts and external key decision makers • Engage in direct advocacy with national, regional and global policy makers and regulators • Represent Amgen and the innovator industry in policy testimony and on trade association key issue team • May have direct reports, but spends more than 50% of their time working as a individual contributor Key Relationships: • Internal cross-functional project teams (national, regional and global) • Amgen leadership teams • Internal subject-matter experts and external key decision makers • Government and Regulatory Agency officials Basic Qualifications • University degree with significant directly related experience Preferred Qualifications • Science-background (eg. BSc, PhD, MD) • Experience in regulatory or clinical development, ideally with biologics • Understanding of national and global healthcare system, including payers • Critical thinker, able to analyze and critique data • Intellectually creative, able to assess a situation from multiple perspectives • Skilled and credible advocate with experience in 1:1 engagement, large audiences, panel debates • Able to form and defend a position under challenge2012-05-18 18:07:00United KingdomAmgenNone15726BRNoneCambridge, GBR28792889http://www.amgen.jobs/xml/28792889/jobUSAThousand OaksAuto req 15609BR Job Posting Title GRAAS Operations Senior Manager Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The focus of this group is to support the business and project needs of the GRAAS International Region through detailed strategic planning and delivery of analytical, logistical, financial, and organisational data, support and advice. Specifically, this job provides comprehensive strategic business & operations support within GRAAS International across a broad range of strategic issues (governance, organisation, productivity, etc.) and assist the GRAAS International Core Senior Management Team (SMT) in effective and productive leadership and management of the GRAAS International business and organisation and internal and external communication. Key activities include: - Provide strategic and operational support including strategic planning and communications, operational project management and implementation of functional projects - Contribute through SME or facilitation to department and/or cross-functional projects and process improvement initiatives - Support for the (sub-functional) leadership through tracking of project progress, issue tracking, problem solving, organizational management, and presentation development - Implement tools, techniques and processes to enable continuous improvement across GRAAS International regions - Provide cross-functional and GRAAS internal communications where applicable - Support and/or direct leadership of various external development initiatives partnering with global functions and regional leaders - Provide strategic analysis managing benchmarking to capture industry best practices, organization design and operations for critical business functions - Develop and manage budgets and contribute to the International budget process (if requested) - Manage special projects, as required. - Ensure cross-functional liaison (e.g. ICO, GDO, Operations) - Contribute through influence and direct support to the activities and goals of other international functions - Support to GRAAS International VP and /or GRAAS International Core Senior Management Team (SMT)members with International governance forums (e.g. IMC, ISC, EMST and RMCs) Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - Solid understanding of working within global complex matrix organisations - Ability to engage different personalities - Ability to influence - Motivating and leading (cross functional) teams on a functional level - Strong critical thinking - Planning and Prioritisation - Good interpersonal skills - Knowledge of the fields of Regulatory & Safety and biopharmaceutical industry - Excellent communication skills - Experience of working with and for senior executives - Stakeholder management - Presentation skills - Microsoft Office applications - Basic Financial Understanding - Project management tools and methodologies - Change Management2012-05-18 18:06:17United StatesAmgenCalifornia15609BRCAThousand Oaks, CA28792882http://www.amgen.jobs/xml/28792882/jobUSASan Francisco - Field BasedAuto req 15745BR Job Posting Title Sr Biopharmaceutical Rep, Bone Health - San Francisco, CA Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - California Location (City) San Francisco - Field Based Amgen Job Description Territory #58311 San Francisco, CA Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. As a Sr Biopharmaceutical Rep, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications 2 years of sales and/or marketing experience within pharmaceutical, biotech or healthcare industries Previous experience selling in the osteoporosis market. Expert local knowledge in the primary care or specialty market. Successful launch experience in a highly competitive market. Outstanding business acumen including experience with: Medicare Part B Contracting Managed Care or pull-through Capital equipment or durable medical device sales Proven strategic account management Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve2012-05-17 20:58:43United StatesAmgenCalifornia15745BRCASan Francisco - Field Based, CA28771086http://www.amgen.jobs/xml/28771086/jobUSANoneAuto req 15691BR Job Posting Title Compliance Senior Manager - GCP - Field Based Career Category Compliance Employee Subgroup Salaried FT Country (State/Region) United States - Field Based Location (City) Field Based Amgen Job Description This is a field based position which can be based anywhere near a major US metropolitan area with the preference being the Eastern US. This is an exciting opportunity for a Compliance Senior Manager position with Amgen's Global Compliance Auditing (GCA) team. It is a key GCA position for planning and participating in global audits of Amgen’s clinical trials and pharmacovigilance activities. The position also provides a wide range of compliance advice and may also support regulatory inspections of clinical sites and Amgen facilities. This position is home-based in the US and reports into a Senior Compliance Manager, who manages four other home based staff. The home-based (regional) auditors are part of Amgen’s Global Compliance Auditing department located in Thousand Oaks, Ca. The position requires approximately 40% travel to US and international audit sites. Key responsibilities of the Compliance Senior Manager include: - Plan, conduct and report routine and directed clinical trial and PV compliance audits - Provide GCP and PV compliance advice in line with current best practices - Manage the planning and implementation of compliance programs for specific area of expertise and act as point of contact for this area - Host and/or play a lead role in regulatory authority inspections - Lead GCA process improvement initiatives - Author and contribute to the development of GCA cross-functional controlled documents - Provide coaching / mentoring to staff and provide cross training for staff in area of expertise Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications - Bachelor’s degree in Science - Minimum of 5 years experience in GCP/Pharmacovigilance/auditing - Experience supporting regulatory authority inspections of clinical research and/or pharmacovigilance activities - International auditing experience - Participation in process improvement initiatives - Leadership or mentoring experience - 7 or more years experience in GCP/Pharmacovigilance/auditing KNOWLEDGE - Knowledge of regulations applicable to area of technical expertise - General knowledge of clinical development and PV process and operations - Knowledge of audit/compliance program design and audit methodology KEY COMPETENCIES - Team work - Motivation skills - Leadership skills - Verbal and written communication - Results oriented - Analytical skills - Time management2012-05-17 20:58:35United StatesAmgenNone15691BRNoneVirtual, USA28771082http://www.amgen.jobs/xml/28771082/jobIRLDun LaoghaireAuto req 15464BR Job Posting Title Sr Associate QA Career Category Quality Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Job Description Position Title: QA Snr Associate Reports to: QP Group/Division: Amgen Dun Laoghaire Department: QA Shift Yes 24/5 Position Summary: This job specification outlines the general responsibilities associated with the role of QA Snr Associate at ADL. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role. The QA Snr Associates duties are as follows; • Compiles QC and Manufacturing batch records and reviews for compliance to cGMPs and Product Licenses. • Review and approve Master Batch Records • Review non conformances for completeness • Prepare the agenda for Site Quality Review Team and submits non conformances for review/discussion. • Prepares the SQRT minutes. • Assigns expiry date to products. • Prepare deviation trend reports bi annually to establish any evident trends. • Schedules products to be placed on the stability program • Status changes and yields product on the computer system • Prepares non conformance reports for shipments as required • Tracks CAPA’s detailed in non conformance reports • Writes, reviews and approves Standard Operating Procedures in accordance with Amgen Policies • Prepares Monthly Metrics. • Ensure compliance with Amgen procedures • Performs Quality Audits to ensure compliance with cGMPs • Maintains databases and other informational systems as necessary. • Prepares the KPI reports as required. • Complies with responsibilities as outlined in the site Safety Statement section 3.6. • Performs all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures. • Participates in a learning and development programme which will include goal setting, annual performance reviews and individual development plans. • Is a champion for safe working practices and safety initiatives within their functional area. Basic Qualifications Education: Third level qualification, preferably to degree level, in a Science discipline. Experience: Minimum three years industrial experience or equivalent Preferred Qualifications Knowledge and training in QMTS, SAP, EBR and Maximo Strong organizational skills and ability to manage multiple tasks at one time Ability to follow assignments through to completion and meet timelines Self motivated Strong communication skills (both written and verbal) Demonstrated ability to work as both a team player and independently Ability to evaluate documentation and operations according to company procedures Ability to make decisions independently or elevate to management, as appropriate in an environment that balances business need, quality and compliance risk Strong word processing, database and spreadsheet application skills2012-05-17 20:58:26IrelandAmgenNone15464BRNoneDun Laoghaire, IRL28771078http://www.amgen.jobs/xml/28771078/jobUSAThousand OaksAuto req 15746BR Job Posting Title Specialist IS Bus Sys Analyst Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position will be part of the Information System Global Regulatory Affairs and Safety team within the Development Information system (Dev IS) function and will be responsible for management of the Global Regulatory Affairs and Safety (GRAAS) system solutions. This position will serve as a liaison between Safety business function and Information system team and to provide technical solutions to the GRAAS business function. The primary responsibilities of this position will be to support and drive the following: • Partner with Amgen Safety Globally to translate high-level business requirements into functional specifications for system implementation and configuration. • Communicate and manage the client area expectations in the delivery of solutions. • Develop requirements and design artifacts including architectural components • Develop system testing and validation strategy • Provide technical support to implement application software changes • Manage system maintenance downtime needs between the user community and system support personnel • Partner with IS shared service group to manage the safety platform • Participate in Incident and Problem Management functions for incidents related to safety platform • Liaise with vendors to obtain resolution to technical application issues • Responsible for planning and execution of annual Disaster Recovery exercise for safety platform. • Lead the system upgrade effort including planning, documenting and implementing. • Following Amgen change management process, manage indentified issues/incidents from production system(s), perform root cause analysis and provide appropriate resolution. • Organize and lead meetings of cross functional IS and supplier support groups. Will be expected to develop recommendations and lead the implementation of improvements in documented practices and reports. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications This position requires advanced knowledge and proven skills in administration and management of drug safety systems; a proven record of leading changes and delivering software solutions by working in a highly regulated and service oriented environment; and in depth knowledge and understanding of information system infrastructure. Requires a candidate with experience in all aspects of SDLC from requirements, design, testing, strong business analysis and data analysis. • Experience of working on major programs/projects that involved multiple stakeholders from inception to completion • Knowledge of SDLC and must have experience in a highly regulated environment closely with quality and validation • Strong analytical skills, good at system design and architect • Working knowledge of RDBMS, such as Oracle; advanced experience of writing SQL queries and developing functions/packages with PL/SQL • Knowledge of database and data warehouse modeling • Familiar with change control process; experience of maintaining and supporting systems • Experience with Oracle Argus Suite is preferred. • Good documentation and communication skills • Must be capable of prioritizing tasks and multi-tasking in an environment that can require changing and varied demands from ad hoc reporting to management to engaging development staff at a technical level to resolve issues and meet release schedules. • Demonstrate learning agility • Should be self motivated and a quick learner2012-05-17 20:57:34United StatesAmgenCalifornia15746BRCAThousand Oaks, CA28771039http://www.amgen.jobs/xml/28771039/jobUSASouth San FranciscoAuto req 15588BR Job Posting Title CDM Systems Mgr Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Thousand Oaks Amgen Job Description The CDM Systems Manager will serve as global manager and as a technical team point-of-contact within Electronic Trial Operations (ETO). This role will work with cross-functional Amgen teams of Clinical, Biostatistical, Data Management, Supply Chain, as well as with external representatives. This role will drive the design, implementation and maintenance of outsourced electronic solutions in support of clinical trials. The role will provide the technical oversight required to ensure adherence to study specific requirements, Amgen policies, procedures, standards all within a regulated environment. The position is expected to partner effectively with other CDM System staff to ensure high quality deliverables and to aggressively pursue opportunities to further propagate the use of ETO technology and services. Key Responsibilities include: • Lead study level system requirements meetings with internal and external clients • Design and oversee the development of study specific technical documents • Document possible risk and implement mitigation plans • Manage project related timelines and associated activities • Identify and track study-related technical issues to resolution • Provide a supportive framework for continuous process and quality improvements Other responsibilities include: • Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines. • Provide feedback on clinical protocols as it relates to electronic solutions and ensure the use of data standards and adoption of configurable modules • Procurement and program management of resources, timeline, and services from both internal and external service providers • Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology • Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers • Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives • Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished • Develop strong relationship with external providers (such Vendor Providers) and utilize strong negotiation skills to ensure a delivery of CDM Systems deliverables Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications 5 years of experience implementing clinical systems, such as CTMS, EDC, IVRS, IWRS, ePRO or other related technology in the pharmaceutical/biotechnology industry 3 years of biopharmaceutical clinical research experience Candidate will demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills • Must have sound problem resolution, judgment, and decision-making abilities • Must be able to work well in a global team-based matrix environment with minimal supervision • 6+ or more years of experience in a technical role within clinical data management, clinical development, clinical setting, or IS/IT • Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements • Experience successfully implementing and IVR and IWR systems • Work experience integrating other clinical technologies including but not limited to such technologies such as eClinical, RAVE, EDC or other related technology in the pharmaceutical/biotechnology industry • Experience and ability creating and effectively presenting concepts and materials to senior and executive levels • Working knowledge of Good Clinical Practices and Global Regulatory regulations as applicable • Previous line management experience2012-05-17 20:57:32United StatesAmgenCalifornia15588BRCASouth San Francisco, CA28771038http://www.amgen.jobs/xml/28771038/jobBELField BasedAuto req 15630BR Job Posting Title Product Specialist Oncology Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) Belgium Location (City) Field Based Amgen Job Description Develops and implements territory Plan of action (POA) and key account plans. Achieve/exceeds POA. Evaluates progress vs. plan monthly, and conducts systematic analysis of problems. Anticipates situation in which performance goals may be missed in order to make appropriate adjustments Proactively collaborates with Cluster/Territory Team members to ensure alignment throughout the Territory and agrees on actions regarding specific accounts and key customers Contribute s through constructive feedback Applies knowledge of retail/hospital environment to pre-calls plans by selecting the right message which suits the needs of different stakeholders Responds to competitive threats and opportunities by keeping informed and contributing to competitive intelligence Meets customer expectations in terms of standards of service and addresses services breakdowns in a timely fashion Reports customer activity in the Customer Relation Management (CRM) system and ensures customer profiles are kept up to date Consistently uses Amgen’s Performance 4 selling platform Operates within the agreed expense budget aligned with POA priorities Organizes and manages activities in a timely fashion and follow-up with customers Attends and positively contributes to all relevant training programs. Plays a leading role in cycle meeting s and training events. Demonstrates mastery of objection handling techniques Region: Flemish Brabant, Antwerp South and 3 hospital groups in East Flanders Basic Qualifications Minimum 3 to 5 years of experience in the pharmaceutical industry in a sales-related job Basic knowledge of and experience in a hospital environment Experience with computer systems (CRM databases and MS Office) Fluency in Dutch and English, both in oral and written communication Preferred Qualifications Bachelor’s degree in life science or (bio) medical sciences Knowledge of Customer Relation Management (CRM) principles Exposure to interactions with various disciplines and organizational levels Exposure to project management principles2012-05-16 19:09:00BelgiumAmgenNone15630BRNoneField Based, BEL28737817http://www.amgen.jobs/xml/28737817/jobUSAThousand OaksAuto req 15711BR Job Posting Title Medical Information Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This professional will be responsible for working within Medical Information in the Scientific Affairs organization and will be involved with communicating product information to internal and external customers. This position offers an opportunity to work in a matrix environment on a cross-functional team that is focused on supporting Amgen’s innovative scientific programs. Primary responsibilities include providing verbal and written clinical and technical information to internal and external customers as it relates to Amgen’s inflammation products; facilitating intake and documentation of adverse events and product complaints as they relate to Amgen products; conducting literature reviews and analyses around the potential impact to the business; monitoring and reviewing the literature to identify competitive issues. Additional responsibilities will include developing key deliverables in support of Amgen inflammation products; providing clinical support to other Amgen departments; developing and/or participating in training programs; supporting Amgen customers at major scientific meetings. Key deliverables and activities include the development of medical information letters; development of Clinical FAQs to be used by the MedInfo healthcare professional staff, regional medical liaisons and/or call center representatives; developing key literature surveillance outputs to ensure timely communication of key data across Amgen; and training vendor HCP staff on data and processes. Basic Qualifications ?Doctorate degree OR ?Master’s degree & 3 years of directly related experience OR ?Bachelor’s degree & 5 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience Preferred Qualifications Prior experience in Medical Information / Drug Information is strongly preferred. Two or more years of biotech/pharmaceutical and/or clinical experience are also preferred. Knowledge and understanding of clinical and therapeutic issues relevant to Rheumatology and Dermatology preferred. Strong verbal and written communication skills are required along with the ability to work in a matrix environment, across multiple teams. Proven scientific literature analysis and evaluation skills; organizational and project management skills, technical writing skills; computer literacy; and the ability to manage a large number of complex projects simultaneously.2012-05-16 19:08:46United StatesAmgenCalifornia15711BRCAThousand Oaks, CA28737812http://www.amgen.jobs/xml/28737812/jobUSAThousand OaksAuto req 15349BR Job Posting Title Dir Information Systems (Quality Lab Systems) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Director of Information Systems Quality Lab Systems (within OIS) will be responsible for the successful management and execution of all the IS activities supporting the Quality Control (QC) within the Operations Quality organization. The key focus area will be the leadership and management of our Quality Lab Systems Portfolio, which includes LIMS with Stability Management, LMES (Electronic Notebook) with Consumable Inventory Management, and CDS systems. The person in this role will lead the Corporate Quality Lab IS team that supports the AMGEN QC Network globally. The person will have direct client executive relationship management responsibility with Amgen Corporate QC executive as primary client, as well as site business executives as stakeholders of the delivered systems and solutions. This person will become part of the overall Global OIS Leadership team and will have opportunities to lead strategic issues and/or to help influence corporate/global wide directions within OIS. This position will be based in Thousand Oaks, California and travel at various times is anticipated to be approximately 20% to support globally distributed staff and portfolio execution. Specific Responsibilities are: • The Director will manage a staff of Lab Systems Analyst distributed globally across Amgen locations, in delivery of Lab Systems services utilizing and enhancing the Lab Systems Global Delivery Model and Business Practices. The Lab Systems portfolio spans across both Commercial and Clinical areas and includes a mix of facility expansions, systems upgrades and new construction projects. Oversight responsibilities will include individual project governance with stakeholders and service providers including business case justification, scope, schedule, resourcing, application of technology, reporting as well as portfolio level demand management, resourcing, reporting and prioritization with clients. • This person will be responsible for developing and driving the overall global Quality Lab Systems Project Portfolio, including the governance and budget strategies that can deliver the global portfolio. • This person will also be responsible for developing and driving a global IS Support Model (for day-to-day operations, software product roadmap, and life-cycle management) for the lab systems; one that will leverage the existing Global external partnerships, IS network and staff at each of the major Operations sites. • The candidate must be able to influence the development of business area strategy where appropriate and be expected to partner with key stakeholders to drive the lab systems roadmap and its’ evolution looking ahead to Quality’s strategy. • The individual will develop and chair the Amgen’s Lab Systems network through a cross site and cross functional team setting, and will participate in several Global QC forums representing the voice of Amgen Lab Systems network. • The individual will also manage key strategic supplier relationships from both product and services side as required. • The individual will ensure compliance with Amgen and industry practices, policies, procedures, legal requirements and goals of project sponsors and approved methodologies with supporting documentation and monitoring. • Continuously drive improvement processes & governance for IS in support of QC organization Basic Qualifications • Doctorate degree & 4 years of directly related experience OR •Master’s degree & 8 years of directly related years experience OR •Bachelor’s degree & 10 years of directly related experience • AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Advanced degree in Computer Science, Engineering, Life or Physical Sciences, or Business (MBA) • 12+ years of biopharma experience with 15+ years experience in operations/manufacturing/clinical manufacturing/IS, including cGMP regulated environments • 5 years of supervisory experience with demonstrated skills in staff motivation, coaching/mentoring and professional development. • Experience working cross-functionally and building collaborative working relationships; interfacing effectively with Operations and IS Senior and Executive Management to resolve issues • Excellent communication capabilities vertically and horizontally. • Ability to deal with complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and facilitate decision-making • Certified or experience in process improvement methodologies such as Lean/Six Sigma • Facilitation/ Planning / Negotiation / Coaching & Project Management skills • Results oriented, strong adherence to timelines and ability to maneuver in large corporate setting • Excellent ability to translate knowledge and build high performing teams • Demonstrated working knowledge on automation systems & manufacturing information systems in cGMP regulated environments, FDA cGxP and 21 CFR Part 11 regulations, software development lifecycle and system validation. • Demonstrated working knowledge of enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering. • ERP experience is a plus.2012-05-16 19:08:38United StatesAmgenCalifornia15349BRCAThousand Oaks, CA28737808http://www.amgen.jobs/xml/28737808/jobUSAThousand OaksAuto req 15701BR Job Posting Title Scientist - Analytical Research and Development Career Category Scientific Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Analytical Research and Development (AR&D) organization seeks an outstanding scientist to support our clinical pipeline and commercial activities at our Thousand Oaks, CA facility. Key responsibilities for this incumbent will include the development and application of traditional and novel enabling analytical approaches through the use of, for example, chromatographic, spectroscopic, and solid-state methodology used during, and support of, drug substance/product development and manufacturing. Other responsibilities also include investigating, recommending, developing, and driving the implementation of analytical enabling workflows with automation and information technology. The successful candidate will also participate in and contribute on multi-disciplinary project and technology teams across a matrix organization. Basic Qualifications • Doctorate degree OR • Master’s degree & 6 years of scientific experience OR • Bachelor’s degree & 8 years of scientific experience Preferred Qualifications • Ph.D. degree, or equivalent, in analytical chemistry, chemistry, pharmaceutical sciences, biochemistry, or related field • Excellent written and oral communication skills are required for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment. • Strong abilities in trouble-shooting, problem-solving, data review and interpretation, and multi-tasking • Theoretical and practical understanding and experience in wet chemistry, separation/spectroscopic sciences and associated instrumentation • Understanding of laboratory automation and information technology • Familiarity with drug substance/product development and manufacturing2012-05-16 19:08:01United StatesAmgenCalifornia15701BRCAThousand Oaks, CA28737796http://www.amgen.jobs/xml/28737796/jobUSAThousand OaksAuto req 15705BR Job Posting Title CDM Systems Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Serve as primary point-of-contact to coordinate and lead comprehensive and holistic Clinical Data Management system services to Data Management Therapeutic teams. The Manager of Client System Services – CDM Systems Interface (CSI) role will ensure the proper, timely, and successful setup and implementation of clinical data management services during study startup, study maintenance, and study closeout for individual study teams. The CSI will ensure the most effective use, implementation, and observance of systems and data standardization, and status of CDM System services including but not limited to EDC, clinical trial database programming deliverables, including database, edit check, custom report programming, CDM Systems lab administration, CDM SAS programming deliverables, including data transfer plans, electronic data load, lab range entry, lab data review, IVRS, IWT, and SAS macros and other clinical data management activities according to study startup timelines in a regulatory compliant manner. This position is expected to partner effectively with other CDM System team members to seamlessly ensure high quality deliverables serving as the primary point of contact as a program management function to the systems and technology setup and operations supporting study management activities. The CSI is expected to ensure and support continuous global operations of Amgen’s Data Management operations and systems and work collaboratively with the Thousand Oaks and UK based CDM teams and stakeholders enabling operational effectiveness and utilization. Mentor and support junior staff • Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines. • Procurement and program management of resources, timeline, and services from both internal and external service providers • Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology • Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers • Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives • Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished • Develop strong relationship with external providers (such as FSP and Vendor Provider) and utilize strong negotiation skills to ensure a delivery of CDM Systems deliverables Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • 3+ or more years of experience in a client facing technical role within clinical data management, clinical development, or IS/IT • Successful delivery and track record performing and leading a team in a customer facing mission and representing and ensuring enterprise class technical service delivery • Previous experience working in a global environment • Previous Data Manager in clinical development setting or study team related experience • Superior partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements • Medidata RAVE, Oracle Siebel eClinical, or Oracle Remote Data Capture hands on operational and system knowledge desirable • Work experience implementing other clinical technologies including but not limited to IVRS, IWT, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred • Experience and ability creating and effectively presenting concepts and materials to senior and executive levels • Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary • Knowledge of ITIL v3 and basic Industry IS best practices • Candidates should demonstrate excellent project management and broad technical understanding, attention to detail, and excellent communication and documentation skills • Excellent time management and organization skills required • Must have sound problem resolution, judgment, and decision-making abilities • Must be able to work well in a global team-based matrix environment with minimal supervision • Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable2012-05-16 19:07:37United StatesAmgenCalifornia15705BRCAThousand Oaks, CA28737777http://www.amgen.jobs/xml/28737777/jobUSAThousand OaksAuto req 15677BR Job Posting Title Specialist IS Architect - Unified Communications - Microsoft Lync / Cisco Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Job Summary Service Manager responsible for defining, developing the delivery and the support of the Unified Communication technologies at Amgen. A key deliverable will be developing a long term roadmap for the deployment of Unified Communications (UC) at Amgen. Daily oversight and operations of Amgen’s Unified Communications Services and infrastructure, resolution of escalated Service issues and oversight and guidance of Level 2 support staff. Candidate will operate from Amgen’s Thousand Oaks, California, location. A critical part of the role will be to ensure operational support is defined and implemented in the most effective and efficient manner. Job Responsibilities • Owner of the UC Service delivery strategy • Define and Communicate to staff the UC Service” o Ensure training and education is available and in place. • Responsible for defining, maintaining and roll out of the UC strategy roadmap o Define UC equivalent operational model of existing services o Development and implementation of roadmap for 2012 • Responsible for the delivery and support of the Lync IM and Presence service globally o Define/enhance current operational support model • Responsible for the delivery and support of the UC Enterprise Voice and Conferencing service to existing pilot projects. o Plan for future expansion based on roadmap. o Plan to enhance current operational support model based on expansion • Develop and maintain Service Catalog description of the Service • Communication and promotion of the service to clients to ensure use cases are identified to ensure the service continues to meet client needs • Financial responsibility for Operational/Project budget Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • College Graduate, preferably in Telecommunications, Networking or Computer Sciences • Minimum 10 years experience PBX/VOIP including Nortel and Cisco environments • Management of project teams of 5 or more staff • Delivery of Telecom/VOIP services to 30,000+ environment • Minimum 3 years Microsoft Lync IM and Presence, Video and VOIP experience • Minimum 3 years Unified Communications and collaboration including Lync or Cisco call center manager • Minimum 3 years experience working in Biotechnical, Pharma or related industry • Minimum 5 years experience with call center solutions • Minimum 5 years project management or direct management responsibilities • Strong written and verbal communications skills, including the ability to converse with both technical and non-technical users • Working knowledge of Word, Excel, Outlook, SharePoint, File Maker Pro, Visio and other standard” business software platforms2012-05-16 19:06:30United StatesAmgenCalifornia15677BRCAThousand Oaks, CA28737717http://www.amgen.jobs/xml/28737717/jobUSAThousand OaksAuto req 15721BR Job Posting Title Finance Mgr Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Hybrid position supporting both Partnership and G&A FP&A teams. This role will provide financial oversight, analyses and management reporting of (1) external alliances to forecast partnership revenues and expenses and (2) functions within the G&A organization to forecast operating budgets and headcount. Job functions include, but not limited to the following: Partnership Responsibilities •Work closely with Amgen staff and external representatives to prepare detailed financial modeling and analysis to support strategic planning, negotiations and operational decision making. This includes working with Finance, Accounting, Corporate Development, Alliance Management, Legal, Tax, Treasury and Operations/R&D personnel. •Review and become a content expert for external alliance agreements. Provide guidance when questions arise as to why and how costs are accounted for, billed and forecasted. •Ensure milestones associated with partnerships are planned for and managed appropriately through an existing database tool. •Manage royalty expense and income forecasts via input from Legal and Accounting. G&A Responsibilities •Lead financial expense planning processes such as the monthly Close, Latest Estimates, and annual Planning activities including headcount management. •Prepare, analyze and present operating expense results for various department managers and communicate expense plans and results. •Prepare standard and ad hoc expense analyses including headcount related costs and outside expenses. •Provide client support as needed Basic Qualifications Doctorate degree OR Master’s degree & 3 years of experience directly related to the job OR Bachelor’s degree & 5 years of experience directly related to the job OR Associate’s degree & 10 years of experience directly related to the job OR High school diploma / GED & 12 years of experience directly related to the job Preferred Qualifications -MBA and/or CPA -5+ years experience in Financial Planning & Analysis and/or Accounting -Prior work experience in, and understanding of, pharmaceutical business -Demonstrated leadership capability and team leader/player skills -Strong analytic, organization, problem-solving and communication skills -Working knowledge of Cognos PowerPlay, TM1, GPS and SAP applications. -Excellent Excel and PowerPoint skills2012-05-15 20:55:36United StatesAmgenCalifornia15721BRCAThousand Oaks, CA28712276http://www.amgen.jobs/xml/28712276/jobUSAThousand OaksAuto req 15715BR Job Posting Title Sr Exec Assistant Career Category Administrative Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Reporting to the VP of Oncology Sales, the Senior Executive Assistant (SEA) will be responsible for performing senior level administrative support. The SEA’s administrative and project work assignments will be complex in nature requiring absolute discretion, as well as considerable tact, judgment, creativity and initiative in resolving issues. The SEA must also be able to manage multiple priorities in a continually changing environment. This role will also be responsible for the orderly establishment, maintenance and retrieval of filed information and correspondence, composing and editing correspondence on behalf of the Vice President, maintaining calendars, scheduling appointments and coordinating arrangements for meetings, and coordinating domestic and international travel. Specific responsibilities of this position include helping to organize workflow by reviewing and managing correspondence sent to the executive; screening and directing incoming calls/correspondence/visitors; and answering questions/providing information when appropriate. This SEA will process expense reports, gather data from a variety of sources for inclusion into technical reports and presentations, perform independent research and prepare information for special projects as assigned. Basic Qualifications Associate’s degree & 4 years of experience directly related to the job OR High school diploma / GED & 6 years of experience directly related to the job Preferred Qualifications • Bachelor’s degree • Strong project management experience • Executive assistance experience • Strong technical knowledge and experience especially with Amgen’s internal infrastructures (Microsoft Vista, Sharepoint, SAP, Cognos, IS Online Service Request, Help Desk; Concur/Expense Reporting; Concur Carlson Wagonlit Travel; e-Finity) • Exceptional communication skills – oral and written • Team Player • Honed leadership skills • Outstanding interpersonal skills • Excellent Microsoft suite ability • Excellent time management and project management skills • Innovative, creative, flexible2012-05-15 20:54:13United StatesAmgenCalifornia15715BRCAThousand Oaks, CA28712214http://www.amgen.jobs/xml/28712214/jobUSAField BasedAuto req 15729BR Job Posting Title Sr Biopharmaceutical Rep, Inflammation - Fort Worth, TX Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Texas Location (City) Field Based Amgen Job Description Territory #33707 - Fort Worth covering Arlington, Abilene, Midland, Odessa, San Angelo As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-05-15 20:52:39United StatesAmgenTexas15729BRTXField Based, TX28712130http://www.amgen.jobs/xml/28712130/jobUSAThousand OaksAuto req 15693BR Job Posting Title Health Economics Sr Mgr - Nephrology Career Category Health Economics Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Develops scientific evidence to support global value and access strategies for Amgen products in Nephrology therapeutic area Responsibilities: 1. Develops Global and Regional value propositions 2. Develops economic models (cost effectiveness, budget impact, etc) and conducts analyses of existing data, both independently and in collaboration with vendors and key opinion leaders. 3. Develops annual strategic plans and research projects that support the value proposition including outcomes research, patient reported outcomes, and health economics modeling 4. Creates and maintains the Global Value Dossier 5. Performs health economics projects from inception to completion and publication including creation of Study Concept Documents, Protocols, Analysis Plans, Study Reports, abstracts and manuscripts 6. Reviews and critiques medical and evidence-based outcomes literature 7. Manages researchers and health economics vendors external to the company, including scientific guidance, contracting, and budgets 8. Works with clinical and commercial teams to create and implement payer, value and publication plans, and to provide inputs into clinical development programs including payer endpoints and PROs design and analysis 9. Interacts with and presents to multiple departments within Amgen, both in the US and internationally, including health economics, clinical development, biostatistics, observational research, commercial, brand teams, payer and pricing 10. Builds relationships with Key Researchers and Opinion Leaders Basic Qualifications - Doctorate degree & 2 two years of directly related experience OR - Master’s degree & 6 six years of directly related experience OR - Bachelor’s degree & 8 years of directly related experience Preferred Qualifications - PhD in Health Economics, Epidemiology, Outcomes Research, Health Services Research - 4 or more years of experience in global outcomes research including dossier submissions for reimbursement - 3 or more years of experience developing economic models and conducting observational research e.g. in claims data - 3 or more years of experience in PRO/HRQOL research including questionnaire design, evaluation, and/or analysis - Direct experience in economic modeling, statistical analysis, and observational research2012-05-15 20:52:38United StatesAmgenCalifornia15693BRCAThousand Oaks, CA28712129http://www.amgen.jobs/xml/28712129/jobUSAWest GreenwichAuto req 15708BR Job Posting Title Sr Mgr Information Systems (Automation) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - Rhode Island Location (City) West Greenwich Amgen Job Description The Sr Mgr IS - Automation leads a group of engineers to provide automation technical and engineering support for the 24x7 manufacture of biopharmaceuticals. This individual will define automation strategy and manage the automation team to deliver high quality requirements, design, implementation, commissioning, qualification, operation and maintenance of computer related systems to meet business expectations in a GAMP and cGMP compliant manner. Responsibilities include: - Establishing strategy and direction for automation in support of strategic business needs as it pertains to multiproduct commercial and clinical biopharmaceutical manufacturing. - Providing direct and indirect supervision of full time staff plus supplemental contractors as needed to support project activities. - Working with engineering, process development, manufacturing and quality groups to provide support for the design, installation, start-up, validation and operation of facility and/or process equipment. - Supporting the ongoing enhancement and optimization of automation systems by using a cGMP change management and software development lifecycle approach. - Providing solutions to a wide range of difficult problems by applying industry wide knowledge in the development of automation systems. - Translating strategic business needs into a project methodology framework. - Driving continuous improvement and high reliability performance by building a culture of innovation, organizational learning and zero defect thinking. - Managing non-conformance, corrective and preventive actions for automation systems. - Providing direction and resource prioritization relative to multiple projects, programs and on-going initiatives. - Guiding the successful completion of complex projects by applying extensive technical and managerial expertise in the design, maintenance and alteration of automation systems to meet scope, schedule, quality and management strategic objectives. - Interacting with senior internal and external personnel, often requiring coordination between organizations. - Understanding regulatory trends in industry. Direct experience with FDA or equivalent regulatory body is required. Acts as the primary automation technical lead during internal and external audits. - Providing 7x24 escalation support for major manufacturing automation issues. - Other functions may be assigned. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR •Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience • AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Advanced degree in Engineering or Life Science. • 8+ years of biopharma experience with 5+ years experience in operations/manufacturing, to include cGMP regulated, Delta V process control/automation. • 4+ years of supervisory experience with demonstrated skills in staff motivation, coaching/mentoring and professional development. • Technical expertise with batch process control systems and industry standards, including ISA S88, S95 and GAMP. Familiarity with DCS, MES, BAS and PLC/SCADA systems. • Demonstrated skill in the practical application of Engineering principals and Project Management techniques.2012-05-15 20:52:36United StatesAmgenRhode Island15708BRRIWest Greenwich, RI28712128http://www.amgen.jobs/xml/28712128/jobTURIstanbulAuto req 13822BR Job Posting Title Sr Associate Human Resources Career Category Human Resources Employee Subgroup Salaried FT Country (State/Region) Turkey Location (City) Istanbul Amgen Job Description Ensures job descriptions for all positions are written and agreed with line management and HR Manages the recruitment processes in partnership with line management Conducts HR programs such as orientation, recruiting events, employee relations meetings Coordinates on-boarding, hiring and payroll processess Creates training plan in order to develop employees’ skills Ensures HR programs are communicated and understood by employees Implements international HR policies and procedures Manages day-to-day relationship with external suppliers/vendors Facilitates communication between individuals and departments/business units Supports performance management processes Ensures compliance with local labor laws through review of work contracts and status changes Ensures accurate and compliant pay and benefits administration Conducts annual competitive benchmarking analysis and other HR reports for the site Basic Qualifications University Degree: HR, Business or similar 3 to 5 years of related industry experience Knowledge of recruitment, communication, training process Fluency in English, both in oral and written communication Computer skills Preferred Qualifications Minimum 3 years of experience in HR Experience in multinational pharmaceutical company2012-05-14 18:35:07TurkeyAmgenNone13822BRNoneIstanbul, TUR28674621http://www.amgen.jobs/xml/28674621/jobUSAField BasedAuto req 15659BR Job Posting Title Sr Biopharmaceutical Rep, Oncology - Houston West Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Texas Location (City) Field Based Amgen Job Description Territory:(#17411) Houston West, TX - covering - West Houston from but not including the medical center, Lake Jackson, Pearland, Richmond, Wharton, Katy As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-05-14 18:35:06United StatesAmgenTexas15659BRTXField Based, TX28674620http://www.amgen.jobs/xml/28674620/jobUSAField BasedAuto req 15656BR Job Posting Title Sr Biopharmaceutical Rep, Oncology - San Antonio South Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Texas Location (City) Field Based Amgen Job Description Territory:(#17418) San Antonio South, TX - covering - Brownsville, Laredo, Harlingen, McAllen, Corpus Christi, Victoria, South San Antonio As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-05-14 18:34:44United StatesAmgenTexas15656BRTXField Based, TX28674613http://www.amgen.jobs/xml/28674613/jobCANNoneAuto req 15518BR Job Posting Title Scientist - Biologics Discovery Career Category Scientific Employee Subgroup Salaried FT Country (State/Region) Canada Location (City) Burnaby Amgen Job Description Amgen’s Therapeutic Discovery (TD) organization seeks an experienced and outstanding Scientist to support the Biologics Discovery efforts undertaken at Amgen British Columbia. Amgen’s research facility located in Burnaby, British Columbia, Canada is focussed on the use of XenoMouse technology for the generation and characterization of therapeutic antibody panels. The successful employee will be responsible for providing scientific leadership and participate in the strategic design of the screens used to select best-in-class therapeutic molecules, by leveraging experience in large molecule pharmacodynamics, pharmacokinetics and biophysical interactions. In addition, this scientist will develop and carry out biochemical characterization screens utilizing BiaCore, KinExA, ForteBio and other common platform screening technologies. A core component of this role will be the development of novel and innovative screening methods to interrogate properties of molecules which will aide the selection of the best drug candidate panels. The successful incumbent also will develop high throughput screening, binding assays and innovative platform technologies that enable the selection of best therapeutic drug panel. Other responsibilities will include working locally and cross-site with scientists within other functional areas of the Therapeutic Discovery department and the greater Discovery Research organization to develop therapeutic design goals and recommendations on the best strategy for identifying the molecule of interest. Basic Qualifications • Doctorate degree OR • Master’s degree & 6 years of scientific experience OR • Bachelor’s degree & 8 years of scientific experience Preferred Qualifications • Ph.D. degree, or equivalent, in biochemistry, analytical chemistry, biophysics, pharmaceutical sciences, chemistry, or related field with 3-5 years of postgraduate research experience • Large molecule drug development experience with an emphasis on pharmacokinetics and biophysical interactions. • Theoretical and practical understanding and experience in wet biochemistry, assay development and screening, and associated instrumentation with special skill sets in Biacore, ForteBio and KinExA • Experience with laboratory automation and information technology • Strong abilities in trouble-shooting, problem-solving, data review and interpretation, and multi-tasking • Excellent written and oral communication skills. • Enthusiasm for working in a fast-paced, multi-disciplinary, team-based environment2012-05-14 18:34:21CanadaAmgenNone15518BRNoneVirtual, CAN28674601http://www.amgen.jobs/xml/28674601/jobTURIstanbulAuto req 15170BR Job Posting Title Sr Biopharmaceutical Rep Employee Subgroup Sales Incentive FT Country (State/Region) Turkey Location (City) Istanbul Amgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications2012-05-14 18:33:19TurkeyAmgenNone15170BRNoneIstanbul, TUR28674573http://www.amgen.jobs/xml/28674573/jobUSAThousand OaksAuto req 15682BR Job Posting Title Disbursements Shared Services Manager Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Responsible for the assessment and development of training strategies for Global Expense Report area (Accounts Payable and Payroll) Effectively plan, coordinate and conduct necessary training as required to ensure best in class customer support Responsible for developing and executing client outreach strategies domestically and internationally Successfully manage and cultivate key client relationships to ensure that Staff Expense Management objectives are met in a cost-effective and timely manner Lead effort to translate the needs of key clients into training programs and drive communication in support of projects and other key initiatives Responsible for training documentation and measuring the effectiveness of training through metrics and other tracking methodology Responsible for strategic business partnering with key clients; including participating in work streams for process improvement initiatives Responsible for electronic expense report system implementation; including program communications, training and change management Travel domestically and internationally up to 20% per year Basic Qualifications Doctorate degree OR Master’s degree & 3 years of experience directly related to the job OR Bachelor’s degree & 5 years of experience directly related to the job OR Associate’s degree & 10 years of experience directly related to the job OR High school diploma / GED & 12 years of experience directly related to the job Preferred Qualifications Advanced degree / certification such as Accounts Payable Professional (CAPP), CPA , CMA, MBA is desired 5 years of progressive operational experience in expense reporting, accounts payable, payroll, purchasing, finance, accounting, and / or auditing Experience with ERP systems (SAP) Experience with electronic expense reporting sytems (Concur is preferred) Strong, proven management, leadership, and communication skills (written and oral) Strong presentation skills Advanced public speaking skills Minimum of 2 years leading global project teams Proficient in Microsoft Word, Excel, Power Point Knowledge and understanding of procurement to pay process is desirable Excellent and insightful analytical skills; ability to be decisive, build teams and provide leadership Excellent business acumen (e.g., knowledge of business drivers, finding solutions and knowledge of accounting, finance and other business areas) Advanced skills in Microsoft Visio and Access Multilingual2012-05-14 18:32:14United StatesAmgenCalifornia15682BRCAThousand Oaks, CA28674548http://www.amgen.jobs/xml/28674548/jobUSAThousand OaksAuto req 15570BR Job Posting Title Scientist – Clinical Immunology Career Category Scientific Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Scientist for our Medical Sciences / Clinical Immunology group will be responsible for the design and execution of specific scientific experiments for the development and implementation of methods in cell biology and immunology as supported by flow and imaging cytometry/microscopy platforms. This includes that development and implementation of novel approaches and protocols that are more sensitive, of higher throughput and/or of decreased cost. This includes the ability to conduct data analysis and interpretation, and assess impact of the data on a given projects as well as the ability to provide technical support and expertise to department operating groups when needed. The scientist in this role will represent the group on cross-functional project teams and will have the ability to contribute as lead author on scientific documents such as journal publications, technical reports, etc. Basic Qualifications • Doctorate degree OR • Master’s degree & 6 years of scientific experience OR • Bachelor’s degree & 8 years of scientific experience Preferred Qualifications The ideal candidate should have the following: Qualifications and experience: • PhD in Life Sciences or related field with 2 plus years of relevant laboratory experience • Or, Master's degree in Life Sciences or related field, or Medical Technologist certification (with Bachelor's) with 8 or more years of relevant laboratory experience General Knowledge: • Demonstrated innovation in cell biology, flow or imaging cytometry/microscopy. • The ability to solve complex problems, demonstrating a deep understanding in a scientific area of expertise. • A demonstrated ability to drive scientific excellence and innovation. • Knowledge of the drug development process. • The ability to effectively present scientific information both internally and externally to influence decisions and/or scientific practices. Specialized Knowledge: • In depth knowledge of fluorescence probes as they relate to a multiplexed assay design. • In depth knowledge of at least one pertinent cytometry platform (flow cytometry, high content imaging cytometry, microscopy) and how it may be applied to experiments in the field(s) of Immunology, Hematology, Oncology, Neurology, etc. • The ability to work with cell lines, whole blood and tissue specimens from animals and humans. • Project Management as it pertains to multi-tasking and charting the course to meet timelines. In addition these general competencies are highly desirable: • Ability to communicate complex ideas to audiences with varying degrees of knowledge. • Initiative. • Attention to detail. • Independence of thought demonstrated through hypothesis formulation, experimental design, interpretation and innovation. • Demonstrated critical thinking with an ability to integrate data and information to solve complex problems. • Ability to balance collaboration on a functional and/or cross-functional team as a leader and/or a member against hands-on experimentation in the laboratory.2012-05-14 18:32:09United StatesAmgenCalifornia15570BRCAThousand Oaks, CA28674545http://www.amgen.jobs/xml/28674545/jobTURIstanbulAuto req 15495BR Job Posting Title Training & Development Mgr Career Category Training Employee Subgroup Salaried FT Country (State/Region) Turkey Location (City) Istanbul Amgen Job Description This role is responsible for development, coordination and execution of field training for the BHBU, including New Hire Training, Semester Meeting Training, curriculum review, and ongoing clinical and skill training. Individual will be a liaison with the BHBU Sales and Marketing teams to evaluate and identify training needs based on strategic plan, and develop and implement training to reflect those needs. Individual will work with business unit to effectively develop and deliver training solutions that have universal application. Review and assist with developing and updating training modules, field training curriculum, training exams and role play scenarios. Work with BU and Sales Operations to train on automated customer management system and sales reporting tools. Interface with Sales and Marketing team to understand brand strategy and goals. Responsible for translating national brand plan, and its tactics into training curriculum/content for new hire training execution. Responsible for MAC review of training materials in conjunction with marketing. Prepare, coordinate, and facilitate training with field leadership and guest trainers. Establish training metrics/assessments to measure performance during phase 1 and 2 new hire curriculum and report findings to sales leadership. Develop/facilitate additional POA training as requested by Strategic Training Managers. Interface with Strategic Training Manager group to provide new hire curriculum updates. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of experience directly related to the job OR Bachelor’s degree & 5 years of experience directly related to the job Preferred Qualifications Bachelor’s degree. 3 years of biotech or pharmaceutical selling experience. Ability to travel 50-75% of the time. Documented ability to consistently achieve or exceed sales goals. Demonstrate strong communication, leadership, and presentation/facilitation skills. Able to influence and build cross-matrix relationships. Strong analytical and technical skills, creative problem solving, and excellent oral, written and interpersonal skills.2012-05-14 18:32:00TurkeyAmgenNone15495BRNoneIstanbul, TUR28674543http://www.amgen.jobs/xml/28674543/jobUSASeattleAuto req 15679BR Job Posting Title Sr Associate (Purification) Career Category Process Development Employee Subgroup Hourly FT Country (State/Region) United States - Washington Location (City) Seattle Amgen Job Description The candidate will be a member of the Purification Process Development (PPD) department. Candidate will be part of a technical team involved in product recovery and purification process development of monoclonal antibodies and other proteins. Work will involve bench and pilot scale process and technology development activities in the areas of harvest clarification, chromatography, and/or filtration. Technology transfer to pilot, clinical and commercial manufacturing as well as data documentation will be aspects of this job. Basic Qualifications - Master’s degree, or will have obtained degree by August 2012 OR - Bachelor’s degree & 2 years of directly related experience OR - Associate’s degree & 6 years of directly related experience OR - High school diploma / GED & 8 years of directly related experience Preferred Qualifications - Master’s degree in Biochemistry, Chemical Engineering or scientific field OR - BS in Biochemistry, Chemical Engineering or scientific field and 3+ years in purification process development - Experience in product recovery/clarification, chromatography, filtration, and/or high throughput screening (HTS) technologies - Experience in developing purification processes for clinical and/or commercial manufacturing - Ability to work well in a team environment - Excellence in communication skills – both verbal and written2012-05-13 20:34:33United StatesAmgenWashington15679BRWASeattle, WA28663965http://www.amgen.jobs/xml/28663965/jobCANNoneAuto req 15700BR Job Posting Title Sr Associate Contract Management (Contract) Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) Canada Location (City) Mississauga Amgen Job Description Position: Senior Associate Clinical Contracts & Budgets Reports to: Manager, Clinical Research Services Grade: 4 Starting:August 2012 (13-month maternity-leave contract) Location: Head Office, Mississauga Internal Candidates are required to have a discussion with their current manager regarding intent to apply. Job Purpose: To manage all site-related contracting and budget negotiations and to process and track related payments in a timely and efficient manner. Key Job Functions: 1. Negotiates contract with clinical trial site, responding to comments within defined parameters set (produced by Legal) and seeking legal input for issues outside parameters set 2. Leads the review of the budget template with local project manager for country feedback on FMV (Fair Market Value) and the Schedule A template 3. Negotiates site budget from the base budget and payment milestones using appropriate guidelines 4. Escalates contract/budget issues to Legal, Pricing, and/or local & global study manager as appropriate 5. Coordinates and participates in meetings with site/legal to resolve contract issues 6. Manages, executes and reconciles payments ensuring that spending is within approved contract budgets 7. Maintains contract and payment data tracking in appropriate databases and financial systems 8. Manage internal stakeholder needs and expectations through regular communication regarding progress/status of pending contract and payment requests. 9. Actively contributes to results-oriented global and local departmental goals 10. Identifies opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness Basic Qualifications Qualifications/Experience • Bachelor’s degree in a science or business field • 3-5 years or more related experience in finance administration, project management, contracting or other relevant work experience in life sciences or medically related field • Work experience in clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO is preferred. Competencies • Ability to work independently with little supervision as well as in a team environment • Strong Negotiation skills • Strong analytical and presentation skills • Excellent written and oral communication skills • Attention to detail • Persistent, tactful and persuasive • Proficiency with computer/database systems • Strong organizational skills with the ability to manage multiple priorities2012-05-11 18:20:30CanadaAmgenNone15700BRNoneVirtual, CAN28633380http://www.amgen.jobs/xml/28633380/jobAUSBrisbaneAuto req 15688BR Job Posting Title Sr Biopharmaceutical Rep - Qld North (Bone) Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) Australia Location (City) Brisbane Amgen Job Description Part time (4 days per week) permanent role, based in Queensland, Australia. Territory: Queensland North. Reporting to the National Sales Manager(Bone). Accountabilities: - Maximizes revenue and market share of Amgen’s products in territory and achieves/exceeds sales targets. - Develops and maintains in-depth knowledge of the product, market and stakeholders - Collaborates with manager to implement agreed Plan of Action in line with marketing strategy and works within agreed budgets. - Establishes and manages high quality customer relationships - Establishes and manages effective relationships with territory partners - Proactively collaborate with a team of GP representatives to build an advocacy cascade to primary care through meetings Responsibilities: Territory Analysis & Planning: - Collaborates with manager and territory partners to develop and implement territory Plan of Action and key account plans - Collaborates with relevant stakeholders (Medical /Key Account Manager, Territory Partner, GP team) to agree on key account/primary care plan objectives/responsibilities - Evaluates progress vs. plan monthly, and agrees to course corrections with manager where necessary - Provides feedback to product/sales management on competitor activity Customer Relations and Clinical Selling: - Develops and maintains up-to-date customer/key account/market understanding - Details products in accordance with Amgen’s sales process (Performance 4) and agreed marketing strategy - Continuously develops and improves product knowledge, communication and selling skills through self-learning and active participation in agreed training programs and mentors GP team - Build and maintain long-term associations with physicians and other health care professionals based on trust Organization & Administration: - Proactively Reports customer activity in the CRM system and ensures customer profiles are kept up-to-date - Operates within the agreed expense budget - Follows up on customer queries in a timely manner Collaboration: - Ensures open communication and shares best practices, is in close collaboration with the rest of the team, actively exchanging ideas - Participates in the Amgen Performance Management System (MAP) - Help develop product and disease state knowledge in their GP territory partners to ensure high impact calls in their territories. Basic Qualifications Minimum requirements: - Minimum 3 years GP or Hospital sales experience (or combination of) - Some experience with computer systems (CRM databases and MS Office) - Fluency in English, both in oral and written communication - Relevant local qualifications e.g. Medicines Australia Accreditation - Valid Driver's licence Applicants must be located in and have work rights in Australia to be considered for this position Preferred Qualifications Preferred Requirements: - Science or nursing or business qualifications (Bachelor’s degree) - Basic knowledge of and experience in a hospital environment - Knowledge of Customer Relation Management principles - Exposure to interactions with various disciplines and organizational levels - Exposure to project management principles2012-05-11 18:20:29AustraliaAmgenNone15688BRNoneBrisbane, AUS28633379http://www.amgen.jobs/xml/28633379/jobUSAThousand OaksAuto req 15692BR Job Posting Title Sr Project Manager - IS Application Hosting Services Infrastructure Group Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Senior Project Manager position resides in the Application Hosting Services (AHS) infrastructure group within Amgen and provides an exciting opportunity to work in a leading biotechnology company that uses cutting edge research to discover, develop, manufacture, and deliver innovative human therapeutics. The AHS group is responsible for designing, testing, implementing, and operating the shared infrastructure services for Amgen’s worldwide IS needs across such diverse disciplines as storage, virtualization, private and public clouds, database, datacenter management, operating systems, and data protection. The core responsibility of this position will be to plan, manage, and track major projects that use resources across all the AHS disciplines. In addition, the successful candidate will be working directly with Director and Executive Director leadership in planning effective resourcing directions, cost containment, and efficiency strategies in project management and human resourcing. This position is a senior-level opportunity working in multiple disciplines including the following: program and project management, finance, and technical experience in infrastructure technologies and services. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree or & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Extensive experience in managing a software development and/or infrastructure engineering development lifecycle using both waterfall and agile methodologies and driving, tracking and reporting on multiple projects simultaneously Proven track record tracking complex projects using industry standard project management software such as Microsoft Project Experience designing, deploying, and maintaining project reporting and tracking system(s) using a self-service web portal where project status can be viewed by interested members of the company Proficient level of scripting, software development, or web service development to deploy and maintain a reporting and tracking portal Demonstrated financial experience in budgeting, tracking, and reporting financial status to all levels of management Strong oral and written communication skills, excellent interpersonal skills, and the ability to interact well with multiple levels of management. Understanding of, and experience with, ITIL 3.0 best practices and enterprise change control procedures. Experience working with different forms of project resourcing strategies, such as vendor outsourcing, staff augmentation, SOW creation, FTE hiring, and matching near-term and long-term human resource planning to project load Demonstrated experience planning complex dependencies into simplified timelines and deliverable schedules, managing rapidly changing priorities, and tracking financial status of many simultaneous projects. Ability to effectively communicate status, progress, issues, and roadblocks in a timely and effective manner to technical engineers, client representatives, and senior and C-level executives. Experience rolling up 25-30 simultaneous projects into an on-line reporting and tracking system where project teams, technical leadership, and client teams can visit the portal to find the status of a given project within a two-day reporting window. A consistent track record of delivering complex technical projects on time and to budget is a must for this role.2012-05-11 18:18:23United StatesAmgenCalifornia15692BRCAThousand Oaks, CA28633343http://www.amgen.jobs/xml/28633343/jobUSAThousand OaksAuto req 15191BR Job Posting Title Principal Engineer - Primary Container Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The successful candidate for this position is required to provide hands-on technical leadership to primary container selection and commercialization as it relates to Design for Manufacturability (DFM) . Job responsibilities will be primarily focused on providing expert technical leadership in ensuring that the design of primary containers, and their packaging systems (for aseptic containers) integrate flawlessly with fill finish equipment. This includes expertise in determining critical interfaces of the container design and equipment. • Apply expertise in a fundamental scientific principles to analyze the component design and machinery interfaces both in terms of geometric dimensions and tolerances, forces and kinetics. • Evaluate and solve complex technical issues, design, execute and interpret necessary experiments, lead technology transfers, and address complex process deviations. • Communicate and/or present scientific and technical information within area of expertise to a diverse set of audiences, including project teams, and senior management. • Operate in a highly matrixed environment to collaborate effectively with cross functional teams, critically analyze study protocols, reports and risk assessments, communicate and elevate technical or strategic issues to team members and management as needed, and make recommendations and/or decisions to guide successful execution of process transfers. • Apply fundamental scientific (Mechanical Engineering, Material Sciences, statistics, etc.) to identify and ensure scalable component/equipment systems that can be transferred to high speed production. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Ph.D. in Mechanical Engineering, or Material Science, or related field with 3 + years experience within a regulated industry; experience to include physical characterization of componnets, and experience in developing manufacturing processes from pilot to production scale with an aim for zero preventable defects. . • Experience including optimization of equipment designs, and equipment interactions, statistical design (Six sigma is highly desired), Geometric Dimensions and Tolerances, Kinetic modeling, DOE, and DFM tool sets. • Strong problem solving, trouble shooting, and communication skills are required. • Ability to participate in global cross-functional teams and work effectively in a highly matrixed team environment. • Participate as author for process documentation of primary containers, technical reports. • The candidate must have experience in scaling production processes in a regulated environment.2012-05-11 18:17:19United StatesAmgenCalifornia15191BRCAThousand Oaks, CA28633309http://www.amgen.jobs/xml/28633309/jobUSANoneAuto req 15620BR Job Posting Title Hospital System Mgr - Long Beach/San Diego Academic Orange Territory Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Field Based Location (City) Field Based Amgen Job Description Territory #18713 - Long Beach/San Diego Academic Orange; Territory Covered: University of California, Irvine Medical Center, Long Beach VAMC, Scripps-Green Hospital and Clinics, San Diego VAMC, University of California, San Diego Medical Centers, Naval Regional Medical Center The Hospital System Manager will act as the primary customer contact for demand creation within targeted hospitals through the execution of marketing strategy techniques and promotion of Amgen products as directed by HS District Managers to achieve or exceed sales objectives. Primary customers include physicians, pharmacists, prescribing physician assistants, nurse practitioners, and executive management; and secondary customers include nurses. Employees may also give additional support to buyers and reimbursement coordinators. Specific responsibilities of this position include achieving or exceeding sales targets by executing marketing strategy techniques such as delivering branded sales messages or executing POA through business-to-business selling techniques. This role will also resolve / triage reimbursement issues, maintain and negotiate hospital product contracts Hospital System Managers are also responsible for maintaining and growing executive relationships with key customer base, managing accounts to ensure optimal product formulary access, and influencing positive formulary decisions with key P & T committee members. Additional responsibilities include providing feedback on marketing strategies, developing territory plans with HS District Manager, and implementing approved territory plan and monitor plan executions against targets. Basic Qualifications - Master’s degree & 3 years of directly related experience OR - Bachelor’s degree & 5 years of directly related experience Preferred Qualifications Bachelors or advanced degrees preferred (e.g. MBA, MPH, etc.) - 5+ years of healthcare sales experience, including teaching hospital or health systems (executive level), and/or P & T selling. - Hospital clinic, oncology, nephrology, or rheumatology experience - Injectable experience preferred - Knowledge of territory and reimbursement/managed care experience ideal. - Ability to demonstrate excellent communication skills, mock/detail/presentation skills, and a proven track record selling multiple products in the hospital setting - Ability to develop thought leaders/residents & fellows, and maintain and grow executive relationships (e.g., CEO, CFO, CMO) in health systems - Ability to analyze and interpret hospital economics/financial performance, successfully navigate through health systems reimbursement, and experience with contract negotiation2012-05-11 18:16:58United StatesAmgenNone15620BRNoneVirtual, USA28633302http://www.amgen.jobs/xml/28633302/jobUSAThousand OaksAuto req 15468BR Job Posting Title Clinical Research Medical Director - Oncology - Xgeva Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This Clinical Research Medical Director is responsible for: - Supporting the development, execution and communication of the global scientific/medical evidence plan - Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program - Supporting the development of key scientific external relationships with opinion leaders - Participating and providing clinical input into safety and regulatory interactions Key Activities: - Provide clinical/scientific input during the development and execution of clinical trials - Interpret clinical trial data - Participate in safety assessments - Participate in interactions with regulatory agencies - Author CSRs, publications and regulatory submissions - Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL - Identify new clinical research opportunities - Support in-licensing and out-licensing activities and partner relationships - Support product lifecycle management for new indications as directed by Global Development Leader - Provide clinical content input to: - Regulatory interactions and documents - Safety interactions and documents - Materials to be used in Scientific Affairs - Materials to be used by the Commercial Organization Basic Qualifications - MD - Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Preferred Qualifications - MD plus accredited residency in oncology, board certified or equivalent - Experience in GU Oncology - Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities - Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) - prior oncology clinical research / experience Knowledge - In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale - Familiarity with concepts of clinical research and clinical trial design, including biostatistics - Sound scientific and clinical judgment - Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements - Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication - Demonstrated ability as a medical expert in a complex matrix environment - History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues2012-05-10 18:49:03United StatesAmgenCalifornia15468BRCAThousand Oaks, CA28605679http://www.amgen.jobs/xml/28605679/jobGBRCambridgeAuto req 13698BR Job Posting Title Regulatory Affairs Sr Mgr Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Uxbridge Amgen Job Description Overview: The Regulatory Affairs Senior Manager is responsible for leading regulatory aspects of a product’s development, blending strategic and project delivery; team management and providing subject matter expertise globally. The emerging markets team is responsible for development and implementation of regional regulatory strategies to expedite global development and registration. This includes:- • Interfacing with the Amgen Regional Hubs for specific strategies or activities that impact a specific region. • Managing the execution of regional strategies and regulatory communications and submissions. • Providing expertise on regional regulatory requirements and precedence to interdepartmental teams. Responsibilities: • Lead the international regulatory aspects of a product’s development. • Be responsible for the regional strategy and execution of the preparation of MA and life cycle submissions. • Assemble and provide timely regional regulatory input to Global Development Team (GDT) and other cross-functional project meetings consistent with Global Regulatory Team (GRT) strategy. • Ensuring global and regional strategy can be implemented within constraints of local requirements through coordination of LOC expertise. • Assist GDT to develop study protocols reports and development plans aimed at achieving regulatory approval and product labelling that supports key messages. • Develop proactive relationship with these regulatory authorities. • Providing technical and/or managerial support for the creation review and finalisation of components of CTA and/or Marketing Applications as well as routine regulatory submissions • Troubleshoot and resolve any problems on the critical path to regional registration in concert with global registration strategy. Basic Qualifications • Relevant Bachelor’s degree is essential • In depth practical experience of the drug development process, from early phase to approval, as well as post-marketing experience. • Experience of managing a centralised procedure for regulatory submission. • Scientific expertise and acumen to work with colleagues across disciplines leading the regulatory agency submission process • Direct line management experience • Experience of liaising with relevant regulatory authorities for scientific advice. Preferred Qualifications • Experience gained within a biologics organisation • Second degree or further education/qualifications • Project management expertise2012-05-10 18:48:28United KingdomAmgenNone13698BRNoneCambridge, GBR28605646http://www.amgen.jobs/xml/28605646/jobUSAField BasedAuto req 15652BR Job Posting Title Sr Biopharmaceutical Rep, Oncology - Cincinnati, OH Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Ohio Location (City) Field Based Amgen Job Description Territory#15305, Cincinnati North, which is part of the Indianapolis Blue District; covering - Portsmouth, OH and areas around north Cincinnati, into Indiana, including Richmond, Greensburg, Shelbyville, Connersville and Madison As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-05-10 18:48:24United StatesAmgenOhio15652BROHField Based, OH28605642http://www.amgen.jobs/xml/28605642/jobUSAThousand OaksAuto req 14384BR Job Posting Title Clinical Research Senior Medical Scientist - Oncology Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This Clinical Research Senior Medical Scientist is responsible for: - Supporting the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan - Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program - Participating and providing clinical input into safety and regulatory interactions - Provide clinical/scientific input during the development and execution of clinical trials - Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols) - Interpret clinical trial data - Participate in safety assessments - Review and provide clinical scientific input to TLGs and safety narratives - Review scientific literature - Initiate database analyses to support commercial/clinical objectives - Contribute to the preparation of clinical study reports and regulatory submissions - Participate in interactions with regulatory agencies - Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Clinical Scientists, NAML, or GDL - Identify new clinical research opportunities Basic Qualifications -MD Preferred Qualifications - MD plus accredited residency in oncology, board certified or equivalent - Two (2) or more years of clinical research experience and/or basic science research Knowledge: - Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale - Familiarity with concepts of clinical research and clinical trial design, including biostatistics - Medical knowledge in the relevant therapeutic area - Sound scientific and clinical judgment - Familiarity with regulatory agency organization, guidelines, and practices - Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication - History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues2012-05-10 18:47:06United StatesAmgenCalifornia14384BRCAThousand Oaks, CA28605575http://www.amgen.jobs/xml/28605575/jobUSAWoburnAuto req 15596BR Job Posting Title Sr Validation Engineer Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) United States - Massachusetts Location (City) Woburn Amgen Job Description Under general direction provide the coordination and execution of validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support manufacturing facilities. In addition the candidate will have to have an understanding of how the various pieces of manufacturing equipment operate, and experience in the field of Validation and Engineering. Self motivated individual who can function with minimal directions. Key Responsibilities: • Assist with the administrative and execution of Validation plans and validation protocols for major projects on site (facility, manufacturing processes, equipment, cleaning, and software). • Assist with the validation activities for the expansion project. • Prepare and /or revise validation protocols/procedures as required. • Review and execute qualification and summary reports, write and revise as needed. • Participate in review of manufacturing operational SOPs and maintenance for facility and process. • Assist in troubleshooting, complex or usual problems arising from equipment/system failures. • Ensure continuous validation maintenance for facility and process through change control program. • Analyze validation data, prepare reports, and make recommendations for changes and or/improvements. • Represent department in meetings when required. Other Responsibilities: • Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity. • Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity. • Interface with manufacturing, technical operation and QC group. Basic Qualifications Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications Educational Requirements: Minimum of a BS in Engineering or related technical discipline. Experience and Skill Requirements: • 6-8+ years experience in the validation of biotechnology or pharmaceutical equipment and processes. • Technical understanding of pharmaceutical/biotechnology unit operations. • Strong communication and interpersonal skills • Good knowledge of cGMP requirements and current industry practices • Demonstrate ability to work in a cross-functional team environment • The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules.2012-05-09 20:34:40United StatesAmgenMassachusetts15596BRMAWoburn, MA28581296http://www.amgen.jobs/xml/28581296/jobUSAThousand OaksAuto req 14257BR Job Posting Title Director, Quality Engineering- Drug Delivery Career Category Quality Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The successful Director of Device Quality Engineering will lead and build a dynamic team that supports all new product development across the organization. In this high profile assignment you will lead a team of direct reports (Quality Engineers) responsible for design assurance for new and existing technology. This team is responsible for accurate, independent evaluation of Design History File documentation, Design intent and Design Quality. A key driver of success in this role is to translate design requirements into processes that ensure quality attributes in the design are maintained and are practical for manufacturing. You also will be the Device Quality Project lead on various high profile combination product teams. The candidate will work closely with Device Engineering to facilitate the development of innovative technology in a timely manner. Programs are focused on early development through transition to manufacturing with some sustaining work and will include risk management, reliability and failure analysis, and quality planning. Other responsibilities include independently determining appropriate test, verification and validation parameters to ensure components and products meet specifications requirements. The incumbent should have an understanding of drug product and drug product development requirements. Key Responsibilities: • Plans, conducts and executes design control activities requiring judgment in the independent evaluation, selection and the substantial adaptation of best practice engineering techniques, testing procedures and criteria. • Ensure team works closely with product development engineering and the supplier/contractor team to establish the system design specifications and product requirements. • Ensure team works closely with design, development, quality, regulatory, and the supplier/contractor team to establish and document the master verification and validation plans in conformance with the system design specification and sound testing principles. • Assists in the planning, coordinating and execution of design verification and validation testing to directly support the master verification and validation plans, including any additional activities such as HALT/HASS and IEC 60601-1-x testing, HFE studies, clinical trials and other standardized test methods. • Participates with the engineering team to establish and drive the design FMEA, FMECA and other risk related activities (ISO14971). • Facilitate the achievement of business goals for device reliability, quality, customer satisfaction, cost and safety by identification, development, and accomplishment of key initiatives supporting the business objectives and operational goals for device quality improvements, customer satisfaction, supplier and component initiatives, and safety. • Product reliability design improvements by ongoing research, design and further development of existing products to continuously improve device reliability, quality, and customer satisfaction. Validated product changes with completed documentation that meets or exceeds established guidelines, plus well-documented research/analyses that support decisions and conclusions. • Validation of supplier processes and support of supplier/contractor Quality Agreements. Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience AND • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Advanced degree in an Engineering discipline, or other Engineering/Life Sciences related discipline and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments. • 4 years of Quality managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources and have lead the commercial launch of a medical device. • CQA, CQM, Six Sigma Black Belt preferred. • ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or Certified Auditor credentials (e.g., ISO 13485). • Lean and or Six Sigma Certification. • Previous experience in Quality engineering and commercialization process with drug delivery devices and combination drug/device products is desired • Design assurance experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal). • Familiar with PCB/PCA assembly and fabrication. • Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools • Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected. • Experience with complex, cross-functional development projects. • Experience working with and leading cross-cultural teams. • Proven ability to apply situational leadership concepts across various intra and inter-departmental matters. • Demonstrated time management, decision making, presentation and organization skills. • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines.2012-05-09 20:34:27United StatesAmgenCalifornia14257BRCAThousand Oaks, CA28581281http://www.amgen.jobs/xml/28581281/jobCHEZugAuto req 15674BR Job Posting Title Senior Associate Clinical Operations Management Career Category Clinical Employee Subgroup Invoice Paid FT Country (State/Region) Switzerland Location (City) Zug Amgen Job Description The Sr. Associate, Clinical Operations Management will support Clinical Operations Managers with overseeing operational activities related to planning, executing, and reporting of Phase 3 and 4 Amgen sponsored clinical trials. Main responsibilies include: Contribute to the design and preparation of the draft informed consent template, ensuring Local content is added Assist in the conduct of feasibility assessments for new clinical protocols if required Contribute to the identification and selection of clinical investigators Work with the Clinical Operations Managers (COM’s) and Senior Associate Clinical Operations Management (SACOMs) colleagues to formulate a comprehensive recruitment plan for each new project. Contribute to the development of study specific processes including study communication plans Participate in identifying study related issues, and work with the COM and MCFO to initiate corrective actions when necessary With the study-specific COM, plan and conduct monthly project review meetings in order to update all Managers on study progress, issues and planned resolutions. Participate in local team meetings, task forces and liaise with Global Study Team if required Identifying and reviewing process issues within the clinical development group and recommending improvements when required Accompany CRA in site evaluations, initiations, monitoring and close out if required. Act as back up to COMs when required Coordinate & actively participate at local investigators meetings Review CQA Site audit reports and work in conjunction with FSP staff and Site staff as required to fix issues Partners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs) For studies with sole project management responsibility (eg Phase 4, follow up and extension studies) Basic Qualifications BA/BS/BSc or qualified nurse (RN) Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting) Preferred Qualifications Project management experience in life sciences or medically related field obtained working on clinical trials in a biotech, pharmaceutical or CRO company Operational performance measurement experience International collaboration experience2012-05-09 20:33:38SwitzerlandAmgenNone15674BRNoneZug, CHE28581226http://www.amgen.jobs/xml/28581226/jobUSAThousand OaksAuto req 15650BR Job Posting Title Sr Mgr Biostatistics Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Senior Manager Biostatistics will implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis •Plan and execute statistical contributions to Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications •Complete statistical analysis of multiple studies/projects •Hire, manage and develop statistical staff •Contribute to resource and budget planning •Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings) •Be familiar with statistical policy and strategy at Amgen •Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field •Promote and communicate statistical awareness and the role of the Global Biostatistics department, and may contribute to statistical consultancy, statistical training and expert advice within Global Biostatistics and within Amgen •Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents •Participate in study and systems audits conducted by Amgen CQA and external bodies, and respond to audit questions and findings •May lead and/or participate in change / process improvement initiatives •May participate in external activities (e.g. Industry, academic) Basic Qualifications .Doctorate degree & 2 years of directly related experience OR .Master’s degree & 6 years of directly related experience OR .Bachelor’s degree or & 8 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience AND . 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Minimum 8 years relevant career experience in the pharmaceutical/biotechnology industry, with Bachelor’s degree (MS/MA degree preferred) in Biostatistics, Statistics, Computer Science, Mathematics, Life Sciences, or other relavent scientific subject Strong project planning and management skills - the ability to lead and manage cross-functional projects from concept to completion, being proactive and taking initiative, striking balance between strategic and tactical thinking, the ability to handle complex tasks, and deliver according to agreed timelines Strong verbal and written communication skills - ability to clearly and effectively present information, demonstrate creativity and foresight in anticipating and solving complex project issues Displays personal ownership - a natural innovator who is always looking for opportunities to improve systems or processes Track record of generating new ideas and solutions to business problems, and the vision and tenacity to translate that vision into quantifiable results Takes steps to ensure the ongoing technical development2012-05-08 18:44:22United StatesAmgenCalifornia15650BRCAThousand Oaks, CA28541377http://www.amgen.jobs/xml/28541377/jobUSAThousand OaksAuto req 15592BR Job Posting Title Business Performance Mgr (Finance) Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Business Performance Mgr will be Finance and G&A focused but will also support other functional areas as well. The Manager of Business Performance will respond to project requests from executives and supervise / execute work with high quality results. In doing so s/he will structure the issues and analyses, manage the work, and prepare and present findings. This role will also support business functions by identifying opportunities and risks and developing the strategies to address them. The Manager of Business Performance will be responsible for developing approaches to improve productivity and implement comprehensive change strategies to transform an organization and enable it to adapt to business challenges. This role will interact with a wide range of leadership and staff inside and outside of Amgen (consultants). Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Doctorate or Masters in finance, business, science, and/or technology • 3+ years experience in finance, biotechnology /pharmaceutical, top tier Management Consulting and / or Investment Banking firms • Experience at a top tier Management Consulting Firm • Strong presence with Senior Executives including ability to communicate effectively on a prepared and ad-hoc basis • Experience in financial modeling and budgeting • Strong quantitative and qualitative analytic skills, specifically financial analysis with an emphasis on valuation • Certification in lean and / or Six Sigma • Excellent conceptual problem solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution • Strong leadership skills with a demonstrated ability to influence different styles • Proven experience as a member of a high performing team2012-05-08 18:43:57United StatesAmgenCalifornia15592BRCAThousand Oaks, CA28541363http://www.amgen.jobs/xml/28541363/jobUSAThousand OaksAuto req 15647BR Job Posting Title Scientist (Cell Sciences & Technology) Career Category Process Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position is for an entry level scientist that will be involved in cell culture process development in support of pipeline molecules. The successful candidate will play a key role in leading and supporting various project teams. Aside from process optimization, the work will frequently involve scale-up of bioreactors and transfer of processes to pilot plant and cGMP manufacturing facilities. The individual will also be responsible for advancing process technology and proprietary cell culture medium in order to improve productivity and efficiency, and control desirable product quality. The person will also be expected to play a technical leadership role in the department for various technology development initiatives in the organization. Needs to be very hands-on with all scales of cell culture operation from plate to shake flask to bioreactors. Will often conduct independent research studies and be expected as a self-starter of research projects. Must consistently keep up-to-date of scientific publications in order to incorporate new scientific understanding and technology into development work. This person will also author technical reports and publications on a routine basis. Basic Qualifications - Doctorate degree OR - Master’s degree & 6 years of scientific experience OR - Bachelor’s degree & 8 years of scientific experience Preferred Qualifications - Ph.D. in chemical engineering, biochemical engineering, bioengineering or biochemistry; some experience post Ph.D. in a postdoctoral research or industrial setting is desirable - Must be familiar with mammalian cell culture in the context of process development such as host cell engineering, transfection, stable cell line generation, clone selection, medium development, bioreactor design, optimizing productivity, and characterization using different modes of reactor operation - Knowledge of cellular metabolism and glycosylation, molecular cloning techniques, assay development for understanding cellular mechanisms, and high-throughput cell culture technology are strongly desired - Ability to use various statistical methods to analyze and interpret data is critical. - Need to have strong project management and organizational skills2012-05-08 18:42:31United StatesAmgenCalifornia15647BRCAThousand Oaks, CA28541276http://www.amgen.jobs/xml/28541276/jobUSANoneAuto req 15490BR Job Posting Title Sr Biopharmaceutical Rep, Oncology - Miami, FL Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Field Based Location (City) Field Based Amgen Job Description Sr Biopharmaceutical Rep, Oncology - Miami, FL As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-05-08 18:40:38United StatesAmgenNone15490BRNoneVirtual, USA28541245http://www.amgen.jobs/xml/28541245/jobUSAThousand OaksAuto req 15524BR Job Posting Title Engineering Projects Sr Mgr (IS Project Controls) Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The IS Project Controls Senior Manager will be responsible to handle a broad range of projects executed at multiple locations around the world. The scope of responsibilities span from liaison with corporate management to obtaining project funding, through managing and objectively reporting project status to senior management. Projects typically range in value from a few hundred thousand dollars to multi million dollars. Project complexity ranges from simple hardware replacement to complete business system replacements. The successful candidate will be the IS project control’s Lead, and will interface with all levels of management across functional areas. The individual in this position will report directly to the Executive Director Engineering Project Controls and via dotted line to the Director Information Systems Business Services. The IS Project Controls Senior Manager will be responsible for developing, with the project team, project funding documents, assisting in budget, schedule and change management, cost and schedule risk analysis, cash flow analysis, and developing historical cost data for bench marking purposes. In addition, he/she will review and analyze contractor cost estimates, bids, change orders, invoices, labor rates, physical engineering/construction progress, etc. The IS Project Controls Senior Manager will be responsible for budgeting, tracking and controlling Amgen costs as well as Construction, IS and Automation engineer, vendors and contractor costs. The IS Project Controls Senior Manager will also be responsible for sourcing, onboarding, training, and overseeing all of the contingent workers who are assigned to IS projects. In addition, he/she will also lead the standardization of all project control processes to be used in IS. Functions (Duties/Accountabilities): 1. Assist the Project Manager(s) in developing project strategies 2. Assist in the preparation of Amgen project funding documents 3. Assist in developing strategies and negotiating pricing for scope of work for subcontractors and vendors such as G-Max, unit pricing, time and material, etc. 4. . Reviewing and analyzing Construction, IS and Automation engineers, vendors and contractor bids 5. Evaluate Construction, IS and Automation engineers, vendors and contractors physical progress 6. Develop and monitor project schedules and cash flow 7. Develop Construction, IS and Automation engineering, vendors and construction cost forecasts for remaining work 8. Reviewing, approving Construction, IS and Automation engineers, vendors and contractor buy outs, change orders and invoices 9. Administrating the closeout of contracts and purchase orders. 10.Prepare monthly project status reports for senior management 11 Lead risk analysis reviews for cost estimates, cost forecasts and schedules using applicable software packages. 12. Project controls resource planning for IS 13. Development of common project control standards to be used in IS Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Bachelors Degree in Engineering, Technology or Life Sciences • 8 + years of experience in commercial and/or industrial construction in project controls: i.e. cost control, scheduling and estimating • 5 + years in biotechnology/pharmaceutical industries • Experience in IS systems supporting global/multiple sites • Proficiency in using SAP, CPM Scheduling and @ Risk software • Proven ability to manage and deliver results in a highly fluid, interactive matrix environment • Commercial and/or industrial construction experience could include: strong technical knowledge in construction cost and schedule management. In addition, have strong analytical skills for estimate analysis, bid evaluations, budget monitoring, cash flow analysis, risk analysis and benchmarking project costs. The individual must have a good understanding of all types of estimating from conceptual through definitive construction estimates • Lean Construction, Six Sigma certifications and/or other continuous improvement methods2012-05-08 18:40:38United StatesAmgenCalifornia15524BRCAThousand Oaks, CA28541246http://www.amgen.jobs/xml/28541246/jobAUSSydneyAuto req 15613BR Job Posting Title Associate Congress & Events Career Category Sales & Marketing Operations Employee Subgroup Salaried FT Country (State/Region) Australia Location (City) Sydney Amgen Job Description 11 month full time contract role, based in Sydney, Australia. Reporting to: Senior Associate Congress & Events Accountabilities: - Ensure coordination and organisation of Amgen’s participation (as sponsor, co-sponsor or guest) at third party international congresses and events - Facilitate and oversee full event management services for Amgen owned educational events and staff internal meetings - Ensures an optimal liaison between the different parties (Business Unit stakeholders, external agencies & suppliers) Responsibilities: - Supports the Business Unit (BU) Project Lead in organising participation (i.e sponsorship) at 3rd Party Events, including sponsorship of Healthcare Professionals - Supports the BU Project Lead with end-to-end event management services for Amgen owned educational events - Ensure high quality services in planning and onsite at all congress & events - Complies with and educates others on company policy & procedures as per formal BPPs - Updates, maintains all relevant event, delegate & budget data in StarCite - Communicates with internal stakeholders & agency partners to disseminate all information relevant to Congress & Events, providing clear guidance on service requirements aligned with Amgen policies & procedures - Monitors and meets deadlines (e.g. invoices, purchase orders, promotional materials, payments to Healthcare Professionals, etc) - Organises and attends site inspections, where appropriate - Facilitate and/or coordinate supplier agreements(e.g., venues, restaurants, exhibition hire, agencies etc) - Organises and follows-up on tenders in order to select the appropriate agency - Liaise with European Congress Team to provide updates on Australian affiliate attendance at Congresses - Manages each event within agreed budget Basic Qualifications Minimum requirements: - High School Certificate - Minimum 2 – 3 years of related meetings & event industry experience - Knowledge and experience with Medicine’s Australia Code of Conduct - Knowledge of travel and tourism industry - Fluency in English, both verbally and written - Experience with MS Office programs Applicants must be based in Australia, with relevant work rights, to be considered for this position. Preferred Qualifications Preferred qualifications: - Degree in Business or Marketing - Basic knowledge of Marketing and Finance procedures - Experience in the pharmaceutical industry - Experience in Hotel administration or Hospitality industry - Experience with StarCite2012-05-07 18:07:34AustraliaAmgenNone15613BRNoneSydney, AUS28478117http://www.amgen.jobs/xml/28478117/jobUSAField BasedAuto req 15646BR Job Posting Title Hospital System Mgr - Columbus, OH Academic Blue Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Ohio Location (City) Field Based Amgen Job Description Territory #15702 Columbus, OH covering Columbus, OH The Hospital System Manager will act as the primary customer contact for demand creation within targeted hospitals through the execution of marketing strategy techniques and promotion of Amgen products as directed by HS District Managers to achieve or exceed sales objectives. Primary customers include physicians, pharmacists, prescribing physician assistants, nurse practitioners, and executive management; and secondary customers include nurses. Employees may also give additional support to buyers and reimbursement coordinators. Specific responsibilities of this position include achieving or exceeding sales targets by executing marketing strategy techniques such as delivering branded sales messages or executing POA through business-to-business selling techniques. This role will also resolve / triage reimbursement issues, maintain and negotiate hospital product contracts Hospital System Managers are also responsible for maintaining and growing executive relationships with key customer base, managing accounts to ensure optimal product formulary access, and influencing positive formulary decisions with key P & T committee members. Additional responsibilities include providing feedback on marketing strategies, developing territory plans with HS District Manager, and implementing approved territory plan and monitor plan executions against targets. Basic Qualifications - Master’s degree & 3 years of directly related experience OR - Bachelor’s degree & 5 years of directly related experience Preferred Qualifications Bachelors or advanced degrees preferred (e.g. MBA, MPH, etc.) - 5+ years of healthcare sales experience, including teaching hospital or health systems (executive level), and/or P & T selling. - Hospital clinic, oncology, nephrology, or rheumatology experience - Injectable experience preferred - Knowledge of territory and reimbursement/managed care experience ideal. - Ability to demonstrate excellent communication skills, mock/detail/presentation skills, and a proven track record selling multiple products in the hospital setting - Ability to develop thought leaders/residents & fellows, and maintain and grow executive relationships (e.g., CEO, CFO, CMO) in health systems - Ability to analyze and interpret hospital economics/financial performance, successfully navigate through health systems reimbursement, and experience with contract negotiation2012-05-07 18:07:30United StatesAmgenOhio15646BROHField Based, OH28478116http://www.amgen.jobs/xml/28478116/jobUSAThousand OaksAuto req 15649BR Job Posting Title Clinical Research Medical Dir Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Clinical Research Medical Director (Biosimilars) is responsible for: • Supporting the development, execution and communication of the global clinical plan • Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program • Participating and providing clinical input into safety and regulatory interactions • Supporting the development of key scientific external relationships with opinion leaders Key Activities • Provide clinical/scientific input during the development and execution of clinical trials • Interpret clinical trial data • Participate in safety assessments • Participate in interactions with regulatory agencies • Author regulatory submissions and publications • Develop key opinion leaders and make scientific presentations • Support in-licensing and partner relationships • Support product lifecycle management Basic Qualifications • MD with clinical experience in Oncology • Three (3) or more years of clinical research experience in biotechnology/pharmaceutical industry or CRO company Preferred Qualifications • MD plus accredited residency in Oncology, board certified or equivalent • Five (5) or more years of clinical research experience in biotech/pharma/CRO company and basic science research combined with clinical teaching or patient care activities • Experience in all phases of clinical research (Phase 1-4) • Experience interacting with FDA and international regulatory agencies • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale • Familiarity with concepts of clinical research and clinical trial design, including biostatistics • Sound scientific and clinical judgment • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication • Demonstrated ability as a medical expert in a complex matrix environment • History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues2012-05-07 18:07:01United StatesAmgenCalifornia15649BRCAThousand Oaks, CA28478115http://www.amgen.jobs/xml/28478115/jobUSASeattleAuto req 15553BR Job Posting Title Specialist IS Analyst - Data Center Infrastructure Lead Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California United States - Washington Location (City) Seattle Thousand Oaks Amgen Job Description The Data Center Operations Lead position resides in the Application Hosting Services (AHS) group within Amgen. This role can be based at either Amgen's Thousand Oaks, California headquarters or at Amgen's site in Seattle, Washington. This position is both a strategic-leadership position as well as an operational excellence position in providing direction in Amgen’s future data center strategy as well as supporting and improving our current global data center footprint. This position requires a qualified candidate to be up-to-date in all data center best practices, technologies, and environmental directions. The primary responsibilities of this position will be to support and drive Amgen’s future data center center directions, provide leadership in financial and technical analysis for both strategic and operational directions, manage daily operations and lead datacenter team, support SOX and GxP audits, and provide data center best practices for Amgen’s worldwide data center infrastructure. The following highlights some of the functions of this position: • Leading data center designs for any new builds, upgrades or retrofits, migrations, and interfacing with facilities or other data center experts as needed. • Lead the development of Standard Operating Procedures (SOPs), Manuals (MANs), Standards (STNDs) and other documented processes for data center processes. • Reviewing, enhancing, and improving the monitoring of power, cooling, space and other capacity metrics and managing appropriate capacity reports. • Support, coordination, planning and/or oversight of data center shutdown and startup efforts and other data center related maintenance activities. • Maintain data center drawings using CAD tools, and manage / track all physical assets in the data center management tool. • Assist with and/or provide direct support of SOX reporting in regards to data center access, including the collection and organization of associated supporting objective evidence. • Plan for and provide 24x7 on-call datacenter access to support production system issues. • Work with IS staff across the functional areas to facilitate process and tool changes, align execution standards, and communicate changes. • Analyze and report on incident trends, process adherence, service performance and metrics. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelor’s degree plus five or more years of data center infrastructure experience. Extensive data center domain knowledge and/or five (5) or more years experience in supporting and/or managing Data Center Facilities in a corporate enterprise environment. One or more vendor certifications and/or training and competencies (AutoCAD, AFCOM, ACM, ITIL) and/or one or more vendor certifications or training (Uptime Institute, IDCP). Strong oral and written communication skills, excellent interpersonal skills, and the ability to interact well with multiple levels of management. Demonstrated experience leading project planning, deployment, and lifecycle management for datacenter projects and managing competing priorities and time constraints to meet business objectives. The ability to perform financial analysis and manage appropriate budgetary items. Understanding of, and experience with, ITIL 3.0 best practices and enterprise change control procedures. Experience running facilities in a highly regulated environment. High skill level of standard tools—Microsoft Excel, Word, and PowerPoint.2012-05-07 18:06:51United StatesAmgenCalifornia15553BRCASeattle, CA28478114http://www.amgen.jobs/xml/28478114/jobUSAField BasedAuto req 15608BR Job Posting Title Sr Biopharmaceutical Rep, Bone Health - Cleveland, TN Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Tennessee Location (City) Field Based Amgen Job Description Territory –#53214, Cleveland, TN covering; Cleveland, W Knoxville, Oak Ridge Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. As a Sr Biopharmaceutical Rep, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Basic Qualifications Bachelor’s degree & 2 years of directly related experience OR - Associate’s degree & 6 years of directly related experience OR - High school diploma / GED & 8 years of directly related experience Preferred Qualifications 2+ years of sales and/or marketing experience within pharmaceutical, biotech or healthcare industries - Previous experience selling in the osteoporosis market. - Expert local knowledge in the primary care or specialty market. - Successful launch experience in a highly competitive market. - Outstanding business acumen including experience with: - Medicare Part B - Contracting - Managed Care or pull-through - Capital equipment or durable medical device sales - Proven strategic account management Core Competencies: - Planning and Organizing Work - Engaging Others Through Effective Communication - Drive to Achieve2012-05-07 18:05:32United StatesAmgenTennessee15608BRTNField Based, TN28478107http://www.amgen.jobs/xml/28478107/jobUSAThousand OaksAuto req 15618BR Job Posting Title Epidemiology Sr Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Observational research (OR) makes important contributions to drug development and commercialization along with randomized clinical trials. OR contributes evidence regarding the frequency and distribution of disease or the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, cost and utilization patterns, and the safety and effectiveness of interventions. In the current environment, there is increasing demand for information from OR studies by regulatory and reimbursement authorities. The Center for Observational Research (CfOR) has been created to address this imperative. Job Summary The OR Sr. Manager is a major contributor within one of the CfOR Therapeutic Areas (Oncology, Bone, Cardio/Renal, General Medicine & Inflammation) and reports directly to a Product Lead. This position will be located at Amgen's Thousand Oaks headquarters. An OR Sr. Manager is recognized as a strong scientific contributor and is a first or contributing author for papers in peer reviewed journals or for internal reports that enhance the company’s mission. Key Activities Include • Contributes to research strategy within the product team and observational research TA • Responsible for conducting high-quality observational research to support product strategy within TA • Executes safety-related analyses/studies • Provides support for safety surveillance across the life cycle of Amgen products • Support preparation of PSRM materials • Executes process of patient exposure estimation for marketed products • Supports development of risk management plans • Plans and conducts database analyses to answer key questions with the product teams • Collaborates with Health Economics colleagues to generate evidence to support the value plan • Participates in cross-functional teams to develop the research strategy for products and conducts the observational research • Supports relationships with key leaders in observational research • Sets annual product-specific and personal goals • Provides input into observational research department meetings • Stays abreast of the latest developments in the field of observational research and drug development and contributes to the field • Promotes observational research awareness • Promotes understanding and use of state of the art observational research methods • Communicates significant scientific information to a variety of audiences Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Preferred Qualifications • PhD degree in Epidemiology or Medical degree with observational research experience • 6 or more years experience in observational research • Record of publications in peer-reviewed journals • 3 years experience with Medical or Doctoral degree • Experience in the design, execution, and analysis of observational research studies within Pharmaceutical or Public Health setting • Experience in research to support drug development • Experience in observational research project planning and management • Experience communicating observational research information (written and oral) • Experience working in multi-disciplinary teams • Managerial experience Knowledgeable in • Basic observational research study designs and analysis • Programming in SAS or other software (e.g. STATA) • Literature search methods • Observational research methodology and applications within Drug Development • Drug development process and operations • Observational research databases • Knowledge of adverse drug experience data2012-05-07 18:05:15United StatesAmgenCalifornia15618BRCAThousand Oaks, CA28478106http://www.amgen.jobs/xml/28478106/jobUSAField BasedAuto req 15619BR Job Posting Title Sr Biopharmaceutical Rep, Oncology - Portland, OR Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Oregon Location (City) Field Based Amgen Job Description Territory (#18104) Portland, OR; Covering - Portland, Salem, Longview, OR As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-05-06 18:16:30United StatesAmgenOregon15619BRORField Based, OR28470538http://www.amgen.jobs/xml/28470538/jobUSASeattleAuto req 15522BR Job Posting Title Research Operations Sr Mgr Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California United States - Washington Location (City) Seattle Thousand Oaks Amgen Job Description Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. The Research Operations Sr. Manager position involves project, portfolio and budget management responsibilities in addition to providing Chief of Staff support to the Therapeutic Area (TA) head and Senior Management team. The Research Operations Sr. Manager will be required to provide portfolio management support to the Research TA by tracking go/no-go decision points for all department projects and working with Sr. Management to outline department strategy and ensure implementation across teams. This employee will participate in departmental alignment meetings with executive staff and is responsible for recording and distributing strategies to internal business partners. This includes responsibility for departmental tracking of FTE (full-time equivalent) allocation and internal portfolio prioritization exercises for resource allocation purposes. The Research Operations Sr. Manager will ensure seamless communication flow between diverse groups, assist with issue resolution and escalation, and ensure timely information transfer between sites and functional areas. The Research Operations Sr. Manager is also responsible for department logistics including the planning and execution of department Capital, Collaborator and Travel Budgets; ensuring department compliance of company-wide initiatives and organization of department retreats, poster sessions and all-staff meetings. This position will also serve as the Chief of Staff to the TA Head and will execute projects as requested. This employee may be required to provide project management support to early stage cross-functional cross-site research project teams. Duties will include assisting with team formation, creation of team strategy and goals, monitoring project status, documenting team meetings through agendas and minutes, and providing follow up to action items generated at either process team meetings or other relevant meetings. The Research Operations Sr. Manager will ensure seamless communication flow between diverse groups, assist with issue resolution and escalation, and ensure timely information transfer between sites and functional areas. The Inflammation TA is a cross-site organization, so travel to alternate sites will be required. This role can be filled in either Thousand Oaks, Ca or Seattle, WA. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications The ideal candidate will have minimum of a BS with 8 plus years of related experience in the biotechnology field. An advanced degree is helpful. The ability to be proactive and independently understand, follow and implement complex instructions is crucial. Strong organizational and proven project management skills are extremely desirable. This employee should be able to manage multiple tasks at one time and to work effectively with teams using strong interpersonal skills. Working in a collaborative and cross-functional environment will make excellent verbal and written communication expertise essential. Strong attention to detail, including the ability to proofread and reformat documents will be vital. Evidence of computer literacy required, specifically advanced word processing, spreadsheet and/or database application, and Power Point.2012-05-06 18:16:10United StatesAmgenCalifornia15522BRCASeattle, CA28470523http://www.amgen.jobs/xml/28470523/jobUSAThousand OaksAuto req 15528BR Job Posting Title Principal Scientist - Cardiovascular Discovery Research Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. A new position is available in the Department of Metabolic Disorders at Amgen. The Amgen cardiovascular research group in Metabolic Disorders is looking for a highly motivated principal scientist with experience in biopharmaceutical discovery research and/or academic basic research to join them in their R&D facility in Thousand Oaks, CA. The successful candidate will have the primary responsibility of leading a large animal cardiovascular physiology laboratory, focusing on models of heart failure and arrhythmias. This individual must have strong technical skills in such models, and the candidate’s primary responsibility will be hands on implementation and critical interpretation of experiments required to assess compound efficacy using state of the art techniques and methods. The successful candidate must also possess the communication/managerial skills along with the level of expertise such needed to teach relevant techniques to less experienced colleagues and reports. The successful candidate will need to work effectively in a fast-paced environment, have the ability to multi-task and work effectively with multiple groups (internal and external to Amgen), have strong oral and written communication skills, and be self-motivated. This position will report directly to the Executive Director of the Cardiovascular Discovery Research Group at Amgen. Basic Qualifications Doctorate degree & 5 years of scientific experience OR Master’s degree & 12 years of scientific experience OR Bachelor’s degree & 15 years of scientific experience Preferred Qualifications The ideal candidate will have an MD or PhD in a scientific discipline, e.g,. physiology or pharmacology. A minimum of 5 to 10 years or more industrial experience in cardiovascular physiology using models of disease to interrogate the efficacy of therapeutic agents. Hands-on experience with canine models of heart failure and arrhythmias in support of early and late stage preclinical drug discovery projects is highly desirable. The ideal candidate will specifically have hands-on experience with cardiovascular imaging techniques (e.g. echocardiography) and invasive assessment of cardiovascular hemodynamics in large animals. The ideal candidate will also have excellent communication and teaching skills required to head a small group of scientists working interactively within a highly matrixed research environment.2012-05-04 19:32:51United StatesAmgenCalifornia15528BRCAThousand Oaks, CA28441231http://www.amgen.jobs/xml/28441231/jobUSAThousand OaksAuto req 15520BR Job Posting Title Regulatory Affairs Director (Policy, Biosimilars) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description GRAAS Biosimilar Policy is accountable for defining Amgen positions on the scientific, medical and regulatory aspects of biosimilars and advocating those standards to external policy makers while concurrently providing key internal subject-matter expertise to cross-functional executive leadership and teams. Job Summary: - Develop, direct and deliver strategic regulatory plans that are in-line with regulatory and business needs - Develop innovative solutions to complex problems through in-depth analysis, coordination and negotiation with subject-matter experts and key decision makers - Work in partnership with cross-functional teams and Amgen leadership to develop regulatory plans that support the direction of the business - Influence a broad spectrum of internal and external stakeholders toward achieving regulatory and business goals - Develop mutually beneficial strategic alliances with internal and external subject matter experts and external key decision makers - Engage in direct advocacy with national, regional and global policy makers and regulators - Represent Amgen and the innovator industry in policy testimony and on trade association key issue teams This position could be located in Thousand Oaks California, or Washington D.C. Basic Qualifications - Doctorate degree and 4 years of directly related experience OR - Master's degree and 8 years of directly related experience OR - Bachelor's degree and 10 years of directly related experience Preferred Qualifications Knowledge and Skills - Science background - Experience in regulatory or clinical development, ideally with biologics - Understanding of national a d global healthcare system, including payers - Critical thinker, able to analyze and critique data - Intellectually creative, able to assess a situation from multiple perspectives - Skilled and credible advocate with experience in 1:1 engagement, large audiences, panel debates - Able to form and defend a position under challenge2012-05-04 19:32:33United StatesAmgenCalifornia15520BRCAThousand Oaks, CA28441221http://www.amgen.jobs/xml/28441221/jobUSAThousand OaksAuto req 15571BR Job Posting Title Regulatory Affairs Director (CMC Lead) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Biosimilars are an important new development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies furthers the Amgen mission to serve patients. Quality biosimilar developments requires integrating all of the analytical science and quality manufacturing experience at Amgen to creatively and rapidly demonstrate comparability to originator products. To facilitate the process and efficient global registrations of the Amgen biosimilar portfolio, the Director for CMC Regulatory Affairs, Biosimilars, will lead the development and execution of regulatory CMC and analytical similarity strategies. Job Summary: - Facilitate product development and global registration of the Amgen biosimilar portfolio by developing and executing regulatory CMC and analytical similarity strategies - Facilitate effective global regulatory agency interactions for product manufacturing and quality programs - Define and execute long-term global CMC regulatory plans for licensed biosimilar products Responsibilities include: Regulatory Strategy and Filing - Provide expertise and leadership in the development, communication, and implementation of global CMC and analytical similarity regulatory strategies in support of biosimilar goals and product portfolio execution - Lead cross-functional teams in development and submission of CMC, quality, and analytical similarity regulatory documents - Accountable for generation and submission of CMC and quality regulatory documents, including CTAs, MAs, and RTQs, are developed with high quality, delivered in a timely manner, consistent with the overall biosimilar strategies, and compliant with current regulatory authority requirements - Ensure product licenses are maintained per regulatory requirements and consistent with biosimilar strategy and long-term planning - Support development and execution of clinical/ non-clinical strategies Regulatory Interactions - Plan, execute and lead agency CMC meetings per regulatory strategy - Facilitate ad hoc CMC-related interactions, RTQ responses and meetings - Represent the Biosimilars Operating Unit in the coordination and conduct of prior-approval and GMP inspections by regulatory authorities Regulatory CMC - Design, plan and execute regulatory CMC strategies - Scientific oversight of development and delivery of analytical similarity regulatory packages that meet biosimilar regulatory requirements - Delivery of CMC information in regulatory documents (including CTAs, MAs, analytical similarity assessments, requests for information, CMC related agency interactions) - Represent RA CMC on appropriate teams - Manage priorities and resources for multiple products Regulatory Intelligence - Monitor, assess and implement regional regulatory requirements - Assess impact of regulatory decisions for competitive products - Generate and communicate biosimilar intelligence to the Biosimilars Operating Unit and Amgen innovative teams as appropriate Biosimilars Policy - Provide subject matter expertise to GRAAS Biosimilar Policy function Collaboration - Support vendor oversight and management for regulatory CMC operations - Exchange biosimilar CMC and analytical similarity regulatory requirements with regulatory colleagues on an ongoing basis Basic Qualifications - Doctorate degree & 4 years of directly related experience OR - Master’s degree & 8 years of directly related years OR - Bachelor’s degree & 10 years of directly related experience Preferred Qualifications -4+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources - Experience in the biosimilars/ biotechnology industry - Experience in interacting with regulatory agencies - Regulatory submissions experience - Experience interacting with senior regulatory agency representatives - Knowledge of global regulations - Familiarity in working with policies, procedures and SOPs - Understanding of drug development - Industry experience in manufacturing, process development, and testing (QC/QA) - Experience in analytical similarity or comparability assessments and development of associated packages - Leadership experience in a functional environment - Comprehensive understanding of Regulatory functional activities and how they affect projects and processes - Global regulatory experience with product filings - Experience interacting and communicating with senior executives and teams regarding strategic issues to ensure expectations are understood - Experience communicating and clearly presenting strategic and business issues - Experience leading teams and projects in a global, complex, dynamic, regulated matrix environment - CMC-specific and analytical-specific regulatory knowledge and experience - Ability to understand and communicate scientific and clinical information - Ability to anticipate and prevent potential issues - Ability to manage and mentor others - Cultural awareness and sensitivity to achieve results across different regions2012-05-04 19:30:47United StatesAmgenCalifornia15571BRCAThousand Oaks, CA28441117http://www.amgen.jobs/xml/28441117/jobDEUField BasedAuto req 15587BR Job Posting Title Mitarbeiter/in wiss. Außendienst Häm/Onk-Gebiet Kassel, Göttingen, Braunschweig Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) Germany Location (City) Field Based Amgen Job Description Mitarbeiter im wissenschaftlichen Außendienst Hämatologie/Onkologie (m/w) Gebiet: Kassel, Göttingen, Goslar, Salzgitter, Braunschweig, Wolfsburg, Hildesheim, Hameln, Detmold, Paderborn Die Stelle ist zunächst befristet für 2 Jahre zu besetzen • Sachkundige und umsichtige Beratung und Betreuung von Meinungsbildnern in Kliniken und Praxen in der Hämatologie/Onkologie mit dem Ziel, die vereinbarten Umsatzziele im Gebiet zu erreichen • Darstellung des Nutzens unserer Produkte für Patienten und Mediziner auf der Basis wissenschaftlich belegter Daten/Studien • Umsetzung wissenschaftlicher Erkenntnisse in verkäuferische Resultate • Enge Zusammenarbeit mit den Teamkollegen und den Spezialisten aus Key Account- und Produktmanagement Der Mitarbeiter berichtet an den regionalen Außendienstleiter Hem/Onc, Team Mitte. Basic Qualifications Fachlich: • Naturwissenschaftliches Studium wünschenswert, evtl. adäquate Ausbildung • 3 bis 4 Jahre Berufserfahrung als Pharmareferent oder Pharmaberater im Spezialaußendienst • Vertriebsorientierte Ausbildung mit Berufserfahrung in kompetitiven Märkten und Erfahrung im wissenschaftlichen Außendienst • Idealerweise Kenntnisse in der Hämatologie/Onkologie • Gute Englischkenntnisse Persönlich: • Marketing- und vertriebsorientierte Denk- und Arbeitsweise • Sicheres und gewandtes Auftreten, Überzeugungsfähigkeit, Akzeptanz bei anspruchsvollen Gesprächspartnern • Ausgeprägte Kommunikations- und Teamfähigkeit • Reisebereitschaft und Pioniergeist2012-05-03 18:03:35GermanyAmgenNone15587BRNoneField Based, DEU28403742http://www.amgen.jobs/xml/28403742/jobCANNoneAuto req 15574BR Job Posting Title Co-op Student: Hybridoma Subcloning and ESN Generation Career Category College Job Employee Subgroup Co-Op FT Salaried Country (State/Region) Canada Location (City) Burnaby Amgen Job Description Amgen British Columbia Inc., one of several research facilities operated by Amgen Inc., specializes in the discovery and development of human therapeutic antibodies. The research center, located in Burnaby, became part of Amgen with Amgen’s acquisition of Abgenix, Inc. in April 2006. It employs approximately 65 people, including research scientists and a small support staff. Amgen is headquartered in the United States and has more than 17,000 staff members worldwide. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing novel medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. This project involves the discovery of novel human therapeutics or diagnostics using XenoMax™ and Hybridoma technology. These two technologies allow identification of single immune cells from a large population that produces very high affinity antigen specific monoclonal antibodies. Another key component of the company is the Xenomouse™, which is a proprietary transgenic mouse capable of producing fully human antibodies. The marriage of these technologies allows us to produce human antibodies against targets that would normally be considered self”. The candidate will be working in the Cell Biology/Subcloning group, which is responsible for using a FACs ARIA single cell sorter to isolate hybridoma’s of interest. Hybridoma’s are then scaled up and used to generate ESN supernatant, which will contain antibody of interest for further assays. The candidate will be responsible for reagent generation, maintenance of both FACS Caliburs and Aria, use of FACsAria for single cell sorting, cell culture, cell banking and harvesting of supernatants. The candidate will also be involved with our Robotics liquid handling platforms to aid in the above work. Anticipated Achievements: • Learn and implement basic cell culture techniques such as sterile technique, splitting cells, optimizing growth conditions, cryovial preservation of mammalian cells, media preparation for various cell lines • Gain experience in both FACS Calibur and Aria systems as well as Robotics • Gain much valuable experience in time organization and multitasking. • Become proficient in background searches and internet research. • Independently carry out projects depending on needs of company All candidates will be subject to the verification of current college enrollment as well as a Canadian criminal records check prior to employment. Amgen retains the right to add or change the duties of the position at any time. As an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the workplace Basic Qualifications • Must be in the process of earning a Bachelors of Science degree in Chemistry, Molecular Biology, Biochemistry, Biology/Microbiology, Life Sciences, Chemical Engineering, or related discipline. • Must be able to work for two consecutive four month terms with continued employment for the second term dependant on a positive performance review at the end of the first term. • Must be NSERC eligible . Amgen requires that all individuals applying for an internship or a co-op assignment at Amgen must meet the following criteria: • Must be 18 years or older • Must be a current full time student • Must have completed at least one full year of study • Must have not yet graduated • Must be in good academic standing within their majors and overall at their university • Must be enrolled in school the fall season following the potential internship or co-op assignment • Must not be employed at the time the internship starts Preferred Qualifications • Prefer students with previous lab experience. • Prior experience in tissue culture is desired, experience in immunology and immunofluorescence techniques would be preferred. • General knowledge of immunology & molecular biology would be an asset. • Excellent organizational skills and attention to detail. • Function effectively as part of a team.2012-05-03 18:02:03CanadaAmgenNone15574BRNoneVirtual, CAN28403685http://www.amgen.jobs/xml/28403685/jobUSASeattleAuto req 15562BR Job Posting Title Sr Associate Biostatistical Programming Career Category Clinical Employee Subgroup Hourly FT Country (State/Region) United States - California United States - Washington Location (City) Seattle South San Francisco Thousand Oaks Amgen Job Description Position can be filled in Thousand Oaks, CA, San Francisco, CA or Seattle, WA •Assist in the review of key study-related documents produced by other functions, e.g. case report form, data management plan, NONMEM specifications •Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications •Understand and execute department-, product- and study-level macros and utilities •Write, test and validate product- and study-level macros and utilities •Assist with study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings •Provide input to and participate in intra-departmental and GBDS meetings •Contribute to the continuous improvement of Global Biomedical Data Sciences (GBDS) and programming •Assist in the review of GBDS policies, standard operating procedures and other controlled documents •Provide support to and mentor more junior programmers •Interface with outsourcing partners and vendors •Attend external professional organizations, conferences, training and/or meetings Knowledge •Computer programming, preferably SAS or other procedural languages •Fundamentals of Project Planning and Management •Drug Development Process & Operations Basic Qualifications •BS/BSc in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject •Three (3) years relevant career experience Preferred Qualifications •MS degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject •Drug Development (pre-, early, late and/or observational) in related industries or academic research •Four (4) years relevant career experience2012-05-03 18:01:32United StatesAmgenCalifornia15562BRCASeattle, CA28403680http://www.amgen.jobs/xml/28403680/jobCANNoneAuto req 15576BR Job Posting Title Co-op Student: Cell Based Screening & Assay Development Career Category College Job Employee Subgroup Co-Op FT Salaried Country (State/Region) Canada Location (City) Burnaby Amgen Job Description Amgen British Columbia, one of Burnaby’s premier biotechnology companies, is focused on the development and commercialization of therapeutic antibody products targeting disease prevention and treatment. The company's antibody technology platform enables the rapid generation and selection of high affinity, fully human antibody product candidates to essentially any disease target appropriate for antibody therapy. Working in partnership with our U.S. based parent company, Amgen Inc., Amgen British Columbia leverages its leading technology, flexible manufacturing capabilities and a network of partnerships for the discovery, development and manufacture of therapeutic antibodies for serious health conditions. For more information, please visit our website at www.amgen.com. Job Summary: The student will be part of a high-energy, fast paced team responsible for cell screening and assay development in our antibody generation process. The team utilizes Flow Cytometry and FMAT as the screening platforms and also utilizes high capacity liquid handling robotics. In addition to becoming proficient in our screening platforms and process, the student is expected to maintain a variety of cell lines and is responsible for cell transfections. The student will have the opportunity to develop novel assays to assist in characterizing lead antibodies. Essential Functions: • Performs a variety of Cell-based assays: • assays used to characterize the immune response in immunized animals • high-throughput cell screens to identify antigen specific antibodies • functional assays to characterize antibodies for epitope specificity, ligand blocking and species reactivity • Gain strong working knowledge of Flow Cytometry, FMAT and ELISA • Critically evaluate data and present results to the team • Tissue culture and transfections • Optimize/develop assays All candidates will be subject to the verification of current college enrollment as well as a Canadian criminal records check prior to employment. Amgen retains the right to add or change the duties of the position at any time. As an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the workplace Basic Qualifications • Must be in the process of earning a Bachelors of Science degree in Chemistry, Molecular Biology, Biochemistry, Biology/Microbiology, Life Sciences, Chemical Engineering, or related discipline. • Must be able to work for two consecutive four month terms with continued employment for the second term dependant on a positive performance review at the end of the first term. • Must be NSERC eligible. Amgen requires that all individuals applying for an internship or a co-op assignment at Amgen must meet the following criteria: • Must be 18 years or older • Must be a current full time student • Must have completed at least one full year of study • Must have not yet graduated • Must be in good academic standing within their majors and overall at their university • Must be enrolled in school the fall season following the potential internship or co-op assignment • Must not be employed at the time the internship starts Preferred Qualifications • Prefer students with previous lab experience. • General knowledge of immunology & molecular biology would be an asset. • Excellent organizational skills and attention to detail. • Function effectively as part of a team.2012-05-03 18:01:15CanadaAmgenNone15576BRNoneVirtual, CAN28403677http://www.amgen.jobs/xml/28403677/jobCANNoneAuto req 15575BR Job Posting Title Co-op Student: In Vivo Career Category College Job Employee Subgroup Co-Op FT Salaried Country (State/Region) Canada Location (City) Burnaby Amgen Job Description Amgen British Columbia, one of several research facilities operated by Amgen Inc., specializes in the discovery and development of human therapeutic antibodies. The research center, located in Burnaby, became part of Amgen with Amgen’s acquisition of Abgenix, Inc. in April 2006. It employs approximately 50 people, including research scientists and a small support staff. Amgen is headquartered in the United States and has more than 17,000 staff members worldwide. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing novel medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. Job Summary The successful candidate will work as part of the Preclinical group at Amgen British Columbia Inc. The student will be responsible for performing a variety of in vivo and in vitro cell biology techniques used to evaluate potential cancer targets and oncology drug candidates. Experiments will be conducted in a semi-independent fashion under supervision. There are a variety of projects currently ongoing in the Preclinical group and these projects change frequently. The student will be involved in some or all of these projects as needed. Essential Functions The job involves assisting researchers in all aspects of in vivo and in vitro studies. There will be some routine aseptic cell culture and flow cytometry. In addition, depending on current projects student may learn some or all of the following: In vivo studies: study design, data collection, treatment formulation prep, animal handling, tumor measurement and data analysis. In Vitro studies: ELISA, SDS-PAGE, Western Blots and cell-based assays evaluating cytokine release, T cell or NK cell activation, proliferation or apoptosis. All candidates will be subject to the verification of current college enrollment as well as a Canadian criminal records check prior to employment. We request that all applicants include a cover letter with their resume when they apply. Applicants without a cover letter may not be considered for the position. Amgen retains the right to add or change the duties of the position at any time. As an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the workplace Basic Qualifications • Must be in the process of earning a Bachelors of Science degree in Chemistry, Molecular Biology, Biochemistry, Biology/Microbiology, Life Sciences, Chemical Engineering, or related discipline. • Must be able to work for two consecutive four month terms with continued employment for the second term dependant on a positive performance review at the end of the first term. • Must be NSERC eligible . Amgen requires that all individuals applying for an internship or a co-op assignment at Amgen must meet the following criteria: • Must be 18 years or older • Must be a current full time student • Must have completed at least one full year of study • Must have not yet graduated • Must be in good academic standing within their majors and overall at their university • Must be enrolled in school the fall season following the potential internship or co-op assignment • Must not be employed at the time the internship starts Preferred Qualifications • Suitable for a first or second work term as all training will be provided. • General knowledge of In Vivo studies, immunology & molecular biology would be an asset. • High attention to detail and able to comply with written procedures. • Strong written and oral communications skills in English. • Excellent organizational skills. • Function effectively as part of a team.2012-05-03 18:01:04CanadaAmgenNone15575BRNoneVirtual, CAN28403671http://www.amgen.jobs/xml/28403671/jobUSAThousand OaksAuto req 15517BR Job Posting Title Principal Engineer - Drug Product Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This is a high level position for a subject matter expert within the Drug Product Engineering Organization. They will be responsible for providing scientific and technical leadership and strategic direction to process development of small molecule dosage forms. They will drive development and implementation of key organizational business processes including QbD approach, GMP expectation and process development by interacting with internal, pharmaceutics, quality and regulatory functions. This is a high visibility technical/leadership position within a growing team. Specific responsibilities are described below • Perform process development, characterization and scale-up for late phase drug candidates • Define manufacturing process and its control strategy • Support design, execution and review of process performance qualification runs at commercial manufacturing site • Perform process monitoring, trending and improvement for commercial drug products • Support GMP productions • Draft relevant CMC sections in marketing applications and/or annual updates • Enable project progression by cross-functional collaboration and documentation of study results/findings into reports • Serve as technical expertise and consultation for internal and external manufacturing sites • Develop process analytical technology (PAT) applications applications Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications The ideal candidate will have extensive experience in process characterization, scale-up, technology transfer, validation, and CMC preparation of pharmaceutical dosage forms to support product filing and launch. The primary focus is oral dosage forms. Experienced in injectable dosage forms is a big plus. Success in this role is strongly dependent upon the individual's ability to effectively communicate and collaborate with team members and/or external partners (e.g., CMO). The candidate should have a collaborative mindset and strong leadership/communication skills for sharing insights and best practice and diligently focus on accomplishing scheduled assignments in a timely manner. The talented individual we seek will demonstrate a thorough understanding of dosage form development, regulatory & quality considerations, and possess hands-on experience with processing equipment. Qualifications should include: • Advanced degree in Biochemical Engineering, Biotechnology, or Pharmaceutical Sciences and 8 years relevant work experience in process/formulation development of pharmaceutical dosage forms • Knowledge of the drug development process • Leadership experience of progressively increased scope. • Strong interdisciplinary project management skills. • Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects. • Should have strong communication skills, both written and oral. • Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans. • Team leadership, management, and facilitation skills are required.2012-05-02 18:26:35United StatesAmgenCalifornia15517BRCAThousand Oaks, CA28331570http://www.amgen.jobs/xml/28331570/jobUSAThousand OaksAuto req 15569BR Job Posting Title Clinical Research Sr Medical Scientist - Nephrology Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Clinical Research Senior Medical Scientist is responsible for: - Supporting the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan - Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program - Participating and providing clinical input into safety and regulatory interactions - Provide clinical/scientific input during the development and execution of clinical trials - Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols) - Interpret clinical trial data - Participate in safety assessments - Review and provide clinical scientific input to TLGs and safety narratives - Review scientific literature - Initiate database analyses to support commercial/clinical objectives - Contribute to the preparation of clinical study reports and regulatory submissions - Participate in interactions with regulatory agencies - Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Clinical Scientists, NAML, or GDL - Identify new clinical research opportunities Basic Qualifications - MD Preferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent - Two (2) or more years of clinical research experience and/or basic science research Knowledge: - Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale - Familiarity with concepts of clinical research and clinical trial design, including biostatistics - Medical knowledge in the relevant therapeutic area - Sound scientific and clinical judgment - Familiarity with regulatory agency organization, guidelines, and practices - Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication - History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues2012-05-02 18:26:35United StatesAmgenCalifornia15569BRCAThousand Oaks, CA28331569http://www.amgen.jobs/xml/28331569/jobUSAThousand OaksAuto req 15510BR Job Posting Title Global Safety Sr Medical Scientist Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role provides content and technical support to the GST in the evaluation of safety data and production of GST deliverables under the supervision of the Global Safety Officer (GSO). Due to significant experience in the role from a scientific and technical perspective this role requires increased independence and leadership with less direct supervision of content driven activities by the GSO. The incumbent must be able to serve as GSO delegate for internal and potentially external Amgen meetings (Data Monitoring Committee, Ad-com representation). Key Activities: Support Global Safety Officer (GSO) in the clinical interpretation of safety signals and evaluations of aggregate safety data including analytical strategy and search methodology Responsible for producing presentations for Product Safety Review Meetings (PSRM) and other scientific presentations under the guidance of the GSO Contribute content support to the development of strategy and creation of product risk management plans, safety updates, safety assessment reports, and other GST deliverables Safety content and expertise in support of Investigator Meetings, Data Monitoring Committees and DRTs, responses to regulatory authorities, safety sections of clinical trial documents Basic Qualifications MD or DO degree from an accredited medical school Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications Advanced Education in Hematology strongly preferred. Current registered medical license Board certified or Board eligible Accredited fellowship or clinical experience Clinical experience, including training Drug safety experience2012-05-02 18:26:31United StatesAmgenCalifornia15510BRCAThousand Oaks, CA28331567http://www.amgen.jobs/xml/28331567/jobUSAThousand OaksAuto req 15390BR Job Posting Title Sr Regional Medical Liaison Career Category Medical Affairs Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position is a field-based position for the Bone therapeutic area Regional Medical Liaison (RML) group within the Scientific Affairs organization. The territory covers Idaho, Montana, Utah, and Colorado. The Senior Regional Medical Liaison (Sr RML) will interact with osteoporosis healthcare decision makers to communicate and advance the scientific platform as aligned with Amgen's corporate goals and objectives. The Sr RML is an integral position in assuring accurate, clear and valued information regarding our science and products to multiple levels within the medical community. The successful Sr RML will communicate complex cutting edge scientific information and research concepts to healthcare decision makers including but not limited to those at Academic Medical Centers. The role may also include providing clinical and economic value information to payers and formulary decision makers. The Senior RML is also responsible for identifying and training members of Amgen's speakers’ bureau to ensure they are updated on new data. In addition, the Senior RML will provide feedback based on field interactions and scientific support consistent with Amgen research and product support. The Sr RML will: • Interact with healthcare thought leaders to communicate and advance the scientific platform as aligned with Amgen’s corporate goals and objectives • Communicate complex cutting edge, scientific information and research concepts to healthcare decision makers, including but not limited to, those at Academic Medical Centers • Provide clinical and economic value information to payers and formulary decision makers • Train members of Amgen’s speakers’ bureau and ensure they are updated on new data • Support Amgen sponsored research • Provide feedback based on field interactions with healthcare thought leaders • Provide scientific support, consistent with the RML compliance standards, for sales, corporate account, and other matrix colleagues’ facilitated HCP inquiries • Foster scientific relationships between Amgen and fellows in training • Lead and/or participate on committees or project teams that support RML strategies and tactics as delegated by RML leadership • Seek out opportunities to support the RML value proposition and achieve results and set an example for others to follow by consistently demonstrating Amgen Values and Leadership Attributes. • Demonstrate tact and organizational savvy when communicating and interacting with others The Sr RML will model openness and innovation through words, actions, and decisions. Amgen RMLs share learning including entrepreneurial and innovative ideas with others and hold self accountable for performance as well as encouraging others to achieve and be accountable for performance. Basic Qualifications Doctorate degree & 2 years of directly related experience Preferred Qualifications 7 or more years of experience in a medically related field, including 1 or more years focused on clinical practice, clinical research, or medical research. Experience in a medically related field can include post doctoral training (i.e., residencies and/or fellowships). 3 + years in a medical science liaison role in a biotech or pharmaceutical company Current Amgen experience in Scientific Affairs or Medical Affairs experience at a biotech or pharmaceutical company Osteoporosis and /or metabolic bone therapeutic expertise area knowledge2012-05-02 18:26:30United StatesAmgenCalifornia15390BRCAThousand Oaks, CA28331566http://www.amgen.jobs/xml/28331566/jobUSAWest GreenwichAuto req 15543BR Job Posting Title Sr Mgr Supply Chain Career Category Supply Chain Employee Subgroup Salaried FT Country (State/Region) United States - Rhode Island Location (City) West Greenwich Amgen Job Description The Senior Manager of Supply Chain will be responsible for the successful management of the Supply Chain team including bulk drug substance end to end Supply Chain activities, including site strategic planning, production planning and raw material procurement. Responsibilities include: • Ownership of site production planning, including coordination, communication, key assumption development and scenario planning • Continuously drive improvement in Supply Chain process • Actively monitor and mitigate supply related risks, including external and internal influences • Successfully lead and build the Supply Chain team • Create strong partnerships with corporate counterparts and global stakeholders Position Specific Tasks: Strategic Influence • Independently determines planning approach to managing daily operations, guided by Amgen policies and management guidance • Develops and communicates plans/objectives to team • Contributes to site and functional strategy • Ensures consistent practices across network • Delivers results through professional employees • Develops and monitors Department budgets and goals • Provides guidance and technical direction to team and site • Institutes standards for Supply Chain management and Strategic Planning Relationship Focus • Develops relationships with cross-functional/network at various management levels to resolve issues and optimize overall Supply Chain • Takes accountability of the day-to-day Supply Chain operations • Partners with Operational Excellence leaders to ensure alignment on commercialization and tech transfer processes • Partners with TA Heads, GOLs, ED Ops Improvement, Corporate Alliance Management to ensure alignment on key cross-functional/product processes and communication Leads Supply Chain Function • Provides people/performance management, coaching and mentoring of staff • Directs staff on strategic and tactical content/approach • Builds, maintain, and retain successful team • Elevates issues in a timely manner • Focuses on Operational Excellence as a means of driving continuous improvement Basic Qualifications Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree or and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Bachelor’s degree in business, engineering, life or physical sciences; • Advanced degree in science, engineering, or business (MBA). • Skills and experience to include: o Demonstrates the Amgen’s Values o Excellent interpersonal skills o Exceptional ability to work cross-functionally and build collaborative working relationships o Strong communication and presentation skills (verbal & written) ; ability to interface effectively with Ops Senior and Executive Management to resolve issues o Excellent communication capabilities vertically and horizontally; ability to leverage contact network to enable cross-functional collaboration; ability to influence o Comfort with complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and facilitate decision-making o Certified or experience in process improvement methodologies such as Lean/Six Sigma o Planning / negotiation / coaching & project management skills o Results oriented, strong adherence to timelines o Excellent ability to translate knowledge and build high performing teams o Strong analytical and problem solving skills o Self-leadership & motivation2012-05-01 18:59:14United StatesAmgenRhode Island15543BRRIWest Greenwich, RI28303394http://www.amgen.jobs/xml/28303394/jobGBRCambridgeAuto req 15496BR Job Posting Title Regional Account Manager - Oncology - East & West Midlands Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United Kingdom Location (City) Cambridge Field Based Uxbridge Amgen Job Description Purpose: Diagnosing requirements and assuming responsibility for evaluating, developing and commercialising external opportunities and minimising threats at a local level in line with Amgen strategy. Ensuring optimal usage of our current and future portfolio. Plans, organises and executes activities to ensure access to funding and sales of our products to meet regional and national goals. Basic Qualifications Accountabilities: Conducts analysis and assessment of accounts to ensure an understanding of issues, key opinion leaders, stakeholders, health priorities, PCT Commissioning, procurement activities, SHAs and/or regional networks. Conducts an analysis of brand strategies to ensure account plans are aligned and prioritised. Profiles and validates key customers. Inputs into the prioritisation of customers to refine segmentation plan. Works effectively with market research and HE team to assess market opportunity. Produces a plan of action to ensure achievement of account priorities and regional and national brand strategy. Involves key internal stakeholders in preparation of account plans to ensure alignment and prioritisation of activities. Supports identification of opinion leaders and develops engagement plan Ensures all activities agreed within the account plans are implemented to completion within time, cost, compliance and quality constraints. Managed Entry – work with payers prior to the launch of new products to ensure an optimum environment. Translates national plan to develop regional plan of action. Develops metrics for success and tracks progress relative to targets. Market Access – ensure an optimum environment for the prescribing of Amgen products both current and future Service Development/Implementation – Accelerate the development and implementation of high quality local services and ensure that all patients who could benefit from Amgen products can gain access to licensed products Maintains effective collaboration within own and cross-functional teams to ensure alignment, progress updates and knowledge share. All role activities completed to meet team/Amgen standard operating procedures and quality standards. Completes all administration and reporting requirements, e.g. CRM, and ensure compliance with Amgen record retention policy. Preferred Qualifications Preferred Qualifications Essential - Extensive experience of working the wider health economy ie, PCT’s, SHA and Cancer Networks in order to make funding available for both new and in line products. - Proven hospital only sales experience - A proven track record of consistently high performance in a hospital sales environment - Experience of working in a primary care (PCO) environment2012-05-01 18:58:34United KingdomAmgenNone15496BRNoneCambridge, GBR28303386http://www.amgen.jobs/xml/28303386/jobUSAThousand OaksAuto req 15447BR Job Posting Title Senior Manager Information Systems Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Senior Manager Information Systems will work in the Engineering Information Systems department within Operations IS (OIS), supporting the Global Engineering function under Operations. He or she will lead a team of IS professionals with overall responsibilities of IS service ownership to implement and support Engineering business systems & solutions that achieve business objectives & strategy, meet user and regulatory requirements, and adhere to approved IS standards and procedures. The candidate will demonstrate an understanding of the functional area business models, processes, and priorities, and leverage that knowledge in the delivery of production support and enhancement of existing systems and the implementation of new IS solutions. He or she will participate in and/or facilitate cross-functional and cross site team meetings to discuss and optimize business process automation and will present key findings to Information Systems and business management. He or she will coordinate the efforts of other Information Systems groups in the delivery of support for the assigned functional areas. Responsibilities include Client relationship management, Portfolio and project management, developing, supporting, and maintaining business & IS Strategy, client service request management, process and systems analysis, requirements elicitation, articulating system solutions and approaches for addressing business needs, and developing and presenting business cases for proposed solutions. Strong emphasis on 'As Is' process and systems mapping, 'To Be' visioning, and identifying and articulating business and IS functional gaps, and Project Management and execution. Responsible for coordinating and working with Amgen IS Shared services groups & supply chain, and external service providers and business partners in support of Engineering IS systems and project portfolio, services optimization, managing service level agreements, internal IS and client coordination, service monitoring and reporting as well as user interface. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Bachelor's degree in Information Systems, Computer Science, Engineering, Business Administration or the Life Sciences 10+ years of related experience, preferably in the biotechnology or pharmaceutical industries 5+ years of experience managing staff; demonstrated ability to build and lead teams in a staff as well as matrix environment; experience leading large, cross-functional initiatives Strong leadership, communication, project management, analysis, customer service, change management and interpersonal skills Knowledge of and experience in applying mainstream IS concepts, technologies, and methodologies Demonstrated strong process and business analysis skills Excellent verbal, written, interpersonal communication, and presentation skills, including the ability to set managerial context for complex issues Demonstrated ability to facilitate the utilization of IS resources within and between multiple IS organizations to meet business objectives Experience with FDA regulations governing computer system validation and operation Experience in supporting Engineering IS systems covering the following business processes: Maintenance Management, Document/Drawing Management, Capital Planning, Capital Project Management and Controls, Facility Management, Calibration Management, and Global Metrics and reporting Professional certifications related to quality, project management, and/or IT service management, and/or membership in a related professional organization such as ISPE, ISA, PMI, or ASQ Knowledge of the SDLC methodologies including Unified Modeling Language (UML), Rational Unified Process (RUP) Demonstrated disciplined Project Management in IS setting Practical experience in performing audits or supporting regulatory inspections Experience working in a regulated industry, preferably pharmaceutical industry Knowledge and experience in applying FDA cGxP and ISPE GAMP guidance Professional certifications related to quality, project management, and/or IT service management2012-05-01 18:56:06United StatesAmgenCalifornia15447BRCAThousand Oaks, CA28303299http://www.amgen.jobs/xml/28303299/jobUSAThousand OaksAuto req 14383BR Job Posting Title Clinical Research Medical Director - Vectibix Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Clinical Research Medical Director is responsible for: - Supporting the development, execution and communication of the global scientific/medical evidence plan - Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program - Supporting the development of key scientific external relationships with opinion leaders - Participating and providing clinical input into safety and regulatory interactions Key Activities: - Provide clinical/scientific input during the development and execution of clinical trials - Interpret clinical trial data - Participate in safety assessments - Participate in interactions with regulatory agencies - Author CSRs, publications and regulatory submissions - Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL - Identify new clinical research opportunities - Support in-licensing and out-licensing activities and partner relationships - Support product lifecycle management for new indications as directed by Global Development Leader - Provide clinical content input to: - Regulatory interactions and documents - Safety interactions and documents - Materials to be used in Scientific Affairs - Materials to be used by the Commercial Organization Basic Qualifications - MD - Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Preferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent - Experience in Oncology - Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities - Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) - prior oncology clinical research / experience Knowledge - In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale - Familiarity with concepts of clinical research and clinical trial design, including biostatistics - Sound scientific and clinical judgment - Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements - Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication - Demonstrated ability as a medical expert in a complex matrix environment - History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues2012-04-30 18:51:03United StatesAmgenCalifornia14383BRCAThousand Oaks, CA28273713http://www.amgen.jobs/xml/28273713/jobUSAThousand OaksAuto req 15534BR Job Posting Title Regulatory Affairs Mgr (Scientific Writer) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The purpose of this group is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans. Job Summary: - Draft scientific, CMC, and regulatory documents that conform to global regulatory requirements, Amgen and industry standards, and accepted templates. - Manage review and approval of scientific, CMC, and regulatory documents; engage members of cross-functional teams to address and resolve issues in accordance with established timelines. - Ensure the accuracy, adequacy, and consistency of documents. - Provide writing expertise to project teams. Key Activities: - Write Scientific, CMC, and Regulatory Documents - Independently write documents in support of product registrations and global filings, eg, briefing documents, responses to regulators’ questions, and Quality-related sections of INDs, CTAs, Analytical Packages, and CTDs. - Participate in the development of study timelines for regulatory documents. - Implement quality control for review and finalization of documents. - Ensure finalized documents are filed and archived appropriately. - Assist with process development initiatives to meet internal needs. - Maintain Writing Expertise and Awareness of Regulatory Environment - Seek opportunities to continue developing writing and editorial skills. - Keep abreast of regulatory requirements that affect work projects. - Collaborate with multidisciplinary teams across global regions. - Negotiate final content and format of dossiers. - Represent Biosimilars Regulatory Affairs on committees, as requested Basic Qualifications - Doctorate degree OR - Master’s degree and 3 years of directly related experience OR - Bachelor’s degree and 5 years of directly related experience OR - Associate’s degree and 10 years of directly related experience OR - High school diploma / GED and 12 years of directly related experience Preferred Qualifications - Degree in Life Sciences or related field - Experience in the biosimilars/ biotechnology industry - Regulatory submissions experience - Regulatory knowledge of global regulations - Working with policies, procedures, and SOPs - Understanding of drug development Knowledge and Skills - Ability to analyze data, and to collaborate with subject matter experts outside one’s own areas of scientific expertise. - Good knowledge and experience with time management and timeline development. - Ability to work with remote workers. - Attention to detail. - Flexibility. - Strong oral and written communication skills. - Ability to understand and communicate scientific and CMC information. - Ability to discern areas of potential concern and communicate concerns effectively to manager. - Cultural awareness and sensitivity to achieve results across different regions.2012-04-30 18:51:01United StatesAmgenCalifornia15534BRCAThousand Oaks, CA28273711http://www.amgen.jobs/xml/28273711/jobUSAField BasedAuto req 15527BR Job Posting Title Mgr District Sales BHBU - White Plains, NY Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - New York Location (City) Field Based Amgen Job Description Territory # 51401, White Plains, NY; covering White Plains-Paramus, NJ; Spring Valley, NY; Bronx N, NY; Wayne, NJ; Bronx S, NY; Hackensack, NJ; Yonkers, NY; Bridgeport, CT; Stamford, CT This position will require strong ability to collaborate cross-functionally with other Amgen business units including District Sales Mangers, Regional Sales Directors and Corporate Account Managers. Candidates will need to fully understand the Primary Care/OBGYN/endocrinology and osteoporosis marketplace, develop business plans for their geography and implement national sales strategies and programs. Additional Responsibilities and Duties Include: - Track the progress of marketing messages and programs - Provide feedback to district teams on the marketing, allocating, monitoring, and leveraging of internal and external resources (e.g., discretionary spend) - Manage district teams to maximize their performance and help achieve/exceed sales and budget targets - Screen, interview, and hire candidates - Ensure compliance with training - Demonstrate the appropriate coaching and counseling to prepare individuals for future development - Conduct annual and on-going performance reviews and competency assessments - Communicate and coordinate with both district and cross-functional teams (e.g., Marketing, Finance, other Business Units) - Share best practices with direct reports and peers - Coordinate and/or participate in cluster teams - Conduct district sales meetings to guide districts - Develop local Opinion Leader relationships to achieve aligned objectives Basic Qualifications - BS / BS degree is required - 8+ years pharmaceutical or biotech sales experience - 2+ years sales management experience (or management development program) Preferred Qualifications - 3+ years of specialty sales experience (Primary Care/OBGYN/endocrinology and osteoporosis marketplace) - Experience in biologics - Buy and bill model experience Additional Competencies: Ability to consistently and objectively recognize and promote success behaviors, as well as diagnose and change unsatisfactory behaviors through effective coaching; ability to leverage market & customer knowledge to strategically target messages, resources, and activities within the territory; demonstrates knowledge of local payor coverage; ability to understand and articulate clinical concepts, data, and conclusions; demonstrated ability to utilize clinical information to effectively address customer questions and objections; ability to recruit candidates that meet the minimum job criteria; interviews and hires sales representatives that are capable and committed to fulfilling the job requirements; strong sense of responsibility and demonstrated self-discipline; setting appropriate short term and long term objectives; demonstrated success in communicating & collaborating with sales staff, peers, business unit counterparts in an effective and timely manner.2012-04-30 18:49:33United StatesAmgenNew York15527BRNYField Based, NY28273677http://www.amgen.jobs/xml/28273677/jobUSAThousand OaksAuto req 15448BR Job Posting Title Sr Project Mgr - Product Strategy Team Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Job Summary The Sr. Project Manager provides project management support & leadership to PST sub-teams, sub-team projects and subprojects and is accountable to the Global Project Manager, Product Strategy Team & / or Research team leaders, and his/her functional line Supervisor. The Sr. Project Manager must apply project management best practices in the development, initiation, planning, execution, control & closing of projects. Key Responsibilities Team Leadership - Provide operational leadership in team and/or sub-team meetings and identify cross-functional implications, risks and issues. Elevate sub-team issues and work to overcome implementation obstacles at the functional level. Ensure strategic alignment between sub-teams and PST / Research project teams. Drive effective sub-team operations, including goal setting, sub-team charters, functional mgmt reviews, etc. and ensure that all goals and objectives are well understood by the various functional areas. Cross Functional Communication - Provide timely, accurate communication between teams / sub-teams and functional departments. Communicate appropriate information on functional team status & issues to stakeholders. Strategic Thinking - Actively participate in all PST sub-team discussions and ensure all views are heard and aligned. Assist teams and sub-team leaders in the development of plans, appropriate updates to plans, and management of the process to ensure Governance Board review and approval of changes to plan. Coordinate with the teams and the sub-teams to ensure sub-team plan alignment with the Project strategic plans. Risk Management - Conduct functional team-level risk assessment and scenario planning to support sub-team issues. Proactively drive development of contingency and/or risk-mitigation plans at the sub-team level. Resource Planning - Provide information to assist with resource planning at the sub-team level and elevate resource issues as needed. Identify and reconcile resource issues across sites or functions that may impact global coordination. Project Management Process - Manage all aspects of projects/processes: planning, estimating, sequencing and scheduling, monitoring and controlling, risk management, execution, and closing. Maintain a master project plan and schedule for assigned projects. Translate sub-team plans into actionable and measurable tasks. Follow up on action items from sub-team meetings. Establish and achieve project standards for work quality and quantity. Product Team Deliverables - Ensure adherence to Commercialization and governance processes at the sub-team level. Assist in the development/update of key Commercialization sub-team deliverables, e.g., sub-team plans, etc. Generate periodic updates and/or prepare formal presentations to line managers and/or others for all management reporting. Provide detailed data support for portfolio management/DA processes. Drive the development of functional plans, update plans appropriately, and manage the process to ensure Governance Board review and approval of changes to plan. Basic Qualifications Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications - Demonstrated experience in project management, business analysis, or managing and/or coordinating domestic and/or international product development - Project Management Professional (PMP) certification desired - MS, MBA or PhD - 7 or more years of experience in cross-functional pharmaceutical development project teams and/or experience with project management practice within the pharmaceutical industry - Experience working on late stage product development - Experience working on BLA/NDA regulatory filing activities - Experience in oncology drug development - Excellent verbal and written skills2012-04-29 19:44:08United StatesAmgenCalifornia15448BRCAThousand Oaks, CA28264320http://www.amgen.jobs/xml/28264320/jobUSAThousand OaksAuto req 15493BR Job Posting Title Specialist IS Business Systems Analyst - Field Sales support Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This Business Analyst within the North American Commercial Operations Information Systems (NACOIS) Field Sales Solutions will be responsible for partnering with the Sales Operations and Field Force to identify business needs and translate them into system requirements that can be successfully delivered by IS. This Business Analyst will manage clients’ demand, represent their interests, and will be accountable for coordinating efforts with vendors and IS partners (Global Commerial Operations IS Shared Services, Enterprise Business Intelligence (EBI)- Center of Excellence, and other Enterprise Systems groups) in the implementation and support of Business Intelligence solutions for Sales Operations and Field. Responsibilities include: • Plan and facilitate end-user sessions intended to surface requirements • Translate business needs into functional/non-functional system requirements • Presents designs, prototypes, and evolving solutions to assist with solution definition • Accountable for documenting detailed business requirements and business rules (use cases) • Accountable for documenting System Requirements Specifications • Analyzes and documents data requirements, flow and interdependencies • Participates in initial solution design • Ensures business requirements are met; participates in design reviews, develops traceability matrices to ensure requirements are developed, tested and delivered • Assesses impact that business requests, process and data changes may have on system(s) • Analyzes and recommend changes to improve business and IS processes • Ensures requests/projects are reviewed and approved through appropriate governance (Reporting Governance, GCOIS Portfolio Management, Global Commercial Operations Senior Leadership Team, ILM) • Acts as a project manager for incremental releases: o Develop project plan and schedule o Escalates and mitigates issues and risks o Consistently communicate the status of projects and requests o Ensures appropriate priorities are assigned to critical tasks o Develops test plan in partnership with IS peers (SIT) and Business (UAT) o Ensures test plan is successfully executed o Ensures clients expectations, project deliverables and milestones are met • Forecasts and proactively communicate resource demand to Enterprise Systems groups • Manages solution testing (IS and Business) and validation efforts • Develops strong subject matter expertise on business processes and related systems, and becomes a trusted partner and advisor to clients and IS partner teams. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Bachelor’s degree in Information Technology, Computer Science, Engineering, or Life Sciences • Master’s degree (Business, Information Systems, Project Management) • 3+ years IS experience working specifically on Business Intelligence (BI) solutions, preferably within bio/pharma industry • IS experience supporting field sales • Professional certifications, such as CBAP, PMP, ITIL, Six Sigma. • Proven analytical thinking and problem solving capability • Excellent oral and written communication and presentation skills with a business partner orientation • Excellent customer relationship and customer service skills • Proven skills in relationship building • Ability to understand clients needs and how technology contributes to the delivery of a product or services • Strong negotiation and influential skills • Ability to multi-task and meet deadlines in a fast-paced, changing environment. Self-starter with hands-on attitude. • Strong project management and organizational skills including effective delegation techniques, strong issues and risk management experience, and strong intra-team coordination skills • Ability to quickly understand new business processes and to recognize the relevant business questions associated with a business process • Ability to lead and influence various constituencies, including clients, other Business Analysts, and Technical Team members • Experience delivering solutions in a mixed-shore managed service delivery model • Experience in facilitating requirements gathering for complex solutions that involve multiple stakeholders and competing priorities • Experience with all technical components of BI solutions, including data modeling, ETL, Reporting and Analysis, Data Quality, etc. • Understanding of basic types of database structures including 3NF, dimensional, and multi-dimensional models • Ability to do detailed data and systems analysis • Ability to write SQL queries • Experience in testing and validating BI solutions • Experience with Informatica, Cognos, Veeva and/or DataFlux.2012-04-28 20:25:59United StatesAmgenCalifornia15493BRCAThousand Oaks, CA28261413http://www.amgen.jobs/xml/28261413/jobUSAThousand OaksAuto req 15509BR Job Posting Title Principal IS Architect (IS Infrastructure Service Manager for External Hosted Services) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The primary responsibility of this position is to provide infrastructure service management responsibilities for Amgen applications that are hosted externally (e.g. SharePoint, External Amgen websites.). This position is the focal point for all infrastructure operational activities related to these external hosted Enterprise applications. - Act as an Infrastructure lead for Amgen IS staff that are in the process of engaging an externally hosted environment. o Document and understand the cost associated in integrating with Amgen account provisioning process ( e.g. IDM, LDAP, Account Federation) o Identify the cost of additional network connections that are called out ( WAN) o Understand any inter-independency of the Application Hosting environments (server, database, middleware management) o Understand how changes are implemented (e.g. change control process) o Assure appropriate assessments are complete and adequate, including Architectural and Security assessments - Provide single point of contact and oversight to ensure the following infrastructure items are covered in the contractual agreement: - Redundant infrastructure - Platform operations management - Middleware/database operations management - Change & Release management - Incident & Problem management - Availability, performance and capacity management - Lay out infrastructure roadmap, strategy and guidelines for how Amgen would engage such external hosted environments (e.g. synergy possibilities of multiple services hosted with one vendor) - Standardize solution by developing a checklist or specification, such as providing a standard list of non functional (e.g. infrastructure) requirements. - Collaborate with Global Strategic Sourcing to ensure service contract covers appropriate service levels, metrics, requirements, and financial incentives/penalties for infrastructure related services - Assist with operational escalations as necessary - Work in/with cross functional teams and initiatives Responsibilities also include driving alignment and compliance with existing and new global processes, and ensuring that external hosting environment for infrastructure services are managed in a consistent and disciplined manner. The position will also require an in-depth understanding of the overall infrastructure requirements for external hosting environment, so he/she is effective in working with external vendors and Amgen Infrastructure organizations ( e.g. Data Center facilities personnel, network and storage teams, Identity Management team, and operating system and database teams). Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Master’s Degree in Computer Science, Information Systems, or Business Administration Extensive domain knowledge 6+ years experience in supporting and managing operations in a globally diverse corporate enterprise environment. Very strong fundamental knowledge of TCP/IP, DNS, and VPN technology Extensive understanding and knowledge working as a network engineer in a large enterprise environment Extensive knowledge in Identity Management support ( e.g. Site Minder, LDAP, AD, Kerberos, Single Sign On and Federation concepts) Good knowledge of server and database administration to support high availability architecture The following certifications are a plus: TCCNA, CCIE, MCSE An in-depth understanding of the overall infrastructure requirements for external hosting environment, so that candidate is effective in working with external vendors and Amgen Infrastructure organizations ( e.g. Data Center facilities personnel, network and storage teams, Identity Management team, and operating system and database teams). Knowledge of IS quality and compliance policies & SOPs Strong oral and written communication skills, excellent interpersonal skills, and the ability to interact well with multiple levels of management. Excellent data-driven problem solving and analytical skills Good organizational skills, and ability to concurrently manage multiple assignments. Experience leading large initiatives in multiple functional areas of a complex organization. Proven experience as part of a high performance team. Understanding of, and experience with, ITIL 3.0 best practices and enterprise change control procedures.2012-04-28 20:25:01United StatesAmgenCalifornia15509BRCAThousand Oaks, CA28261412http://www.amgen.jobs/xml/28261412/jobUSAThousand OaksAuto req 15526BR Job Posting Title Human Resources Senior Manager Career Category Human Resources Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The successful candidate will be a Sr Human Resources Business Partner (Sr HRBP) for one of Amgen’s functional area business units. The Sr HRBP will be a strategic partner for client group management teams to help their staff and organizations reach their full potential. This position provides the opportunity to develop solutions to a variety of complex HR problems in support of designated client groups in a fast-changing environment. This Sr HRBP will use consulting skills to help clients achieve business objectives and increase the effectiveness of their organizations. They also will coach clients on a variety of HR and business-related issues to effect change in the organization. Additional responsibilities include staff relations responsibilities, including leadership development, rewards and recognition, talent management, engagement and retention, conducting investigations and making disciplinary recommendations, and the roll out of corporate HR programs. This position will be located at Amgen’s corporate headquarters in Thousand Oaks, CA. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree or & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications MBA or other Masters degree with emphasis in such areas as organizational development, management, human resources development, physical sciences or equivalent highly desired. Industry knowledge also highly preferred. Minimum 8 years of progressively complex/strategic HR experience, including organization effectiveness, staff relations, compensation, staff development and recruitment. Demonstrated ability to understand the clients’ needs and develop both strategic and tactical solutions to tangible business challenges; sound knowledge of applicable employment laws, regulations, and business practices related to the field of Human Resources. Demonstrated ability to learn and understand multiple therapeutic areas, products, and selling models. Strong analytical, problem solving, consulting, and project management skills. Strong communication and interpersonal skills required. Ability to interact with and influence all levels of staff, management, and executives. Ability to partner with HR functions. Some travel is required.2012-04-28 20:22:41United StatesAmgenCalifornia15526BRCAThousand Oaks, CA28261403http://www.amgen.jobs/xml/28261403/jobUSAThousand OaksAuto req 15381BR Job Posting Title Specialist IS Bus Sys Analyst (Web and Collaboration - Sharepoint) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The successful candidate will establish and maintain a positive business relationship with managers, staff and external business partners that utilize the COE’s services. He or she will demonstrate a thorough ability to obtain understanding of the functional area business models, processes, and priorities, and leverage that knowledge in the delivery of production solutions to meet client automation needs. He or she will participate in and/or facilitate cross-functional team meetings to discuss and optimize business process automation and will present key findings to Information Systems and business management. He or she will coordinate the efforts of other Information Systems groups in the delivery of support for the assigned functional areas. He or she will: • Understand business requirements and current process and help find ways to improve using OOTB SharePoint functionality. Help business clients learn to construct complex solutions in SharePoint. Balance finding solutions with maintaining client’s ability to understand and support going forward. • May lead Internal SharePoint Technical Consulting team - Lead a team of SharePoint experts to provide internal "consulting" services to business functions across the enterprise • Lead projects involving custom development work for Enterprise Collaboration, Portal, and Extranet platforms • Participate in architecture, strategy and direction for Enterprise Collaboration, Portal, and Extranet platforms • Manage expert SharePoint contract resources hired by the business. Define a stable, realistic, repeatable model for these types of engagements Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelor's degree in Computer Science, or Master's degree in Computer Science Excellent documentation and writing skills are crucial. The ability to develop, document and communicate processes and follow accepted Amgen IS policies and standards is mandatory. The ability to identify business patterns used for collaboration and translate the patterns into standardized solutions using SharePoint technologies is a key skill set. Ability to use initiative for proactively engaging clients to help them scope their needs and develop solutions is crucial. Candidates must be able to work independently and provide recommendations on strategies for meeting client needs within the scope of the COE’s service offerings. He or she should have the ability to see the big picture and zoom-into specific areas to provide a creative approach to problem solving, innovation and issue resolution. The Candidate should have good interpersonal skills and the ability to communicate and collaborate proactively with others. Candidates should possess a strong ability to learn new technologies, and be able to work in a high pressure, fast paced environment. Experience with software development processes including source code control, functional and performance testing, and technical documentation, as well as, experience managing an enterprise-class system is highly desired. Preferred areas of knowledge: • SharePoint 2007 or SharePoint 2010 • Microsoft SharePoint development best practices (experience using ASP.NET or C#) • Microsoft Online Services (BPOS/Office365) • Building complex OOTB SharePoint solutions with no development • Web technologies (full stack understanding) • CS fundamentals • Project management; team leadership • Vendor Management • Formalized requirements gathering • Design Specifications • Software Development Methodologies • Unit and Integration Testing2012-04-27 20:21:50United StatesAmgenCalifornia15381BRCAThousand Oaks, CA28241202http://www.amgen.jobs/xml/28241202/jobDEUMunichAuto req 15521BR Job Posting Title Praktikant/in Marketing Hämatologie/Onkologie Career Category Marketing Employee Subgroup Co-Op FT Salaried Country (State/Region) Germany Location (City) Munich Amgen Job Description Ab sofort für suchen wir für einen Zeitraum von mindestens 6 Monaten einen engagierten und motivierten Studenten oder Absolventen der Pharmazie, Humanbiologie, Biologie, Biochemie, Medizin oder Betriebswirtschaft (bzw. mit ähnlichem Studiengang) als Praktikant (m/w) für den Bereich Marketing Hämatologie/Onkologie Sie lernen die vielfältigen Prozesse innerhalb des Bereiches Marketing kennen und unterstützen die Produktmanager sowie Marketing-Assistentinnen bei unterschiedlichsten Aufgaben, wie z. B. • Ausarbeitung von Informationsmaterialien • Unterstützung bei der Organisation von Weiterbildungen • Umsetzung der Außendienstkampagnen • Erstellung von Präsentationen/Übersetzungen • Allgemeinen administrativen Aufgaben • Übernahme von eigenständigen Projektaufgaben innerhalb der Marketing Abteilung Basic Qualifications • Studium der Pharmazie, Humanbiologie, Biologie, Biochemie, Medizin - alternativ Betriebswirtschaft (Vordiplom jeweils vorausgesetzt) • Medizinisches Verständnis erwünscht • Gute Kenntnisse im Umgang mit dem PC (MS Office) • Sehr gute Deutsch- und gute Englischkenntnisse - schriftlich wie mündlich • Gute Kommunikationsfähigkeiten • Pro-Aktivität, Kreativität, Teamorientierung und Flexibilität • Zeit für ein 6-monatiges, vergütetes Praktikum (gerne auch Pflichtpraktikum) Preferred Qualifications Sie erhalten hervorragende Einblicke bei dem weltweit größten Biotechnologie-Unternehmen und die Gelegenheit, Ihre fachlich-professionellen Fähigkeiten sowie auch Ihrer persönlichen und sozialen Kompetenzen weiter zu entwickeln. Unser Arbeitsumfeld ist von Offenheit und Erfolgsorientierung geprägt - der Teamgedanke wird groß geschrieben. Konnten wir Ihr Interesse wecken? Dann freuen wir uns auf die Übermittlung Ihrer aussagefähigen Bewerbungsunterlagen (Anschreiben, Lebenslauf, Zeugnisse) über unser online-Recruitingportal. Für weitere Informationen zu AMGEN laden wir Sie herzlich auf unsere Homepage unter www.amgen.de ein. Für Fragen vorab steht Ihnen Frau Martina Rech (Staffing Manager) unter der Telefonnummer (089) 14 90 96-11 12 gerne zur Verfügung.2012-04-27 20:21:34GermanyAmgenNone15521BRNoneMunich, DEU28241188http://www.amgen.jobs/xml/28241188/jobIRLDun LaoghaireAuto req 15363BR Job Posting Title Mgr Maintenance Career Category Maintenance Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Maintenance Manager – Level 5 Amgen Dun Laoghaire - Dublin This role leads a small group of engineers / technical professionals delivering a technical service requiring the job holder to apply knowledge and experience of engineering principles to a broad variety of assignments. Principally the jobholder will develop technical solutions to complex problems, while managing, coordinating and reviewing the work of others. •Carry out fault investigation and problem analysis for maintenance related issues, identify alternative solutions, prepare proposals for modifications or improvements and execute/trial as necessary •Provide input at various project stages to review maintainability – be involved in new equipment installation and accept handover from project teams to maintenance. Check technical content of handover documentation and ensure PM system is updated. •Administer control and develop PM System, provide technical input for developing PM’s and for other maintenance aspects of maintenance documentation; assisting with equipment/process fault identification and improvements. •Administer and control planned maintenance systems ensuring work orders are issued, completed and returned on time, running reports, analysing trends and issuing proactive worksheets. •Provide technical input into preparation and issue of SOP’s; corrective action tracking; operation and maintenance manuals. •Assist with preparation and co-ordination of shutdown activities, manage and review activity schedules and produce summary reports •Conduct area self assessment and implement corrective actions, evaluate new equipment/processes for safety issues related to maintenance functions. Conduct departmental risk assessment in conjunction with the EHS department. •Participation in ‘call-out system’ to cover Engineering response (out of normal hours, management of weekend maintenance activities Basic Qualifications •Bachelor's degree in Engineering, Science or related field. •Significant relevant work experience within operations/manufacturing environment •Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) •Established expertise in multiple areas of engineering technology. Preferred Qualifications •Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope. •Working knowledge of financial analysis tools' and appreciation for project cost development •Demonstrated Skills in the following areas: Negotiation, persuasion and facilitation. •Written communication including technical writing. •Team leadership skills: Management, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.2012-04-27 20:21:28IrelandAmgenNone15363BRNoneDun Laoghaire, IRL28241185http://www.amgen.jobs/xml/28241185/jobUSAField BasedAuto req 15438BR Job Posting Title Sr Biopharmaceutical Rep, Oncology - Dallas, TX Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Texas Location (City) Field Based Amgen Job Description Territory:(#17414) Dallas-North, TX - covering - Dallas, Irving, Las Colinas, Plano, Mesquite, McKinney, Richardson, Lewisville As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-04-27 20:20:57United StatesAmgenTexas15438BRTXField Based, TX28241167http://www.amgen.jobs/xml/28241167/jobFRANeuilly-sur-SeineAuto req 15485BR Job Posting Title Associate Contracts & Pricing Career Category Sales & Marketing Operations Employee Subgroup Salaried FT Country (State/Region) France Location (City) Neuilly-sur-Seine Amgen Job Description 40000320, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40000320, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40000320, To Be Added When Table Structure is Built, - Preferred Qualifications2012-04-27 20:20:46FranceAmgenNone15485BRNoneNeuilly-sur-Seine, FRA28241160http://www.amgen.jobs/xml/28241160/jobINDMumbaiAuto req 15167BR Job Posting Title Sr Mgr Regulatory Affairs (Supplier Process Owner) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) India Location (City) Mumbai Amgen Job Description Group Purpose – Supplier Management: _ Maximizing the value of suppliers - Implementation of supplier management strategies - On-site supplier site operations (technical) Job Summary: - On site supplier management of key GRAAS Suppliers - Site operations oversight - Subject matter expertise for regulatory and safety activities - Liaise between functions, SPOs and Quality and supplier - Day to day monitoring of on site productivity and quality Key Activities: Strategy Development - Provide input into strategic design and implementation for processes, systems and supplier organization design Supplier Start-up and Engagement - Provide technical expertise and guidance to suppliers, with minimal supervisions and oversight - Troubleshoot technical start up issues, and resolve with supplier management team while in alignment with stakeholder expectations - Support training of suppliers - Liaise between supplier and functional teams on technical issues Relationship Management - Lead / participate in resolution of technical / business / financial / productivity or site operations issues with suppliers Operations Management - Provide on-site day to day management of overall site operations (i.e. – scheduling, expenses, status reporting, issue/risk management etc) - Provide leadership and direction to supplier management team on a day-to-day basis - Provide on site subject matter expertise and guidance to suppliers - Provide on site monitoring of completion of work in accordance with service level agreements (SLAs) and contracts, and developing and implementing CAPAs - Provides on site knowledge of drug development and commercialization to supplier oversight - Provides on site working knowledge of regulatory guidelines, familiarity with US FDA, EMEA regulations, cGCP and other relevant regulatory frameworks to supplier performance - Develops supplier teams by leveraging good communication skills, quality principles and ability to mentor Quality Management Support - Review and maintain KCI, KPI, metrics, compliance related documentation, and conduct / complete RCA / CAPA activities - Lead / manage on site operational process improvement Basic Qualifications - Doctorate degree and 2 years of directly related experience OR - Master’s degree and 6 years of directly related experience OR - Bachelor’s degree and 8 years of directly related experience OR - Associate’s degree and 10 years of directly related experience OR - High school diploma / GED and 12 years of directly related experience Preferred Qualifications - MD, DO, PhD, PharmD - 9+ years work experience in life sciences or medically related field, including 6+ years of biopharmaceutical drug development experience (obtained working at a biotech, pharmaceutical or CRO company) - Direct experience with either Pharmacovigilance, Regulatory, or Records Management - Experience at, or oversight of, drug development suppliers (CROs, central labs, imaging suppliers, etc.) - Experience working in a global, matrix organization - Knowledge of Quality Management, Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines - Extensive project management/project planning experience - Proficiency in anticipating and resolving problems - Experience writing and presenting clearly on scientific and clinical issues - Experience leading teams in a matrix environment - Excellent interpersonal, organizational, supervisory skills - Professional collaboration and leadership skills2012-04-26 18:21:18IndiaAmgenNone15167BRNoneMumbai, IND28203658http://www.amgen.jobs/xml/28203658/jobUSAThousand OaksAuto req 15474BR Job Posting Title Dir Regulatory Affairs (Global, Biosimilars) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The purpose of this group is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans. Job Summary: - Provide global regulatory leadership and support to the Amgen Biosimilars Operating Unit - Facilitate product development and global registration of the Amgen biosimilar portfolio by developing and executing regulatory strategies - Ensure that regulatory approvals to support clinical trials are acquired and maintained - Achieve desired global labeling that are compliant with regulatory requirements - Manage effective interactions with regulatory authorities Key Activities: Regulatory Strategy & Filing - Provide expertise and leadership in the development, communication, and implementation of approved global regulatory strategies and plans in support of biosimilar goals and product portfolio execution - Lead and provide regulatory direction to cross-functional teams - Ensure regulatory documents are developed with high quality, delivered in a timely manner, consistent with biosimilars strategies, and compliant with current global regulatory authority requirements - Ensure all filings are maintained per regulatory requirements - Ensure development and execution of clinical/ non-clinical strategies, including regulatory review, input and advice for study concept documents, study protocols, informed consent forms, statistical analysis plans, clinical study reports, and related regulatory documents required to support product development and registration - Ensure development of product labels and core data sheets - Identify process needs to meet internal challenges Regulatory Interactions - Plan, execute and lead agency meetings per regulatory strategy - Lead the generation and submission of briefing books to support regulatory interactions - Facilitate ad hoc interactions, RTQ responses and meetings - Ensure coordinated planned and ad hoc contacts with regulatory authorities on the development and registration of biosimilar products Regulatory Intelligence - Monitor, assess and implement regional regulatory requirements - Review and assess impact of regulatory decisions for competitive products - Ensure that biosimilar regulatory intelligence gained by the Biosimilars Regulatory Function is communicated to the Biosimilars Operating Unit, other Amgen functions and partners as appropriate Biosimilars Policy - Provide subject matter expertise to GRAAS Biosimilars Policy function as required Collaboration - Ensure that regional regulatory activities are appropriately coordinated with Amgen affiliates - Support vendor oversight and management for regulatory and safety operations - Escalate regulatory issues, progress, and metrics to the GRAAS Biosimilars function - Represent Biosimilars Regulatory Affairs on committees, as necessary - Share insights on biosimilar regulatory requirements with colleagues Basic Qualifications - Doctorate degree and 4 years of directly related experience OR - Master's degree and 8 years of directly related experience OR - Bachelor's degree and 10 years of directly related experience AND 4 years of direct managerial and /or leadership experience Preferred Qualifications - Experience in the biosimilars/ biotechnology industry - Experience in interacting with regulatory agencies - Regulatory submissions experience - Experience interacting with senior regulatory agency representatives - RAC - Regulatory knowledge of global regulations - Familiarity in working with policies, procedures and SOPs - Understanding of drug development - Comprehensive understanding of Regulatory and Safety functional activities and how they affect projects and processes - Regulatory experience with product filings - Experience interacting and communicating with senior executives and teams regarding strategic issues to ensure expectations are understood - Experience communicating and clearly presenting strategic and business issues - Experience leading teams and projects in a global, complex, dynamic, regulated matrix environment - Deep knowledge of strategic management models and frameworks - Ability to understand and communicate scientific and clinical information - Ability to anticipate and prevent potential issues - Ability to manage and mentor others - Cultural awareness and sensitivity to achieve results across different regions2012-04-26 18:20:02United StatesAmgenCalifornia15474BRCAThousand Oaks, CA28203630http://www.amgen.jobs/xml/28203630/jobUSAThousand OaksAuto req 15401BR Job Posting Title Clinical Data Mgmt Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Clinical Data Management Manager will be accountable for CDM study activities and oversight of the CROs and the Functional Service Provider for multiple therapeutic areas including Early Development Oncology. This role is part of a Therapeutic study team located at Amgen's headquarters in Thousand Oaks, CA . The preference is for the person to be located in Thousand Oaks, CA. The Clinical Data Mgr’s responsibilities include: Co-ordination and mentoring of lead data managers within assigned projects Leading CDM activities for assigned study teams Ensuring clinical projects are executed according to set timelines with quality and consistency Ensuring that CDM procedures and processes are adhered to Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelors degree in life science, computer science, business administration or related discipline 6+ years work experience in clinical data management in the Pharmaceutical or Biotech arena 3+ years project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc.) Experience working in Medidata Rave 5.x Solid understanding of clinical data handling procedures related to clinical oncology in solid tumor indications2012-04-26 18:19:48United StatesAmgenCalifornia15401BRCAThousand Oaks, CA28203622http://www.amgen.jobs/xml/28203622/jobUSAThousand OaksAuto req 15503BR Job Posting Title Contracts & Pricing Director Career Category Sales & Marketing Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Position Responsibilities/Accountabilities • Facilitates the development of comprehensive, multi-year U.S. pricing strategies—including list price and contracting—for the relevant brands/business segments; recommends discrete price actions to adjudicate pricing issues as they arise. • Maintains excellent relationships with relevant Business Unit, Finance, Business Law, Global Government Affairs, and Global Payor Planning stakeholders to ensure pricing strategies are aligned with brand goals, consistent with global price guidelines, socially responsible, financially sound, and legally compliant. • Responsible for the implementation and rollout of specific pricing actions supporting the U.S. pricing strategy through superior leadership of the cross-functional Pricing and Contracting Segment Team”. • Accountable for the latest estimate discount rate (LEDR) forecasts for relevant brands, ensuring forecast accuracy and SOX compliance of the forecasting process. • Accountable for government price forecasts for Average Selling Price (ASP), Best Price (BP), and Average Manufacturer Price (AMP) for relevant Amgen and competitor products, ensuring forecast accuracy and reconciling forecasts to actual price submissions. • Leads a team of ~3-4 direct report pricing professionals, establishing standards and norms of conduct for professional behavior; creates a climate in which performance standards are continually raised and staff are developed through regular, specific and actionable coaching. • Closely collaborates with Amgen’s Business Units and Corporate Account Payer Reimbursement Organization to develop Commercial and Medicare Part D contracting strategies. Also leads internal approval process and subsequent roll-out to field management. Basic Qualifications • Doctorate Degree & 4 years of directly related experience OR • Masters Degree & 8 years of directly related experience OR • Bachelor’s Degree & 10 years of directly related experience AND Preferred Qualifications • 6 years of direct managerial and/or leadership experience • Excellent conceptual problem solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution • Strong oral/written communications skills and interpersonal skills with Senior Management presence”; able to communicate at all organizational levels • Proven ability to manage in a highly fluid, interactive, matrixed environment; demonstrated ability to successfully manage multiple simultaneous, complex projects to completion • Authoritative command of complexity and ambiguity; ability to see the big picture; ability to collect, digest and assemble information to enable relevant business analyses and influence decision-making • Excellent technical skills and fluency with spreadsheet model design and/or software development. • Deep understanding of the U.S. Government and Commercial reimbursement environment. • Previous Managed Markets Contracts and Pricing experience with a large Bio / Pharma company preferably in a leadership role2012-04-26 18:19:24United StatesAmgenCalifornia15503BRCAThousand Oaks, CA28203613http://www.amgen.jobs/xml/28203613/jobGBRCambridgeAuto req 14537BR Job Posting Title Regulatory Affairs Senior Mgr Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Uxbridge Amgen Job Description The purpose of this role is: •To ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products •To ensure regulatory compliance, with a focus on patient safety •As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade) This role is responsible for: •Advising the GRT on regional considerations in developing strategy •Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders • May manage one or more regional leads or support roles Key Activities: 1.Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements. 2.Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements. 3.Leads development of regional regulatory documents and meetings in accordance with GRT strategy 4.Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan) 5.Directs the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent. 6.Manages regional label negotiation activities 7.With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning 8.Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives 9.Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs) 10.Communicates regulatory strategies as appropriate such that expectations are understood. 11.Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management 12.Develop predictions for expectations and risks associated with outcomes by regulatory agencies 13.Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments) Knowledge & Skills: 1.Regulatory knowledge in national regulations 2.Working with policies, procedures and SOP’s 3.Experience with national legislation and regulations relating to medicinal products 4.Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals. 5.Understanding of drug development Basic Qualifications - Doctorate degree and 2 years of directly related experience OR - Master’s degree and 6 years of directly related experience OR - Bachelor’s degree and 8 years of directly related experience OR - Associate’s degree and 10 years of directly related experience OR - High school diploma / GED and 12 years of directly related experience Preferred Qualifications • Experience gained within a biologics organisation • Second degree or further education/qualifications • Project management Expertise2012-04-26 18:18:54United KingdomAmgenNone14537BRNoneCambridge, GBR28203603http://www.amgen.jobs/xml/28203603/jobUSAThousand OaksAuto req 15397BR Job Posting Title Exec Dir Compliance Career Category Compliance Employee Subgroup Executive FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Executive Director Compliance role is responsible for planning, organizing, and directing all activities related to ensuring the R&D organization’s compliance with regulations and requirements specifically managing the R&D audit functions and compliance advice activities. Key responsibilities for this position include: • Conceives and directs audit and compliance strategies designed to ensure acceptability of regulatory applications and compliance of post marketing activities (pharmacovigilance and labeling) • Provides comprehensive assurance that activities regulated by good pharmacovigilance practices (GPvP), good clinical practices (GCP) , and Good Laboratory practices (GLP) are compliant with external regulatory guidelines and internal company policies and procedures. • Ensure Senior Management is informed of all critical compliance issues in a timely manner; aggregate issues on an ongoing, periodic basis • Lead, manage and motivate a team of approximately fifty staff. • Collaborate with the R&D organization to develop best practices and provide guidance as necessary to ensure compliance across teams • Evaluate the need for, and oversight of audits of external investigator sites, vendors, and internal processes including documentation systems and compliance with appropriate regulations • Develops and implements risk management processes used to establish the need for compliance, assign appropriate priority to efforts, and allocate appropriate resources needed to ensure full compliance. • Monitor, evaluate, and manage the resource implications resulting from regulatory inspections and the rapid growth of regulated systems. • Assure effective management of all R&D regulatory authority inspections and advise development teams regarding effective management of clinical site and/or vendor inspections • Identify and follow up on corrective action plans arising from audits involving training as necessary • Engage with leaders in other compliance organizations within Amgen • Contributes to the overall strategy of the Commercialization and R&D Compliance organization. Basic Qualifications • 6 years of direct managerial and/or leadership experience, AND • Doctorate degree & 6 years of directly related experience, OR • Master’s degree & 10 years of directly related experience, OR • Bachelor’s degree & 12 years of directly related experience Preferred Qualifications • JD or MBA • 10 years experience managing compliance and/or regulatory affairs or legal teams in a major pharmaceutical or biotech company, including GCP and GLP • Excellent working knowledge of US and Global regulations pertaining to GCP, GLP, CFR, ICH, MHRA Pharmacovigilance inspection program. • Knowledge in GMP, pharmacovigilance, healthcare compliance and research compliance desirable • Experience in other related areas of compliance including OIG, GMP • Proven communication skills; teamwork and negotiation skills; ability to work through conflicting situations • Excellent technical writing skills Competencies To perform the job successfully, an individual should demonstrate the following competencies: • High level of organizational skills and flexibility with the ability to prioritize • Ability to integrate company goals and strategies with compliance requirements • Strong knowledge in the areas of medical and regulatory affairs and the drug development process • Strong ability to champion” internal policies for audit internal procedures. • Ability to communicate effectively orally and in writing. • Ability to gather information from multiple sources to understand problems; strong problem solving abilities. • Demonstrated leadership ability. • Ability to maintain confidentiality at all times is required.2012-04-25 21:11:44United StatesAmgenCalifornia15397BRCAThousand Oaks, CA28183917http://www.amgen.jobs/xml/28183917/jobUSACambridgeAuto req 15355BR Job Posting Title Scientist Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - Massachusetts Location (City) Cambridge Amgen Job Description Amgen is seeking a creative and highly-motivated Scientist to be part of a newly formed Therapeutic Innovation Unit at the Amgen Cambridge Research Center in Cambridge, MA. The Innovation Unit's mission is to carry out broad impact research projects that have the potential to significantly impact human disease outcomes. In this role you will use a strong background in molecular and cellular biology and have a working knowledge of genomic and bioinformatics tools. Additionally, you will use proven analytical and problem solving skills combined with the drive and scientific curiosity to successfully utilize the latest findings and technologies in our research programs. In this role you will work in a collaborative environment and on interdisciplinary teams. Basic Qualifications • Doctorate degree OR • Master’s degree & 6 years of scientific experience OR • Bachelor’s degree & 8 years of scientific experience Preferred Qualifications • A Ph.D. degree in the life sciences with 3-5 years of postgraduate research experience • A well-documented background of scientific expertise in molecular and cell biology. Experience in cell signaling and/or immunology is preferred • Experience with shRNA screening and Lentivirus experience is a plus • Ability to propose and implement scientific ideas consistent with the strategic needs of the Therapeutic Innovation Group • Excellent communication and interpersonal skills as well as the ability to function successfully in a matrixed team environment2012-04-25 21:10:36United StatesAmgenMassachusetts15355BRMACambridge, MA28183870http://www.amgen.jobs/xml/28183870/jobUSABoulderAuto req 15452BR Job Posting Title Senior SAP BASIS Systems Administrator (Java; Portal XI/PI) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California United States - Colorado Location (City) Boulder Thousand Oaks Amgen Job Description The Senior SAP BASIS Systems Administrator (Java; Portal XI/PI) (formal Amgen title is Specialist IS Programmer Analyst) can be located at either Amgen's site in Boulder, Colorado, or Amgen's headquarters in Thousand Oaks, CA. As part of the Amgen IS Shared Services organization, the Specialist IS Programmer Analyst will: lead the design and oversee development of cross-functional, multi-platform application systems; provide technical and process leadership while partnering with client-facing IS team to drive the tactical delivery of application solutions; integrate systems across Amgen infrastructure and services; set guidelines based on existing SOPs and standards as to the proper use of application development and integration patterns; partner with architects, business analysts, system administrators, information security, project managers and other parts of internal solutions delivery and support teams as well as business partners to implement complex solutions; provide focused consulting services on projects and govern compliance of those projects with architecture standards and roadmaps while ensuring that the design and development teams remain compliant with evolving enterprise standards. Additionally, responsibilities include the following: • Identify risks and mitigations with project manager and technical team • Understand scope and high level requirements and lead the solution elaboration and implementation • Guide project team on elaborating significant architecture risks • Participate in requirements solicitation to better understand system requirements • Own System Design Specification (SDS)/System Detailed Design Specification (SDDS), with input and support from an architect and technical team, coordinating SDS/SDDS review and approval • Coordinate implementation activities and issue resolution for system deployment • Own Installation Qualification (IQ) process and documentation, with input and support from technical team, coordinating IQ review, approval and execution • Coordinate technical knowledge transfer with application support for post-go-live support • Occasionally involve in custom/interface development work on projects that require deep technical knowledge and skills (e.g. performance monitoring, early stage prototyping) • Experience in installation, configuration, and maintenance of various SAP systems (ECC/GTS/SRM/BW/SCM/PI/EP/SolMan) in WINDOWS / SQL Server environment • Manage and support multiple SAP landscapes • Assist in the planning, designing and architecture of SAP systems • Maintenance of multi-landscape environments through client copies, system refreshes, and transport management • SAP profile parameter changes, workload analysis, system error analysis and establishment of standard BASIS background jobs, system health checks, and monitoring • Impact analysis of new SAP releases to current system landscape environments • Analysis of system performance, database performance, system health checks and implementation of tuning improvements • Evaluate and apply SAP kernel patches and support packs • Perform system upgrades • Perform client and system copies; • Develop client and landscape strategies and batch scheduling • Troubleshooting of ABAP and Java stacks; Work with SAP in resolving the issues • Java Export and imports Basic Qualifications •Doctorate degree OR •Master’s degree & 3 years of directly related experience OR •Bachelor’s degree & 5 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Eight or more years of hands-on SAP Basis Administration, with emphasis in configuration, analysis, and troubleshooting in Netweaver 2004 and Netweaver 2004S systems. • Desire to continuously learn and take on new challenges with little oversight • Experience Installing, Configuring, Performance Tuning, Patching and Upgrading SAP NetWeaver (6.40, 7.x) • Ability to troubleshoot complex systems as well as provide root cause analysis • Extensive experience with Windows 2003 and 2008 Server as well as Microsoft SQL Server • Prior ownership of different SAP Usage Types (e.g., ECC, BW, XP/PI, Enterprise Portal, Solution Manager, APO) • Experience performing SAP System Refreshes and System Copies • Knowledge of web technologies, including web and application servers as well as some development experience (e.g., IIS, Apache, Weblogic, HTML, JSP) • Knowledge of SAP Java Transports using CMS, CTS or CTS+ • Experience configuring and supporting System Landscape Directory, configuring Data Providers and creating Business Systems and • Familiarity with highly available systems and services (e.g., Load Balancing, Disaster Recovery, Fault Tolerance) • Experience implementing Single Sign-On using Kerberos, SiteMinder or HTTP Headers • Working knowledge of public key encryption using PGP • Prior experience supporting EDI systems (e.g., Gentran Integration Suite, Sterling Integrator, Seeburger) • Excellent written and verbal communication skills; ability to clearly document operating procedures • Prior experience in a rigid change management environment • Familiarity with GxP, Sarbanes Oxley and Validated Computer Systems2012-04-24 20:54:07United StatesAmgenCalifornia15452BRCABoulder, CA28152864http://www.amgen.jobs/xml/28152864/jobUSAThousand OaksAuto req 15391BR Job Posting Title Sr Project Mgr - Drug Delivery Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Drug Delivery PMO is a function within Operations’ Drug Delivery organization that provides portfolio and project management leadership to advance device business process programs at Amgen and ensures the device development business and governance processes are followed. As part of the Drug Delivery PMO team, the successful candidate will support the Drug Delivery organization to: • Lead complex, cross functional business process projects for maturing the device business across Amgen and ensuring that it meets regulatory requirements. These projects will involve aligning disciplines such as Quality systems, commercialization, clinical trials, regulatory filings and design transfer. Current areas of focus will include integration of the device business process in Amgen’s Quality systems; ensuring that clinical trials management can effectively handle devices and ensuring that Device Design Control regulatory requirements are met through the device business process and Amgen’s systems. • Utilizing Operational Excellence discipline, drive sustainment and continuous improvements in the overall device business to drive efficiency and effectiveness. • Manage the development of best practices for tools and templates required for a device development projects Responsibilities Key responsibilities include, but are not limited to, the following: • Lead multi-disciplinary device business process projects with a clearly articulated scope using standard project management methodology. • Develop statements of work and manage outside consultants to provide subject matter expertise on projects • Lead functional stakeholders in defining scope, risks and schedule to integrate device requirements into current business process and quality systems. • Support the creation and management of a master device business process maturity strategy • Accountable for defining, leading, and delivering results for projects supporting device network goals • Own deliverables throughout project lifecycle, aligning work from a broad set of project stakeholders • Integrate all key activities and project milestones into the master device business process maturity plan • Represent program in routine leadership briefings and stakeholder communications for aspects of assigned initiatives Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelor’sDegree in engineering, life-science or business and 8 years of directly related experience Experience working on medical devices Knowledge of Amgen’s current commercialization process 7 or more years in Continuous Improvement, Industrial Engineering, Lean Manufacturing, Six Sigma or related functional experience within Quality, Manufacturing, Development, Research or Process Development Certified or experience in process improvement methodologies such as Six Sigma/DMAIC/DFSS or PDCA Demonstrated ability to forge and maintain strong relationships with multiple functional areas Strong leadership skills Ability to tactfully and effectively negotiate and influence Ability to communicate and present ideas to all levels of staff and management Be a team player and self-starter who is capable of growth and increased responsibility Proficient in basic project management methodology and tools Good analytical problem solving skills Proficiency in MS office suite including Excel, Power Point, and Project2012-04-24 20:53:48United StatesAmgenCalifornia15391BRCAThousand Oaks, CA28152837http://www.amgen.jobs/xml/28152837/jobUSAThousand OaksAuto req 15356BR Job Posting Title Sr Engineer - Drug Process Development Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Provide process development technical support to protein drug product manufacturing at Amgen contracted manufacturing sites including process performance; implementation of process improvement strategies; development of process models. • Act as a drug product contract manufacturing technical expert and team leader to provide leadership and solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation, for protein parenteral products. • Provide process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA, scale up, validation, and technology transfer. • Troubleshoot issues with drug product processing technologies and equipment. • Develop and characterize drug product processes and transfer technology to commercial drug product sites. • Conduct risk assessment for drug product operations and propose / implement appropriate CAPA. • Identify and implement operational opportunities for current and new sterile operations. • Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. • Travel to domestic and international contract manufacturing sites required Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • M.S. in Science or Chemical Engineering and 6 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation. • Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry with regard to chemical and physical stability is strongly desired. Excellent written and verbal communication skills. • Project management skills including the ability to manage multiple projects and evaluate project resource requirements. • Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. • Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.2012-04-24 20:51:14United StatesAmgenCalifornia15356BRCAThousand Oaks, CA28152785http://www.amgen.jobs/xml/28152785/jobUSABoulderAuto req 15454BR Job Posting Title Senior SAP BASIS Systems Administrator (Java; Portal XI/PI) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - Colorado Location (City) Boulder Amgen Job Description The Senior SAP BASIS Systems Administrator (Java; Portal XI/PI) (formal Amgen title is Specialist IS Programmer Analyst) will be located at Amgen's site in Boulder, Colorado. As part of the Amgen IS Shared Services organization, the Specialist IS Programmer Analyst will: lead the design and oversee development of cross-functional, multi-platform application systems; provide technical and process leadership while partnering with client-facing IS team to drive the tactical delivery of application solutions; integrate systems across Amgen infrastructure and services; set guidelines based on existing SOPs and standards as to the proper use of application development and integration patterns; partner with architects, business analysts, system administrators, information security, project managers and other parts of internal solutions delivery and support teams as well as business partners to implement complex solutions; provide focused consulting services on projects and govern compliance of those projects with architecture standards and roadmaps while ensuring that the design and development teams remain compliant with evolving enterprise standards. Additionally, responsibilities include the following: • Identify risks and mitigations with project manager and technical team • Understand scope and high level requirements and lead the solution elaboration and implementation • Guide project team on elaborating significant architecture risks • Participate in requirements solicitation to better understand system requirements • Own System Design Specification (SDS)/System Detailed Design Specification (SDDS), with input and support from an architect and technical team, coordinating SDS/SDDS review and approval • Coordinate implementation activities and issue resolution for system deployment • Own Installation Qualification (IQ) process and documentation, with input and support from technical team, coordinating IQ review, approval and execution • Coordinate technical knowledge transfer with application support for post-go-live support • Occasionally involve in custom/interface development work on projects that require deep technical knowledge and skills (e.g. performance monitoring, early stage prototyping) • Experience in installation, configuration, and maintenance of various SAP systems (ECC/GTS/SRM/BW/SCM/PI/EP/SolMan) in WINDOWS / SQL Server environment • Manage and support multiple SAP landscapes • Assist in the planning, designing and architecture of SAP systems • Maintenance of multi-landscape environments through client copies, system refreshes, and transport management • SAP profile parameter changes, workload analysis, system error analysis and establishment of standard BASIS background jobs, system health checks, and monitoring • Impact analysis of new SAP releases to current system landscape environments • Analysis of system performance, database performance, system health checks and implementation of tuning improvements • Evaluate and apply SAP kernel patches and support packs • Perform system upgrades • Perform client and system copies; • Develop client and landscape strategies and batch scheduling • Troubleshooting of ABAP and Java stacks; Work with SAP in resolving the issues • Java Export and imports Basic Qualifications •Doctorate degree OR •Master’s degree & 3 years of directly related experience OR •Bachelor’s degree & 5 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Eight or more years of hands-on SAP Basis Administration, with emphasis in configuration, analysis, and troubleshooting in Netweaver 2004 and Netweaver 2004S systems. • Desire to continuously learn and take on new challenges with little oversight • Experience Installing, Configuring, Performance Tuning, Patching and Upgrading SAP NetWeaver (6.40, 7.x) • Ability to troubleshoot complex systems as well as provide root cause analysis • Extensive experience with Windows 2003 and 2008 Server as well as Microsoft SQL Server • Prior ownership of different SAP Usage Types (e.g., ECC, BW, XP/PI, Enterprise Portal, Solution Manager, APO) • Experience performing SAP System Refreshes and System Copies • Knowledge of web technologies, including web and application servers as well as some development experience (e.g., IIS, Apache, Weblogic, HTML, JSP) • Knowledge of SAP Java Transports using CMS, CTS or CTS+ • Experience configuring and supporting System Landscape Directory, configuring Data Providers and creating Business Systems and • Familiarity with highly available systems and services (e.g., Load Balancing, Disaster Recovery, Fault Tolerance) • Experience implementing Single Sign-On using Kerberos, SiteMinder or HTTP Headers • Working knowledge of public key encryption using PGP • Prior experience supporting EDI systems (e.g., Gentran Integration Suite, Sterling Integrator, Seeburger) • Excellent written and verbal communication skills; ability to clearly document operating procedures • Prior experience in a rigid change management environment • Familiarity with GxP, Sarbanes Oxley and Validated Computer Systems2012-04-24 20:49:46United StatesAmgenColorado15454BRCOBoulder, CO28152730http://www.amgen.jobs/xml/28152730/jobGBRUxbridgeAuto req 15165BR Job Posting Title International Dev Medical Dir Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Uxbridge Amgen Job Description Overview: This is a newly formed role in the International Bone, Neuroscience & Inflammation TA. AMG 785 is a key program for Amgen and reached EoP2 in summer 2011 for the PMO program and is advancing into phase 3 with two phase 3 PMO protocols, currently planned to start enrollment in 2012. Ongoing phase 2 activities for this molecule includes fracture healing programs in hip and tibia fracture. Proof of concept does not yet exist in these indications. It is expected that the IML for AMG 785 partners with the Prolia IML as appropriate, since strategic alignment is required between these two molecules (partnered with UCB and GSK respectively). Key responsibilities: • Implementation and completion of AST’s (Amgen sponsored studies) • Leads development of study protocols for International AST’s; supports and executes international study protocol preparation, filing, review and approval in line with Amgen processes and policies • Ensures that International input is included as appropriate in GSP/GDP and global study protocols and SCD’s • Supports Affiliates in protocol development of Local AST’s and approves Local AST’s prior to IPRC submission (in conjunction with GDO) • Identify/resolve issues related to study design that arise during study execution • Provides interpretation of clinical study data and preparation/authoring of technical sections of clinical study reports, ensure consistency of CSRs for a clinical program • Participates in the development of Global strategies and tactics in close collaboration with the GDL and the International TA Head • Visits selected KOLs and study groups for strategic discussions and protocol development • Reviews International and Local ISS proposals • Partners with the International Brand Directors in the development and execution of the International product(s) lifecycle management plan • Oversees in-sourced/outsourced International medical programs and logistics • Supports regulatory and ethics approvals for Global development studies • Organizes and/or conducts International Advisory Board Meetings/Expert Panels and participates in Investigator Meetings, as appropriate • Member of respective IBT • Provides medical expertise for pipeline products • Provides medical expertise for Health Economy and reimbursement requests • Chairs the International Medical Team (IMT) Basic Qualifications • Medical degree with deep scientific expertise in Preferred Qualifications • Substantial clinical development experience, preferably from a pharmaceutical or possibly well established biotechnology company • Experience with clinical study management and conduct • Broad and formal leadership experience • Commercial acumen, ideally launch experience • Knowledge of pharmaceutical product development, product lifecycle and commercialisation process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs • Therapeutic area knowledge • Network of customer contacts in therapeutic area • Finance and budgeting experience2012-04-24 20:49:23United KingdomAmgenNone15165BRNoneUxbridge, GBR28152716http://www.amgen.jobs/xml/28152716/jobDEUField BasedAuto req 15382BR Job Posting Title Mitarbeiter/in wiss. Außendienst Häm/Onk-Gebiet: Hannover, Celle, Lüneburg.. Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) Germany Location (City) Field Based Amgen Job Description Mitarbeiter/in für den wissenschaftlichen Außendienst Hämatologie/Onkologie (XGEVA) Gebiet: Hannover, Celle, Lüneburg, Buxtehude, Stade, Verde, Nienburg Die Stelle ist zunächst befristet für 2 Jahre zu besetzen (Option auf Übernahme) AUFGABEN: • Sachkundige und umsichtige Beratung und Betreuung von Meinungsbildnern in Kliniken und Praxen miz dem Ziel, die vereinbarten Umsatzziele im Gebiet zu erreichen • Darstellung des Nutzens unserer Produkte für Patienten und Mediziner auf der Basis wissenschaftlich belegter Daten/Studien • Umsetzung wissenschaftlicher Erkenntnisse in verkäuferische Resultate • Enge Zusammenarbeit mit den Teamkollegen und den Spezialisten aus Key Account- und Produktmanagement Der Mitarbeiter berichtet an den regionalen Außendienstleiter Hem/Onc Team Nord. Basic Qualifications Fachlich: • naturwissenschaftliches Studium wünschenswert, evtl. adäquate Ausbildung • 3 bis 4 Jahre Berufserfahrung als Pharmareferent/Pharmaberater im Spezialaußendienst • vertriebsorientierte Ausbildung mit Berufserfahrung in kompetitiven Märkten und Erfahrung im wissenschaftlichen Außendienst • Kenntnisse und Berufserfahrung im Bereich Knochenstoffwechsel sowie Hämatologie/Onkologie/Urologie • gute Englischkenntnisse Persönlich: • Marketing- und vertriebsorientierte Denk- und Arbeitsweise • sicheres und gewandtes Auftreten, Überzeugungsfähigkeit, Akzeptanz bei anspruchsvollen Gesprächspartnern • ausgeprägte Kommunikations- und Teamfähigkeit • Reisebereitschaft und Pioniergeist Preferred Qualifications Wir freuen uns auf Ihre Online-Bewerbung. Bei Rückfragen kontaktieren Sie gerne Martina Rech (Staffing Manager) unter Tel. (089) 14 90 96-1112.2012-04-24 20:49:11GermanyAmgenNone15382BRNoneField Based, DEU28152707http://www.amgen.jobs/xml/28152707/jobUSAThousand OaksAuto req 15445BR Job Posting Title Sr Counsel - Healthcare Regulatory Career Category Law/Legal Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This experienced and knowledgeable attorney will provide strategic and practical advice to internal clients. This attorney will primarily provide legal support for Global Development, including Scientific Affairs and Global Health Economics, Global Regulatory Affairs and Safety, and Worldwide Compliance and Business Ethics. This individual will work directly with clients, providing counsel on a wide variety of drug development legal and regulatory issues. Experience dealing with healthcare/fraud and abuse issues and FDA regulatory issues is especially pertinent and experience with Privacy laws, clinical and consultant contracts, and/or products liability is also very relevant. This individual will work independently and in teams to identify and advise on business and regulatory issues with important legal implications. They will interact with clients and Law Department colleagues in different countries and across departments. Basic Qualifications JD degree from an accredited law school and admission to practice law required 4 or more years of experience practicing law Preferred Qualifications 6 or more years of practice at a national law firm, corporate law department, or a combination of both Experience working with the FDA and the laws and regulations relating to the discovery, development, approval, sales & marketing (including the federal and state anti-kickback laws) of biotechnology/pharmaceutical products Experience in a large law firm, biopharmaceutical company or major government agency Excellent interpersonal skills Ability to handle, prioritize and follow through on diverse issues on a timely basis Self-starter Resourceful and able to participate in highly collaborative, cross-functional team-oriented environment Ability to meet demanding deadlines Strong research and writing skills Manage multi-dimensional projects in fast paced environment Computer adept2012-04-21 18:47:48United StatesAmgenCalifornia15445BRCAThousand Oaks, CA28060958http://www.amgen.jobs/xml/28060958/jobUSAThousand OaksAuto req 15419BR Job Posting Title Business Performance Sr Mgr (R & D) Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role will be Research and Development focused but will also support other functional areas as well. The Sr. Manager of Business Performance will respond to project requests from executives and supervise / execute work with high quality results. In doing so s/he will structure the issues and analyses, manage the work, and prepare and present findings. This role will also support business functions by identifying opportunities and risks and developing the strategies to address them. The Manager of Business Performance will be responsible for developing approaches to improve productivity and implement comprehensive change strategies to transform an organization and enable it to adapt to business challenges. This role will interact with a wide range of leadership and staff inside and outside of Amgen (consultants). Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Doctorate or Masters in business, science, finance and/or technology • 5+ years experience in biotechnology /pharmaceutical • Experience at a top tier Management Consulting Firm • Strong presence with Senior Executives including ability to communicate effectively on a prepared and ad-hoc basis • Strong quantitative and qualitative analytic skills, specifically financial analysis with an emphasis on valuation • Certification in lean and / or Six Sigma • Excellent conceptual problem solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution • Strong leadership skills with a demonstrated ability to influence different styles • Proven experience as a member of a high performing team2012-04-20 18:41:04United StatesAmgenCalifornia15419BRCAThousand Oaks, CA28035846http://www.amgen.jobs/xml/28035846/jobMEXField BasedAuto req 15415BR Job Posting Title Regional Medical Liaison Employee Subgroup Salaried FT Country (State/Region) Mexico Location (City) Field Based Mexico City Amgen Job Description 40001026, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40001026, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40001026, To Be Added When Table Structure is Built, - Preferred Qualifications2012-04-20 18:40:25MexicoAmgenNone15415BRNoneField Based, MEX28035828http://www.amgen.jobs/xml/28035828/jobRUSField BasedAuto req 15414BR Job Posting Title ??????????????????? ????????????? (??????) Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) Russia Location (City) Field Based Amgen Job Description ??????????? ???????????: • ??? ???????????? ???????????? ?????? ??????? ???: ??????????? ? ????????? ?????????? ???????? ? ???????????? ? ?????????????? ???????????, ???????????????? ??????????? ?? ?????????. • ???????????? ? ???????????????? ?????????????? ?????????? ???????? ? ???????????? ? ?????????????? ??????????? ????????. • ?????????? ???????-???????????????? ??????????? ? ???????????? ????????????? ?????????? ????????. ??????? ?????????? ????? ??????????? ?? ???????????? ?????. • ??????????? ? ???????? ????????? ? ????????????? ????????????? ??????? ? ????????????? ?????????????. ????? ? ???????????? ????????? ? ?????????????? ????????????? ??????? ? ????????????? ?????????????. ???????????? ???? ??????? ? ???????? – ?? ????? 30 ? ??????. ?????????? ???? ?? ??? ?? ?????????? ??????? ??????????????? ????????????? ???????????????? ????????????? ? ?????? ???????? ? ???????? ???? ? ?????????? ? ??????????? ? ????????????? ??????. • ?????????? ??????????? ??????????? ??????????????? ? ???????? ?? ???????????????? ????? ? ??????????????? ???????, ????????? ????? ? ????????????? ?????????? ?? ????????? ? ?? ???? ?????? ????????, ?????????? ?????????? ??????????? ?????. • ??????????? ?????????? ? ??????????? ???????-???????????????? ?????????? ? ????????????? ?????????? ????????, ???? ?????????? ? ?????? ??????????? ? ??????????????. • ??????? ? ????????????? ???????????? ????????? ? ????????? ?????? ???????. • ??????????? ? ?????????? ???????? ??????????? (??????, ???????????, ????????, ???????????, ???????? ? ?. ?.) ? ????????, ??????? ? ???????? ??????????? ???????? ??????? ????????????? ?????. • ?????? ? ???????? ???????? ?????? ? ?????????: ?????????????? ?????? ??????, ??????????? ? ?? ????????, ???????? ???????? ?????????? ???????????. ??????? ?????????? ?? ???????????? ?????. • ??????? ? ?????????? ????????? ? ????????????? ??????????? (???????????). ??????????? ?????????? ???? ???????????. • ?????????? ????????? ????????????????? ??????. ??????? ? ????????? ? ????????? ??????. Basic Qualifications • ??????????? - ?????? ? ??????? ???????? ?/??? ???????. • ????????? ???? ? ???????????????? ??????? ?? 2-? ???. • ?????? ???????????, ???????, ?????????, ???????????. • ????????? ?? ?????????? ????????????? ?????? ???????????. • ?????? ?? ???????????? ?????????? – ??????? ???????????? MS Office for Windows, Microsoft PowerPoint Presentation . • ??????? ????????????? ????????????? ? ???????????? ?????? ???????? ??????????. • ???????????? ???? ?? ????? 1 ????.2012-04-19 20:56:05RussiaAmgenNone15414BRNoneField Based, RUS28013713http://www.amgen.jobs/xml/28013713/jobUSAThousand OaksAuto req 15406BR Job Posting Title Business Analysis & Info Sr Mgr, Oncology Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description BAI Senior Manager, Primary and Secondary Market Research, and Competitive Intelligence This Business Analysis & Information (BAI) team member is assigned to support an Amgen Therapeutics global franchise. This person will: • Create productive relationships with assigned Global marketing teams to define business priorities and orchestrate the collection, analysis, and communication of market research and strategic insights • Apply structured problem solving approaches to key competitive questions, working with BAI colleagues to integrate results from other BAI disciplines, e.g. competitive intelligence, forecasting and inline products • Independently plan, design, and conduct multiple simultaneous complex projects in support of the global strategic plans, proactively defining the critical path, anticipating potential obstacles, and recommending actions to keep projects on track • Manage external vendors and consultants to enable effective project execution • Provide competitive business insights based on project results with actionable recommendations to brand/business stakeholders • Ensure that both routine and ad-hoc projects meet service-level expectations for quality, timeliness, and budget • Some travel required to supervise market research and attend key meetings, etc. • The candidate should expect to make a 18-24 month commitment to this role. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience Preferred Qualifications • Advanced degree (MS/MBA/PhD) preferred. • 7-10 years experience across all aspects of primary market research and secondary data (both inline and pipeline)in the biopharma or related healthcare industries. • Experience within the oncology therapeutic areas, with established networks (suppliers, thought leaders, practitioners, etc.), understanding of the evolving market dynamics, and familiarity with key competitors (activities, strategic intent, views, assumptions) • Excellent oral, written and presentation skills • Strong project management skills. • Demonstrated analytical skills with a client service orientation. • Ability to work collaboratively in a team environment.2012-04-19 20:55:53United StatesAmgenCalifornia15406BRCAThousand Oaks, CA28013707http://www.amgen.jobs/xml/28013707/jobFRANeuilly-sur-SeineAuto req 15393BR Job Posting Title Admin Coordinator Career Category Administrative Employee Subgroup Salaried FT Country (State/Region) France Location (City) Neuilly-sur-Seine Amgen Job Description Chez Amgen, notre vocation est d’être la meilleure entreprise pharmaceutique de biotechnologie, en utilisant la science et l’innovation afin d’améliorer significativement la vie des patients atteints de pathologies lourdes et invalidantes. Entreprise dynamique née dans les années 1980 aux Etats-Unis, Amgen a su se développer et s’implanter dans le monde entier. En moins de vingt ans, notre filiale française a vu croître parallèlement son chiffre d’affaires et ses effectifs. Aujourd’hui, ses 350 collaborateurs sont fiers de son statut de première filiale Européenne et de l’image dont elle bénéficie dans le monde de l’industrie pharmaceutique. Chez Amgen, vous travaillerez avec des collaborateurs performants et des leaders exemplaires, dans une culture imprégnée par nos valeurs. Notre entreprise a de belles réussites à son actif, une réelle volonté de développement et un avenir prometteur. Les Missions Rattaché(e) au Directeur de la Business Unit Néphrologie & Rhumatologie, vous travaillerez en étroite collaboration avec le Directeur des Ventes et le Responsable Marketing. - Assistanat des Ventes Vous assurez la coordination logistique de différents types d’évènements (congrès, formation, mi-cycle…) en collaboration avec les équipes respectives. Vous êtes l’interlocuteur privilégié des Attachés Scientifiques pour toutes demandes ad’hoc (procédures, matériel promotionnel…) Vous élaborez les calendriers, les plannings et les agendas en fonction des spécificités de chaque département - Assistanat Marketing Vous assistez le chef de produit et la responsable marketing dans la préparation des campagnes : gestion des relations avec l’agence, gestion des impressions, suivi des livraisons, suivi des validations de relecture des documents promotionnels. Vous gérez les contrats et suivez le paiement des orateurs en collaboration avec le département « Compliance ». - Support BU Vous créez et suivez les demandes d’achat Vous organisez les réunions internes & externes (webex, confcall, ordre du jour & compte rendu) Basic Qualifications Votre Profil De niveau Bac/BTS en Gestion/Secrétariat commercial, vous justifiez de préférence d'une première expérience de minimum 3 à 5 ans dans un service Marketing / Communication / Vente dans un environnement dynamique. Vous maîtrisez les outils informatiques, la connaissance de SAP© est un plus. Outre l'autonomie, la grande rigueur et la gestion des priorités dont vous faites preuve dans votre travail quotidien, votre efficacité, votre flexibilité et l'esprit d'équipe qui vous anime feront de vous un interlocuteur privilégié au sein d'une équipe dynamique. Preferred Qualifications Si vous êtes en situation de handicap, n’hésitez pas à informer votre interlocuteur des Ressources Humaines de toute adaptation ou outil nécessaire au bon déroulement de l’entretien.2012-04-19 20:55:49FranceAmgenNone15393BRNoneNeuilly-sur-Seine, FRA28013700http://www.amgen.jobs/xml/28013700/jobUSAThousand OaksAuto req 15426BR Job Posting Title Medical Writing Mgr Career Category Medical Affairs Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen is seeking a Medical Writing Manager for their Scientific Affairs Cardio/Renal area. This is a full-time, Thousand Oaks, CA corporate office-based position. Consider joining a team that communicates the results of Amgen's research to the scientific community and embraces Amgen's aspiration to be the world's best human therapeutics company. As key members of North American Medical Teams, Amgen's Scientific Affairs medical writers work closely with authors to develop manuscripts and review articles for peer-reviewed clinical journals as well as abstracts, posters, and slide presentations for scientific congresses. In addition to providing strategic input to product publication teams and scientific congress planning teams, Scientific Affairs writers liaise with medical leads, biostatisticians, safety experts, and health economists as well as external opinion leaders, clinical investigators, and journal editors. Additional responsibilities may include the following: •Preparing or editing documents for submission to external regulatory agencies •Preparing or editing internal documents requiring robust scientific summaries •Writing, rewriting, performing QC checks, or editing materials for product dossiers •Conducting literature searches, reviewing pertinent literature, and preparing summaries or abstracts, as required •Attending scientific congresses and writing daily and post-meeting summaries Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications •Doctorate degree •Previous medical writing experience in a biotech or pharmaceutical company, or previous postdoctoral research in the cardio/renal area •Experience analyzing and communicating scientific data in peer-reviewed journal publications and in abstracts and presentations at scientific congresses •Proficient in pertinent software (eg, MS Office, EndNote, Adobe Illustrator) •Knowledge of publication guidelines and best practices •Superb written and verbal communication skills •Experience working independently under limited supervision •Ability to apply project management skills to advance numerous projects simultaneously •Ability to work in a matrixed team environment •Ability to lead and/or facilitate effective team meetings2012-04-19 20:55:47United StatesAmgenCalifornia15426BRCAThousand Oaks, CA28013697http://www.amgen.jobs/xml/28013697/jobNLDBredaAuto req 15370BR Job Posting Title Regional Medical Liaison Career Category Sales & Marketing Operations Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Field Based Amgen Job Description Key Activities - Supports Head Regional Medical Liason (RML)/local Therapeutic Area (TA) Leader in developing local territory R&D tactics - Identifies, develops and maintains collaborative relationships with current and future Key Opinion Leaders (KOLs), scientific experts, cooperative study groups and study sites - Develops and implements local KOL Plans, in line with local and international KOL strategy - Creates end execute engagement plans - Implements and disseminates high quality medical and scientific educational programs; gives clinical and scientific presentations at sites / hospitals - Identifies new research opportunities, implements and follows up on ISSs and other scientific activities, provides input to the design of local observational research - Works with development field operations to ensure prioritization of site selection, and support feasibility across assigned territories - Supports ASTs on site with scientific presentations/discussions to create enthusiasm for the scientific program, understand trial/referral networks and identify enrollment barriers, participates in investigator meetings according to approved investigator strategy - Represents Amgen Medical department in the territory - Ensures society engagement: RML support of international and regional congresses - Develops required qualitative and quantitative reports; collates competitor information - Ensures conduct of work in line with compliance regulations - Delivers targeted internal training for selected topics (e.g. study update, congress news, latest scientific developments) Reports (at a minimum) to: Local Head RML or local TA Lead Responsible for: - Execution of RML Plan Of Actions - Scientific relationships in a set territory - KOL profiles, plans and reports - Engagement plans - Protocol proposals and other study documents for local ISSs - Territory input for feasibility and site selection - Scientific study site support for ASTs - Educational programs to change medical practice - Scientific presentations to physicians and hospital departments - Field feedback: scientific trends, ongoing studies, CI - RML activity tracking PLEASE NOTE: An Amgen year contract is offered for this position Basic Qualifications - Medical or scientific education or experience from similar positions - Minimum 3 years of experience in industry, or a related scientific field in academia - Experience in sales force, affiliate Medical Department or Clinical Development - Willingness to travel; possesses valid driver’s license - Experience with clinical study management and conduct - Scientific expertise in the therapeutic area - Knowledge of commercialization and business practices - Knowledge of regulatory affairs, drug safety, legal and compliance environment - Network of customer contacts - Medical / scientific research experience - Fluency in English and Dutch language is required for this role Preferred Qualifications - Advanced degree (e.g. PhD , MD) preferred or strong demonstration of equivalent combination of relevant educational and professional training2012-04-19 20:55:12NetherlandsAmgenNone15370BRNoneBreda, NLD28013663http://www.amgen.jobs/xml/28013663/jobUSAThousand OaksAuto req 15384BR Job Posting Title Biostatistical Programming Mgr Career Category Scientific Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Manager Statistical Programming will work in Amgen's Global Safety & Independent Biostatistics (GSIB) organization Programming team in the Cardiac-renal and General Medicine Therapeutic area • Function as product lead programmer on one or more programs of clinical trials across phases I – IV and observational research studies: o Lead a programming team in Global Safety & Independent Biostatistics (GSIB) for safety-related programming activities on multiple products, define roles and responsibilities of the programming team members, ensure the analysis and presentation of clinical trial safety data are accurate and complete according to agreed resource and timeline plans; o Provide programming support to proactive safety surveillance and signal detection based on clinical trial safety data for the covered products; o Contribute to key safety-related updates - Development Safety Update Reports (DSUR), Risk Management Plan (RMP), Investigational Brochure (IB), and Periodic Safety Update Reports (PSUR), by providing programming support on clinical trial safety data processing and table/figure/listing(TFL) generation and validation; o Plan and support Data Review Team (DRT)-related programming activities and processes at study or protocol level; o Adhere to Amgen Policies, Standards of Process (SOPs) and other standards for all programming activities in the covered products; o Participate in statistical programming process and system audits by Amgen Global Compliance Auditing (GCA) and external bodies, and respond to audit questions and findings. • Provide technical leadership, supervision and technical solutions to programming issues within the product team; • Ensure best programming practice through leadership of programming process improvement initiatives; • Lead and develop technical programming and process improvement initiatives within the product team; • Represent the product programming function and, as required, participate in multidisciplinary project team meetings; • Write, review and approve analysis dataset specifications within product team; • Write, test and validate software programs (including utilities and toolbox) to produce analysis datasets and TFLs for deliverables; • Lead or participate in the development of Amgen Policies, SOPs and other controlled document development; • Participate in the recruitment of programming staff within GSIB, support and mentor junior programmers, manage and develop programming staff or consultants; • Contribute to process improvement and operational efficiency of Global Biomedical Data Sciences (GBDS) and Global Biostatistic Science (GBS); • Collaborate closely with GSIB Biostatisticians, other product leads within GBDS and other functional teams; • Promote and communicate awareness of the role and function of GSIB and communicate to business partners and colleagues. Basic Qualifications Minimum 6 years relevant career experience in the pharmaceutical or biotechnology industry, with at least a BS degree in Statistics, Life Science, Computer Science, Mathematics, or other relevant scientific subjects (directly related experience should include the management of people and/or experience of leading project teams, drug development programs and/or directing the allocation of programming resources) Knowledge: • Biostatistical programming using the SAS System version 9.1.3 or higher; • Understanding of computer operating systems, including UNIX preferred; • Project planning and management; • Drug development process & operations, and drug safety analysis & reporting; • Experience of working within a global team. Preferred Qualifications • Minimum 6 years relevant career experience in the pharmaceutical or biotechnology industry, with at least a BS degree in Statistics, Life Science, Computer Science, Mathematics, or other relevant scientific subjects; • Knowledge of biostatistical programming within drug development industry, knowledge of drug development process and operation, and drug safety analysis and reporting; • Project management skills - ability to plan and manage projects, to allocate team work on complex tasks , to lead a project successfully from programming set-up to completion, and deliver according to agreed timelines; • Communication skills - the ability to communicate effectively within a team and across functions.2012-04-19 20:55:12United StatesAmgenCalifornia15384BRCAThousand Oaks, CA28013661http://www.amgen.jobs/xml/28013661/jobUSAThousand OaksAuto req 15192BR Job Posting Title Global Safety Sr Mgr Career Category Safety Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description To focus on device-related safety activities for one or more programs. To be subject matter expert in Amgen Global Safety for activities related to drug delivery device and combination product safety; establishment and execution of procedures and best practices related to device/combination product development and commercialization with respect to safety. To interface as device safety expert across multiple Amgen functional areas including Therapeutic Area Safety, Global Development, Safety Operations, Device Regulatory, Device Quality, and Drug Delivery Division. Job Summary: The Global Safety Scientist – Device, will conduct activities related to device safety by providing technical expertise and support to the Global Safety Officer (GSO) and Global Safety Team (GST) for product-associated drug delivery devices. Working under the supervision of the CMC Safety Executive Director and product GSO, will be responsible for device-product combination safety-related evaluations and deliverables for assigned products, worldwide. Key Activities: ?Work closely with the GSO and fully participate in GST activities related to device safety ?Support GSO and GST in specific device development safety activities and clinical interpretation of device associated safety data ?Contribute to the establishment of critical procedures and best practices related to device/combination product development and commercialization with respect to safety ?Provide content support for device/combination product evaluation activities including MDR assessments, signal detection, quality monitoring and hazard evaluations, and risk management ?For assigned products, serve as the device safety representative at selected internal meetings with collaborating Departments Knowledge and Skills ?Clinical device safety and pharmacovigilance ?Knowledge of clinical trials and device development ?Knowledge of Quality Management Systems, global safety reporting requirements, and risk management for medical devices ?Knowledge of therapeutic adra patient populations in relatin to drug-device combination products ?Familiarity with signal recognition and safety evaluation techniques ?Knowledge of global safety requirements for worldwide pharmacovigilance, especially as related to medical devices ?Excellent interpersonal and teamwork skills ?Microsoft Suite – Outlook, Word, Excel, PowerPoint ?Critical scientific thinking and problem solving ?Attention to detail ?Organizationally savvy in a matrix environment ?Time management skills ?Communication skills: presentation and medical writing ?Issue and conflict resolution Basic Qualifications ?Doctorate degree and 2 years of directly related experience OR ?Master’s degree and 6 years of directly related experience OR ?Bachelor’s degree and 8 years of directly related experience OR •Associate’s degree and 10 years of directly related experience OR •High school diploma / GED and 12 years of directly related experience Preferred Qualifications ?Drug safety, biotech/pharmaceutical or regulatory agency experience (drug delivery/combination product experience) ?Advanced scientific degree (Ph.D. or Pharm. D.) or MD or DO degree from an accredited medical school; or background in medical device development, engineering, clinical or pharmaceutical industry experience If non-physician: ?Demonstrated scientific training OR ?Clinical experience in activities relevant to utilization of medical devidces, especially as related to drug delivery If physician: ?Completion of an accredited medical or surgical residency OR ?Clinical experience in either an accredited academic setting or private practice (including hospital based) setting2012-04-19 20:54:33United StatesAmgenCalifornia15192BRCAThousand Oaks, CA28013635http://www.amgen.jobs/xml/28013635/jobUSAThousand OaksAuto req 15418BR Job Posting Title Scientist (Cell Sciences & Technology) Career Category Process Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Cell Science and Technology department is recruiting a Scientist (PhD.) level researcher within the cell line development and engineering functional area. The successful candidate will become a key member of a team focused upon the development of production cell lines for Amgen's large molecule biotherapeutic pipeline. The successful candidate will help direct lab personnel in both cell line and technology development programs. This team member will work towards the continued development of new, cutting-edge technologies to enhance outcomes and improve current scientific understanding, directed towards improving production cell line development and performance; with yield, speed, and efficiency in mind. The Scientist will enhance and improve established platform approaches and utilize solid problem solving skills as well as out-of-the-box thinking to deliver technology improvements. Basic Qualifications - Doctorate degree (or finalizing PhD by July 2012) OR - Master’s degree & 6 years of scientific experience OR - Bachelor’s degree & 8 years of scientific experience Preferred Qualifications - Ph.D. in molecular / cell biology or associated life science, combined with experience related to or directly applicable to bioprocess development and cell line generation. - Strong molecular biology skills are essential together with expertise in mammalian cell culture, in particular stable cell line generation and clone screening. - Expertise in transcriptomics or similar ‘omics’ technologies and/or current gene knockout technologies highly advantageous. - Proven interdisciplinary project management skills - A track record in resolving and overcoming issues associated with the cell line development process and associated technologies - Recognized in the scientific community through a record of publications and/or patents - Previous experience in the biotechnology area related to bioprocess and cell line development - Solid scientific understanding of cell line development and associated technologies - Strong mentoring capabilities, data driven decision-making and project management skills to help drive the team towards new performance levels. - Demonstrated independence, innovation and a strong track record of success2012-04-19 20:53:40United StatesAmgenCalifornia15418BRCAThousand Oaks, CA28013402http://www.amgen.jobs/xml/28013402/jobUSAThousand OaksAuto req 15369BR Job Posting Title Sr Scientist (Cell Sciences) Career Category Process Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Seeking a highly motivated and independent individual that will lead a team responsible for the development, optimization, scale-up and transfer of mammalian cell culture processes to support early and late stage pipeline projects. Lead the overall strategy in the planning, design and execution of experiments that successfully meet project timelines and goals. Need to be very hands-on with bioprocess operation and adept in resolving equipment issues. Work cross-functionally with various groups such as analytical science, purification, pilot plant, and process engineering to leverage resource and support to efficiently and effectively deliver on project milestones. Author development reports, regulatory filings, and scientific publications. Champion and implement continual improvements to the cell culture platform process. Explore, develop, and implement new cutting-edge cell culture technology that can significantly improve development efficiency, process productivity, and reduce cost. Act as a scientific resource for the department and for junior members of the group. Ability to initiate, influence, and lead new scientific projects with clear scope to successful completion. Keep up-to-date with the current trends of technology and abreast of scientific publications. Basic Qualifications - Doctorate degree & 2 years of scientific experience OR - Master’s degree & 8 years of scientific experience OR - Bachelor’s degree & 10 years of scientific experience Preferred Qualifications - Ph.D. in chemical engineering, biochemical engineering, bioengineering or biochemistry - 3+ years experience post Ph.D. in a bioprocess development industrial environment - Knowledge of license applications and the drug development process - Familiar with all aspects of cell culture process development including clone screening, bioreactor optimization, medium development, scale-up and process transfer - Need to have worked with small-scale bioreactor models, single-use bioreactors, disposables, high-throughput technology, and had experience supporting GMP manufacturing and troubleshooting large-scale production - Deep understanding of cell biology, metabolism, product quality attribute effect is strongly desired - Routine use of statistical modeling and analysis of experimental data is required. Knowledge of VBA for Excel is desired. - Managerial experience of progressively increased scope - Strong project management and interpersonal skills2012-04-18 18:41:30United StatesAmgenCalifornia15369BRCAThousand Oaks, CA27978714http://www.amgen.jobs/xml/27978714/jobUSAThousand OaksAuto req 15380BR Job Posting Title Clinical Research Medical Director - Nephrology Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Clinical Research Medical Director is responsible for: - Supporting the development, execution and communication of the global scientific/medical evidence plan - Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program - Supporting the development of key scientific external relationships with opinion leaders - Participating and providing clinical input into safety and regulatory interactions Key Activities: - Provide clinical/scientific input during the development and execution of clinical trials - Interpret clinical trial data - Participate in safety assessments - Participate in interactions with regulatory agencies - Author CSRs, publications and regulatory submissions - Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL - Identify new clinical research opportunities - Support in-licensing and out-licensing activities and partner relationships - Support product lifecycle management for new indications as directed by Global Development Leader - Provide clinical content input to: - Regulatory interactions and documents - Safety interactions and documents - Materials to be used in Scientific Affairs - Materials to be used by the Commercial Organization Basic Qualifications - MD - Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Preferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent - Experience in Nephrology - Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities - Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) - prior clinical research in Nephrology Knowledge - In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale - Familiarity with concepts of clinical research and clinical trial design, including biostatistics - Sound scientific and clinical judgment - Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements - Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication - Demonstrated ability as a medical expert in a complex matrix environment - History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues2012-04-18 18:41:01United StatesAmgenCalifornia15380BRCAThousand Oaks, CA27978706http://www.amgen.jobs/xml/27978706/jobUSAField BasedAuto req 15249BR Job Posting Title Sr Biopharmaceutical Rep, Inflammation - Norhtern Indiana Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Indiana Location (City) Field Based Amgen Job Description Territory - #34511 Norhtern Indiana As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-04-17 20:12:46United StatesAmgenIndiana15249BRINField Based, IN27953387http://www.amgen.jobs/xml/27953387/jobDNKCopenhagenAuto req 14588BR Job Posting Title Administrativ Coordinator Career Category Administrative Employee Subgroup Salaried FT Country (State/Region) Denmark Location (City) Copenhagen Amgen Job Description For our Danish office in Hellerup, we are looking to fill a vacancy for the position as Administrative Coordinator supporting the Country Director and their teams. Key Activities: •Initiating/facilitating/participating in cross-functional team meetings •independently coordinating web-interface meetings •Developing slide presentations. •Assisting with special projects as requested by the Directors and others within group. • Maintain distribution, contact and personnel lists • Coordinate mailings and courier/deliveries • Coordinate functional processes such as invoicing and payments in SAP • Manage the administrative aspects of relationships with outside experts and vendors • Participate in department project teams • Provide backup support to additional department ACs • Update and maintain all dues, memberships, subscriptions etc. This role will leverage an experienced AC who enjoys working in a fast-paced environment, and can ensure timely coordination of the Country Director and Sr. Managers below listed administrative needs. You will also manage individual and team calendars (Outlook), and coordinate local and international meetings such as arrange travel, prepare agendas and have an overall responsibility. Basic Qualifications Prefered qualifications: • 5 years of experience in an administrative support role supporting large teams at different levels • Advanced computer system knowledge, previous experience with SAP and SharePoint is a plus •Experience providing administrative support to remote staff •Outstanding organizational and interpersonal skills •Ability to work in a fast-paced ,deadline- driven environment •Discretion in dealing with proprietary information Preferred Qualifications This role will require the employee to be flexible, take initiative and work well independently as well as in teams. This role will proactively anticipate needs, communicate expectations, disseminate and compile information. We are also looking for an individual who is detail-oriented, able to work on multiple projects simultaneously and organize and prioritize workflow. You will be required to be able to handle sensitive and confidential information with diplomacy and discretion. Another important skill you must have in order to be successful in this role is to be able to effectively communicate, both orally and in writing both in Danish and English. You will also demonstrate a service-oriented approach to all activities, a willingness to learn new approaches and adapt to change, and will lead by example in promoting teamwork. What we offer you: We can offer you a full time, permanent position in a creative, challenging and international environment with a broad range of work duties and responsibilities. As a part of Amgen International you get training within our international training and development program. We are looking for a person that can start working as soon as possible. The position is based in our office in Hellerup, Denmark. For more information about the position, contact Eleonore Hassila, HR Department on +46 8 695 11 00 or eleonore.hassila@amgen.com. To apply for this position go to www.amgen.com/careers and search for Requisition number 14588BR, no later than May 11th.2012-04-17 20:12:44DenmarkAmgenNone14588BRNoneCopenhagen, DNK27953384http://www.amgen.jobs/xml/27953384/jobUSAThousand OaksAuto req 15148BR Job Posting Title Sr Mgr Biostatistics Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description •implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis •Plan and execute statistical contributions to Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications •Complete statistical analysis of multiple studies/projects •Hire, manage and develop statistical staff •Contribute to resource and budget planning •Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings) •Be familiar with statistical policy and strategy at Amgen •Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field •Promote and communicate statistical awareness and the role of the Global Biostatistics department, and may contribute to statistical consultancy, statistical training and expert advice within Global Biostatistics and within Amgen •Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents •Participate in study and systems audits conducted by Amgen CQA and external bodies, and respond to audit questions and findings •May lead and/or participate in change / process improvement initiatives •May participate in external activities (e.g. Industry, academic) Basic Qualifications .Doctorate degree & 2 years of directly related experience OR .Master’s degree & 6 years of directly related experience OR .Bachelor’s degree or & 8 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience AND .2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Minimum 8 years relevant career experience in the pharmaceutical/biotechnology industry, with Bachelor’s degree (MS/MA degree preferred) in Biostatistics, Statistics, Computer Science, Mathematics, Life Sciences, or other relavent scientific subject Strong project planning and management skills - the ability to lead and manage cross-functional projects from concept to completion, being proactive and taking initiative, striking balance between strategic and tactical thinking, the ability to handle complex tasks, and deliver according to agreed timelines Strong verbal and written communication skills - ability to clearly and effectively present information, demonstrate creativity and foresight in anticipating and solving complex project issues Displays personal ownership - a natural innovator who is always looking for opportunities to improve systems or processes Track record of generating new ideas and solutions to business problems, and the vision and tenacity to translate that vision into quantifiable results Takes steps to ensure the ongoing technical development2012-04-17 20:12:41United StatesAmgenCalifornia15148BRCAThousand Oaks, CA27953376http://www.amgen.jobs/xml/27953376/jobUSAField BasedAuto req 15282BR Job Posting Title Sr Biopharmaceutical Rep, Inflammation - Southern Arizona Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Arizona Location (City) Field Based Amgen Job Description Territory - #36213 Southern Arizona As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-04-17 20:10:46United StatesAmgenArizona15282BRAZField Based, AZ27953273http://www.amgen.jobs/xml/27953273/jobUSAField BasedAuto req 15256BR Job Posting Title Sr Biopharmaceutical Rep, Inflammation - Houston NE, TX Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Texas Location (City) Field Based Amgen Job Description Territory #35113 - Houston NE, TX As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-04-17 20:10:23United StatesAmgenTexas15256BRTXField Based, TX27953256http://www.amgen.jobs/xml/27953256/jobUSAField BasedAuto req 15281BR Job Posting Title Sr Biopharmaceutical Rep, Inflammation - Nothern Arizona Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Arizona Location (City) Field Based Amgen Job Description Territory - #36212 Nothern Arizona As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-04-17 20:09:05United StatesAmgenArizona15281BRAZField Based, AZ27953149http://www.amgen.jobs/xml/27953149/jobUSAField BasedAuto req 15291BR Job Posting Title Sr Biopharmaceutical Rep, Inflammation - Tacoma, WA - Alaska Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Alaska United States - Washington Location (City) Field Based Amgen Job Description Territory - #36513 Tacoma, WA - Alaska As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-04-17 20:08:59United StatesAmgenAlaska15291BRAKField Based, AK27953140http://www.amgen.jobs/xml/27953140/jobUSAThousand OaksAuto req 14527BR Job Posting Title Corporate Communications Director, Global Commercial Operations Career Category Corporate Services Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Corporate Communications Director - Global Commercial Operations (GCO) is responsible for developing and executing internal communications strategies and plans that drive staff awareness of and engagement with the business goals, strategies and performance of the GCO organization and Amgen. This individual will also provide communications counsel and tactical support around organizational change and key business initiatives. S/he will work directly with the executive vice president of GCO and members of his leadership team in this high impact role. The GCO function encompasses Amgen’s marketing, sales and commercial operations around the world, including the United States, Europe, Asia, Latin America and emerging markets. Reporting to the Executive Director, Internal & Executive Communications, this individual will work with colleagues in Global Communications to develop communications strategies, tactics and messages that will be leveraged across functions and geographies. Responsibilities Include: • Work directly with the executive vice president of GCO to address his internal communications needs. Provide counsel and develop content for his face-to-face meetings, presentations, panel discussions, webcasts, videos, town halls, intranet news articles, electronic discussion forums, blogs, emails, and voicemails • Develop communications strategies and plans that help GCO teams effectively, consistently, and ethically communicate to their key stakeholders across geographies; flawlessly execute on those plans and deliver measurable results • Serve as the Global Communications representative on internal project teams focused on continuous improvement efforts or evolving business developments • Work in partnership with key, cross-site/cross-function internal and external communication professionals to ensure awareness of key company and Global Commercial Operations initiatives, milestones and news • Measure the results of communications tactics and plans and adapt future plans for continuous improvement. • Some travel may be required Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience Preferred Qualifications • Top-performing communications professional with demonstrated expertise in corporate communications in the biotechnology / pharmaceutical industry • Results-driven self-starter with the ability to influence others • Experience developing communications strategies and tactics for a sales & marketing function and a proven ability to help senior executives communicate in a clear and compelling manner to engage and influence staff • Internal/external communications leadership for transformational organizational changes • Ability to work on complex and sensitive information, manager a number of programs and projects simultaneously, and deliver and excel under tight deadlines • Understanding of the regulations and environment regarding sales & marketing activities in the biotechnology/pharmaceutical industry • Excellent writing/presentation skills • Excels in highly-matrixed environments • Demonstrated ability to build consensus among diverse leaders and manage sensitive situations • Active listening skills and ability to quickly and effectively incorporate feedback2012-04-17 20:08:58United StatesAmgenCalifornia14527BRCAThousand Oaks, CA27953139http://www.amgen.jobs/xml/27953139/jobSVKBratislavaAuto req 15358BR Job Posting Title Regulatory Affairs Sr Mgr Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) Slovak Republic Location (City) Bratislava Amgen Job Description Being the primary point of contact for regulatory authority (ies) in large country. Obtaining and maintaining local product and pharmaceutical company licenses. Senior contact point for any regulatory advice for commercial and medical projects within country/sub-region. Translates global and international business plans to local regulatory and quality objectives Representing Compliance and Regulatory on the management team of a small/medium country Ensuring that local processes, strategies and initiatives are aligned with regulatory requirements defined by Amgen International and Global groups. Overseeing the affiliate compliance framework to comply with Local Code & legislation & Amgen Policies and procedures Identifying the need for country specific compliance procedures and overseeing their development and implementation Providing senior level regulatory expertise into International regulatory affairs group. Basic Qualifications Qualifications Degree in scientific discipline Advanced degree or MBA advantageous Fluency in local language plus English   Experience Significant directly related experience in regulatory and compliance areas Regulatory expertise in national, MRP, centralised and biotechnology products Knowledge of quality systems Line management experience Building relationships with regulatory authorities Defining and implementing policies, procedures and SOP’s Working with country senior management teams Knowledge Expert knowledge of national legislation and regulations relating to medicinal products In-depth knowledge about the registration procedures in Europe (Centralised, Mutual recognition and Decentralised) for MAA, variations, extensions and renewals. Knowledge about the technical requirements for registration of biotechnology products.2012-04-17 20:08:54Slovak RepublicAmgenNone15358BRNoneBratislava, SVK27953131http://www.amgen.jobs/xml/27953131/jobPRTLisbonAuto req 15368BR Job Posting Title Regional Medical Liaison (Temporary) Career Category Medical Services Employee Subgroup Salaried FT Country (State/Region) Portugal Location (City) Lisbon Amgen Job Description Due to a maternity leave, we are urgently looking to hire an RML for the nephrology therapeutic area, with a temporary contract. The person will report to the Medical Development Senior Manager, office based in Lisbon. The purpose of this role is: To maximize Amgen’s value propositions to create value for patients through medical and scientific projects, services and expertise, with key scientific customers (according to Iinternational R&D strategies) within Nephrology therapuetic area To implement scientific programs in local territories in collaboration with District Sales Manager and Development Field Operations The candidate's main responsibilities will be: Execution of RML POA Scientific relationships in a set territory KOL profiles, plans and reports Protocol proposals and other study documents for local ISSs Territory input for feasibility and site selection Scientific study site support for ASTs Educational programs to change medical practice Scientific presentations to physicians and hospital departments Field feedback: scientific trends, ongoing studies, CI RML activity tracking Key activities: Supports Head RML/local Therapeutic area Leader in developing local territory R&D tactics Identifies, develops and maintains collaborative relationships with current and future KOLs, scientific experts, cooperative study groups and study sites Develops and implements local KOL Plans, in line with local and international KOL strategy Creates end execute COER engagement plans Implements and disseminates high quality medical and scientific educational programs; gives clinical and scientific presentations at sites / hospitals Identifies new research opportunities, implements and follows up on ISSs and other scientific activities, provides input to the design of local observational research Works with development field operations to ensure prioritization of site selection, and support feasibility across assigned territories Supports ASTs on site with scientific presentations/discussions to create enthusiasm for the scientific program, understand trial/referral networks and identify enrollment barriers, participates in investigator meetings according to approved investigator strategy Represents Amgen Medical department in the territory Ensures society engagement: RML support of international and regional congresses Develops required qualitative and quantitative reports; collates competitor information Ensures conduct of work in line with compliance regulations Delivers targeted internal training for selected topics (e.g. study update, congress news, latest scientific developments) Basic Qualifications Minimum of 3 years of experience in industry, or a related scientific field in academia, including at least 1 year in a similar position. Experience in sales force, affiliate Medical Department or Clinical Development Willingness to travel; possesses valid driver’s license Experience with clinical study management and conduct Scientific expertise in the therapeutic area Native Portuguese and intermediate level of English Preferred Qualifications Knowledge of commercialization and business practices Knowledge of regulatory affairs, drug safety, legal and compliance environment Network of customer contacts Medical / scientific research experience2012-04-17 20:08:44PortugalAmgenNone15368BRNoneLisbon, PRT27953111http://www.amgen.jobs/xml/27953111/jobUSAField BasedAuto req 15251BR Job Posting Title Sr Biopharmaceutical Rep, Inflammation - Central Illinois Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Illinois Location (City) Field Based Amgen Job Description Territory #34513 - Central Illinois As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-04-17 20:07:56United StatesAmgenIllinois15251BRILField Based, IL27953087http://www.amgen.jobs/xml/27953087/jobUSAField BasedAuto req 15331BR Job Posting Title Sr Biopharmaceutical Rep, Inflammation - Naperville, IL Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Illinois Location (City) Field Based Amgen Job Description Territory #34112 Naperville, IL As a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Basic Qualifications Bachelor’s degree & 2 years of sales experience OR Associate’s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact2012-04-17 20:07:51United StatesAmgenIllinois15331BRILField Based, IL27953082http://www.amgen.jobs/xml/27953082/jobUSAThousand OaksAuto req 15089BR Job Posting Title Principal IS Architect (Enterprise IS Technology Services Principal Design Engineer) - Networking Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Job Summary The Principal Design Engineer for Enterprise IS Technology Services Design Engineering (EISTS) is responsible for the development, delivery, and life cycle of Amgen IS Infrastructure technologies in networking, firewalls, switches, circuits, VPN, telephony, and all related areas. As a multi-disciplinary expert, the Principal Design Engineer must provide Engineering direction across the organization in their areas and relationships to it from other areas. This position will deliver timely designs and implementations from the existing technology portfolio, create new solutions, and maintain the technology portfolio life cycle. Job Responsibilities • Be accountable for developing, delivering and maintaining an integrated set of designs, detailed specifications, roadmaps and program delivery for solutions from their areas. • Ensure the relevance and completeness of designs and delivered solutions to EISTS service owners. • Accountable to ensure IS projects leverage and maximize value Engineered solutions from their portfolio of technologies through strong collaboration within EISTS and across IS. • Provide technical leadership and implementation support to projects requiring cross-functional integration expertise, including co-development of project plans. • Lead the introduction of new EISTS Technologies into their portfolio to enable business value driven innovation while maximizing organizational effectiveness and efficiency. • Maintain the technology portfolio life cycle for their areas within EISTS, including driving the retirement of obsolete or declining technologies and delivery of successor technologies to enable efficient service provision and minimize risks. • Lead alignment of services and operations for their areas within EISTS, to increase efficiency and reduce the risk of unmanaged faults in the service and operational pipeline. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Master’s degree • Bachelor’s Degree in Information Systems, Computer Science, or Electronics • 10 + years experience working within Information Systems • 7+ years experience delivering large and small IS infrastructure technology solutions in global companies using Information Technology and Services in regulated environments. Additional experience with technology supply and sourcing companies a plus. • 5+ years developing integrated business-to-business and business-to-consumer solutions, including detailed technical experience with all facets of network technologies and all related systems including experience implementing and administrating common TCP/IP-based services, including DNS, DHCP, HTTP, FTP, SSH, SMTP, etc. • 5+ years experience with service design and operational alignment. Specific experience applying ITIL to infrastructure service delivery and operation is a plus. • 5+ years biotechnology or pharmaceutical experience are a plus. • Strong leadership and communication skills to convince all stakeholders on programs and portfolio investments. • The ability to function in multiple roles based on project demands. • Strategic delivery experience and ability to facilitate alignment and investment across multiple geographies, functions, and disciplines. • Excellent oral, written and interpersonal communication skills. • Experience with a range of IT service, architecture, engineering, and design frameworks and languages, including UML and/or BPMN a plus. • This position requires a senior and credible IS Infrastructure technology design and delivery engineer, with broad experience and demonstrated success. It requires a passion for Information Technology and engineering, in depth understanding of Infrastructure technologies, of technology integration, and of industry practices. • Learning agility, technical excellence, discipline and the capability to engage and collaborate across the IS Function in a relationship based organization to drive change and continuous improvement at all levels are essential attributes. • This individual will leverage his/her extensive experience in designing and delivering global information infrastructure systems in a regulated environment for the Enterprise and a diverse range of specialized business needs and partner with business IS and other Enterprise shared services2012-04-16 20:54:23United StatesAmgenCalifornia15089BRCAThousand Oaks, CA27929900http://www.amgen.jobs/xml/27929900/jobUSAThousand OaksAuto req 15338BR Job Posting Title Medical Writing Mgr Career Category Medical Services Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen, the world's largest biotech company, discovers, develops, and delivers innovative human therapeutics to treat grievous illnesses, such as kidney failure, cancer, rheumatoid arthritis, psoriasis, and osteoporosis. Headquartered in Southern California, Amgen is consistently rated as one of the best places to work and offers competitive compensation and terrific opportunities for the development of its employees. Amgen is seeking a Medical Writing Manager for their Scientific Affairs Metabolic Bone area. This is a full-time, Thousand Oaks, CA corporate office-based position. Consider joining a team that communicates the results of Amgen's research to the scientific community and embraces Amgen's aspiration to be the world's best human therapeutics company. As key members of North American Medical Teams, Amgen's Scientific Affairs medical writers work closely with authors to develop manuscripts and review articles for peer-reviewed clinical journals as well as abstracts, posters, and slide presentations for scientific congresses. In addition to providing strategic input to product publication teams and scientific congress planning teams, Scientific Affairs writers liaise with medical leads, biostatisticians, safety experts, and health economists as well as external opinion leaders, clinical investigators, and journal editors. Additional responsibilities may include the following: •Preparing or editing documents for submission to external regulatory agencies •Preparing or editing internal documents requiring robust scientific summaries •Writing, rewriting, performing QC checks, or editing materials for product dossiers •Conducting literature searches, reviewing pertinent literature, and preparing summaries or abstracts, as required •Attending scientific congresses and writing daily and post-meeting summaries Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications •Doctorate degree •Previous medical writing experience in a biotech or pharmaceutical company, or previous postdoctoral research in bone biology or osteoporosis •Experience analyzing and communicating scientific data in peer-reviewed journal publications and in abstracts and presentations at scientific congresses •Proficient in pertinent software (eg, MS Office, EndNote, Adobe Illustrator) •Knowledge of publication guidelines and best practices •Superb written and verbal communication skills •Experience working independently under limited supervision •Ability to apply project management skills to advance numerous projects simultaneously •Ability to work in a matrixed team environment2012-04-16 20:53:28United StatesAmgenCalifornia15338BRCAThousand Oaks, CA27929884http://www.amgen.jobs/xml/27929884/jobCZEField BasedAuto req 15357BR Job Posting Title Sr Biopharmaceutical Rep Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) Czech Republic Location (City) Field Based Amgen Job Description Maximizes sales of Amgen’s products in territory Achieves sales targets Delivers key messages Collaborates with manager to implement agreed POA in line with marketing strategy Identifies and establishes high quality customer relationships and internal collaboration Knows in-depth knowledge of the product(s), market , stakeholders and competitors Works within agreed budgets Collaborates with manager to develop and implement territory POA and key account plans . Achieve POA Evaluates progress vs. plan monthly and agrees to course corrections with manager Contributes to Cluster/Territory Teams Collaborates (Medical Affairs/Key Account Manager, etc.) to agree on key account plan objectives/responsibilities Engages with peers and District Manager to learn best practices Demonstrates an understanding of industry and healthcare trends, of how retail practices, clinics and hospitals operate. Identify and gather competitive information Follows through on customer commitments and requests in a timely fashion Reports customer activity in the CRM system and ensures customer profiles are kept up-to-date Demonstrates an understanding of Amgen Performance 4 selling platform to satisfy customer and Amgen needs Operates within the agreed expense budget aligned with POA priorities Seeks advise and assistance to organize activities Continuously develops and improves product knowledge, communication and selling skills through self-learning and active participation in agreed training programs. Drives own development Basic Qualifications Minimum 3 to 5 years of experience in the pharmaceutical industry in a sales-related job Basic knowledge of and experience in a hospital environment (not for specialist Sales Reps) Some experience with computer systems (CRM databases and MS Office) Fluency in local language, both in oral and written communication Relevant local legal qualification2012-04-16 20:53:14Czech RepublicAmgenNone15357BRNoneField Based, CZE27929881http://www.amgen.jobs/xml/27929881/jobUSAThousand OaksAuto req 15092BR Job Posting Title Project Manager - Device Delivery Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Project Manager will report into the Program Management Office within the Drug Delivery Organization. This role will lead cross-functional teams from multiple Amgen sites, and external partners, to develop innovative drug delivery devices that are integrated with biologics to create combination drug/device products. Position Responsibilities • Perform project management at a high level of professionalism. • Lead projects that utilize internal and external personnel, contract firms, and partners utilizing structured, systematic methodologies to meet objectives. • Follow Amgen’s governance processes, procedures, specifications, design controls, and applicable compliance standards and guidance documents. • Provide advanced knowledge of schedule management techniques and use of Microsoft Project to create and maintain detailed integrated schedule. • Negotiate and resolve personnel or project conflicts and drive consensus among team members to accomplish project and business goals. • Provide leadership to core team members and provide meaningful feedback to functional leaders regarding team member’s performance and ability to perform assigned tasks. • Foster continuous improvement in the organization’s ability to execute programs and projects, from initiation through launch • Manage program resources to meet business objectives. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications •Degree in engineering or related life sciences. • 4+ years as a project manager leading cross-functional program teams. • Successful track record of developing commercially viable medical devices/pharmaceutical products from concept through to commercialization. • Deep understanding of and experience with disciplined product development processes (phase/gate product development method). •Experience developing products that are manufactured at high volumes using automated and semi-automated manufacturing processes. • Successful experience working with contract development firms and contract manufacturers. • Strong oral and written communications skills; strong interpersonal skills; demonstrated time management and decision making skills required. • Advanced proficiency with Microsoft Project; experienced in creating complex schedules with logical relationships between successor and predecessor tasks. • Experienced in performing critical path analysis. • History as a project manager on FDA-approved 510(k) or PMA-approved medical device that was successfully commercialized. • Experienced with planning and composing documents for FDA submissions. • Experienced in creating and maintaining a Design History File. • Experienced within a CE-marked manufacturer. • Proven ability to manage in a highly fluid, matrix environment. • Experienced with managing programs with annual budgets exceeding $5M. • The ideal candidate will have experience from the medical device industry that includes developing patient use devices. • Certification in Project Management highly desired.2012-04-14 06:56:35United StatesAmgenCalifornia15092BRCAThousand Oaks, CA27897908http://www.amgen.jobs/xml/27897908/jobUSAThousand OaksAuto req 15164BR Job Posting Title Sr Associate IS Programmer Analyst (Technical Lead / Lead Programmer) Career Category Information Systems Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description As part of IS Enterprise Application Services organization, the Sr Associate IS Programmer Analyst will lead the design and oversee development of cross-functional, multi-platform application systems. Provide technical and process leadership while partnering with client-facing IS team to drive the tactical delivery of application solutions. Integrate systems across Amgen landscape and services. Lead technical aspects of application evaluations. Sets guidelines based on existing SOPs and standards as to the proper use of application development and integration patterns. Partner with architects, business analysts, system administrators, information security, project managers and other parts of internal solutions delivery and support teams as well as business partners to implement complex solutions. Ensure that the company's computing systems are capable of delivering both the basic functionality as well as all non-functional requirements (e.g. performance, scalability, fault tolerance, disaster recovery). Provide focused consulting services on projects and govern compliance of those projects with architecture standards and roadmaps while ensuring that the design and development teams remain compliant with evolving enterprise standards. Responsibilities: • Evaluate Product/COTS/Technology in partnership with Solution Architecture • Lead the Integration and Implementation of new Software Solutions that spans various Amgen systems and infrastructure • Plan phase/iteration goal and activities with project manager and technical team • Identify risks and mitigations with project manager and technical team • Understand scope and high level requirements and lead the solution elaboration and implementation • Guide project team on elaborating significant architecture risks • Participate in requirements solicitation to better understand system requirements • Own System Design Specification (SDS)/System Detailed Design Specification (SDDS), with input and support from an architect and technical team, coordinating SDS/SDDS review and approval • Identify technical resource/skills needed (Infrastructure, BizTalk, Informatica, Java, .NET, SQL, etc) and work with project manager on resourcing • Recruit, onboard, assign required SOP/training to contract developers • Identify administration/support skills needed (e.g. Server administrator, DB administrator, SSO administrator, Network/Firewall/VPN administrator) and work with project manager on resourcing • Coordinate development tasks (design, unit test, code, source control) and issue resolution among developers • Coordinate implementation activities and issue resolution for system deployment • Own Installation Qualification (IQ) process and documentation, with input and support from technical team, coordinating IQ review, approval and execution • Coordinate technical knowledge transfer with application support for post-go-live support • Occasionally involve in custom/interface development work on projects that require deep technical knowledge and skills (e.g. performance monitoring, early stage prototyping) Basic Qualifications - Master’s degree OR - Bachelor’s degree & 2 years of directly related experience OR - Associate’s degree & 6 years of directly related experience OR - High school diploma / GED & 8 years of directly related experience Preferred Qualifications Bachelor’s degree in Engineering, Information Systems or Computer Science 5+ year’s information technologies industry Experience with RUP or Agile software development methodologies Strong communication and presentation skills Experience leading a team of developers Experience with Microsoft Project or similar project management tools Experience working in a FDA regulated industry such as a pharmaceutical or biotech company Unified Modeling Language (UML) design skills Object-oriented programming (J2EE, Asp.NET, C#) skills Web user interface and Web Services application development skills Relational Database or SQL development skills2012-04-14 06:56:18United StatesAmgenCalifornia15164BRCAThousand Oaks, CA27897902http://www.amgen.jobs/xml/27897902/jobIRLField BasedAuto req 14626BR Job Posting Title Regional Medical Liaison Career Category Sales Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Field Based Amgen Job Description This position is a Regional Medical Liaison (RML) field-based position for the Bone Therapeutic Area in Ireland covering Maternity Leave for a 9-month period. The RML will interact with key opinion leaders/healthcare professionals to communicate and advance the scientific platform, as aligned with Amgen's corporate goals, objectives and affiliate medical plans and provide feedback based on those field interactions. The RML will foster relationships with key healthcare professionals including key registrars and nurses. The RML is an integral position in assuring accuracy in communication of our science and products across the medical community. The RML will communicate complex cutting edge, scientific information and research concepts to healthcare professionals and support Amgen sponsored research. The RML will represent Amgen medical department in the fiels within the Bone Therapeuticc Area in compliance with local and Amgen regulatory standards. Basic Qualifications Medical or scientific education with a minimum 3 years experience in similar positions or related jobs such as Medical Communications, Nurse Advisor, CRA or Medical Liaison. Preferred Qualifications Advanced degree (e.g. PhD, MD) preferred or strong demonstration of equivalent combination of relevant educational and professional training. Experience: - Working in the bone field - Setting up and running research studies in a hosspital environment - Knowledge of regulatory affairs, drug safety, legal and compliance environment (IPHA OR ABPI) - Network of customer contacts in bone field - PhD in a bioscience discipline2012-04-13 02:24:03IrelandAmgenNone14626BRNoneField Based, IRL27868810http://www.amgen.jobs/xml/27868810/jobFRANeuilly-sur-SeineAuto req 15074BR Job Posting Title Counsel - Responsable Affaires Juridiques Career Category Law/Legal Employee Subgroup Salaried FT Country (State/Region) France Location (City) Neuilly-sur-Seine Amgen Job Description Chez Amgen, notre vocation est d’être la meilleure entreprise pharmaceutique de biotechnologie, en utilisant la science et l’innovation afin d’améliorer significativement la vie des patients atteints de pathologies lourdes et invalidantes. Entreprise dynamique née dans les années 1980 aux Etats-Unis, Amgen a su se développer et s’implanter dans le monde entier. En moins de vingt ans, notre filiale française a vu croître parallèlement son chiffre d’affaires et ses effectifs. Aujourd’hui, ses 350 collaborateurs sont fiers de son statut de première filiale Européenne et de l’image dont elle bénéficie dans le monde de l’industrie pharmaceutique. Chez Amgen, vous travaillerez avec des collaborateurs performants et des leaders exemplaires, dans une culture imprégnée par nos valeurs. Notre entreprise a de belles réussites à son actif, une réelle volonté de développement et un avenir prometteur. Vous travaillez sous la responsabilité de la Direction Juridique Internationale du groupe Amgen. Vous représentez le service Juridique pour la France et assurez les fonctions suivantes: - Support Commercial et Marketing : o Recommandations juridiques sur les questions des clients (loi LME, droit de la concurrence, global pricing strategy..) o Préparation/négociation des contrats (grossistes, clients, centrales) o Support juridique en cas de litige/contentieux (en partenariat avec les départements marketing, commercial et réglementaire) - Support « Compliance » : o Conseil ponctuel auprès du manager Compliance (relations avec les professionnels de santé) o Conseil ponctuel auprès du département réglementaire sur le matériel promotionne le cas échéant o Participation au Comité de revue des dons o Participation au Comité de revue des contrats de partenariats - Protection des données : o Point de contact pour toutes les communications avec la CNIL et toutes les questions relatives à la protection des données pour la France o Préparation et soumission des dossiers à la CNIL - Support Développement (essai clinique, études observationnelles) /Réglementaire : o Revue des accords d’études cliniques et autres accords annexes o Revue des formulaires de consentement patient o Recommandations juridiques - Administration : o Point de contact dans la gestion des relations avec nos cabinets juridiques (notamment suivi budget et approbation des factures) o Communication régulière avec la Direction juridique de Zug Basic Qualifications Vous avez un 3ème cycle en droit médical, pharmaceutique ou des industries de santé et de solides connaissances en droit commercial. Vous justifiez d’un minimum de 5 ans d’expérience, dont une partie dans le secteur pharmaceutique ou des biotechnologies. Votre autonomie, votre esprit d’analyse et votre capacité d'adaptation et de communication sont les atouts majeurs pour ce poste. Vous faites preuve d’une grande réactivité et d’un excellent esprit d’équipe. Vous avez une très bonne maîtrise de l’anglais, à l’oral comme à l’écrit. Preferred Qualifications Si vous êtes en situation de handicap, n’hésitez pas à informer votre interlocuteur des Ressources Humaines de toute adaptation ou outil nécessaire au bon déroulement de l’entretien.2012-04-13 02:23:41FranceAmgenNone15074BRNoneNeuilly-sur-Seine, FRA27868804http://www.amgen.jobs/xml/27868804/jobFRANeuilly-sur-SeineAuto req 15304BR Job Posting Title CHEF DE PRODUIT ONCOLOGIE Career Category Medical Affairs Employee Subgroup Salaried FT Country (State/Region) France Location (City) Neuilly-sur-Seine Amgen Job Description CDD – Remplacement conge maternité Poste basé à Neuilly Missions : Basé à notre siège à Neuilly sur Seine, au sein de la Business Unit Onco-Hématologie et sous la responsabilité de la Responsable Marketing Oncologie, vous êtes en charge du lancement d’un nouvel anticorps monoclonal en Oncologie. En collaboration avec la Responsable Marketing Oncologie, vous assurez la mise en œuvre & le suivi du plan marketing de cette molécule ainsi que des opérations de lancement. Vous coordonnez la validation réglementaire et médicale des outils marketing que vous développez. Vous présentez les outils marketing et motivez les forces de vente à chaque nouvelle campagne. Vous avez un vrai rôle de leader et d’interface entre tous les départements de l’entreprise impliqués sur le produit. Votre veille active des évolutions de notre marché et de la concurrence vous permettra de proposer des opérations marketing spécifiques adaptées. Vous assurez le suivi budgétaire des actions que vous engagez. Vous êtes en contact avec un réseau de leaders sur lequel vous vous appuyez pour assurer l'efficacité de vos actions. Dans le cadre de votre fonction, vous êtes amené à participer à certains congrès nationaux et internationaux ainsi qu'aux réunions des forces de vente. Vous encadrez un stagiaire. Basic Qualifications De formation supérieure (scientifique ou commerciale) idéalement complétée par une spécialisation en marketing, vous justifiez d'une expérience de 2 ans en Marketing / Vente. Vous êtes force de proposition dans le cadre de votre fonction. Grace à votre leadership, vous avez prouvé vos qualités de chef de projets et vous êtes reconnu pour votre capacité à travailler en transversal avec des équipes pluridisciplinaires. Vos qualités relationnelles et votre bonne communication sont importantes pour établir une relation de confiance avec vos différents interlocuteurs internes et externes. Créatif, structuré et rigoureux, vous avez un esprit d’analyse et de synthèse. Preferred Qualifications Si vous êtes en situation de handicap, n’hésitez pas à informer votre interlocuteur des Ressources Humaines de toute adaptation ou outil nécessaire au bon déroulement de l’entretien.2012-04-13 02:23:40FranceAmgenNone15304BRNoneNeuilly-sur-Seine, FRA27868803http://www.amgen.jobs/xml/27868803/jobUSAThousand OaksAuto req 15168BR Job Posting Title Sr Associate Paralegal Career Category Law/Legal Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This employment law/litigation paralegal role will be responsible for all aspects of support of employment litigation, including complex litigation matters and responses to third-party subpoenas under the supervision of an attorney. Paralegal duties can include assisting in all aspects of discovery, including document retention, collection, management and control, witness/custodian interviews, and updating the managing attorney on case status, trial preparation, trial support and case management, interaction and coordination with the business, in-house attorneys, and outside counsel and tracking information. The candidate will work in a variety of litigation management software systems. The candidate will also assist in the extraction and/or analysis of data from various database systems and various company sources. The paralegal will be responsible for preparing drafts of contracts and modifying contract templates as appropriate, under the direction of an attorney. Basic Qualifications Master’s degree, or Bachelor’s degree & 2 years of directly related experience, or Associate’s degree & 6 years of directly related experience, or High school diploma / GED & 8 years of directly related experience Preferred Qualifications - 7+ years paralegal experience, preferably at a mid-sized to large-sized law firm or corporate law department - Formal paralegal training and certification - Basic computer skills (Word, Excel, PowerPoint) - Knowledge regarding document software systems - Ability to perform legal research and in-depth knowledge of legal terminology and principles - Ability to exercise independent judgment within broad parameters as determined by the attorneys managing the cases. - Strong communication skills – written, oral - Excellent interpersonal communication skills, including diplomacy and flexibility, and the ability to interface effectively with personnel at many different levels throughout Amgen - Ability to effectively interview custodians and document what is learned - Ability to prioritize, meet deadlines, and function within a cross-functional and fast-paced environment - Excellent organizational and multi-tasking skills - Demonstrated ability to manage project work and problem solve - Demonstrated ability to work both as a team player and independently - Ability to maintain integrity of confidential and sensitive information - Enthusiastic, positive can do” attitude and self-starter” qualities enabling him or her to manage responsibilities with an appropriate sense of urgency - Experience with document preservation and collection issues - Experience with the issuance of and compliance with hold orders - Experience with e-discovery, including experience collecting, storing, transferring, searching, and producing electronically stored data - Experience in preparing contracts - Proficiency in a variety of litigation management software systems - Ability to assist in the extraction and/or analysis of data from various database systems and various company sources.2012-04-13 02:23:19United StatesAmgenCalifornia15168BRCAThousand Oaks, CA27868802http://www.amgen.jobs/xml/27868802/jobUSAThousand OaksAuto req 15105BR Job Posting Title Finance Mgr Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Since 2007, Amgen’s corporate strategy has quickly integrated a more pronounced role for external alliances (e.g., in & out licenses, co-development partnerships, co-promotion sales & marketing), to help identify and develop new medicines and/or commercialize late stage opportunities. This role will provide financial oversight, analyses and management reporting of external alliances by working closely with internal and external stakeholders to forecast partnership revenues and expenses. Job functions include: •Primary Amgen financial interface for external alliance requests and activities •Work closely with Amgen staff and external representatives to prepare detailed financial modeling and analysis to support strategic planning, negotiations and operational decision making. This includes working with Functional FP&A, Accounting, Corporate Development, Alliance Management, Legal, Tax, Treasury and Operations/R&D personnel. •Understand the business drivers of each partner’s activities, the full partnership P&L and its impact on Amgen’s financial statements •Provide quantitative input on valuation issues related to partnerships •Work with Partnership Accounting to manage quarterly billing process between partners, resolve discrepancies and work with appropriate staff to ensure processes are in place to handle changes in the business •Review and become a content expert for external alliance agreements. Provide guidance when questions arise as to why and how costs are accounted for, billed and forecasted. Ensure billable time and recoverable costs are captured and forecasted correctly. •Ensure milestones associated with partnerships are planned for and managed appropriately through an existing database tool •Manage royalty expense and income forecasts via input from Legal and Accounting •Provide support as required for partner meetings. Travel may be required to meet with partner staff and ensure good working relationships. •Be proactive in proposing new processes, strategies, etc. for partnership management Basic Qualifications ?Master’s degree & 3 years of directly related experience OR •Bachelor’s degree & 5 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience Preferred Qualifications -MBA and/or CPA -5+ years experience in Financial Planning & Analysis and/or Accounting -Prior work experience in, and understanding of, pharmaceutical business -Demonstrated leadership capability and team leader/player skills -Strong analytic, organization, problem-solving and communication skills -Working knowledge of Cognos PowerPlay, TM1, GPS and SAP applications. -Excellent Excel and PowerPoint skills2012-04-13 02:22:44United StatesAmgenCalifornia15105BRCAThousand Oaks, CA27868797http://www.amgen.jobs/xml/27868797/jobUSAThousand OaksAuto req 15102BR Job Posting Title Regulatory Affairs Director (Asia/China) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The purpose of this role is to facilitate registration of Amgen products in Asia, with a focus on China, through executing our international expansion plans; providing strategic regulatory expertise; interfacing with agencies on regulation; aligning with key Amgen cross-functional partners; integrating into Amgen’s commercialization process, and continuously improving our processes and developing our talent. Specifically: - Regulatory expert providing support to commercialize Amgen products in one or more priority programs in a Therapeutic Area Team(s) - Provide regulatory support to advance the pipeline in Asia with a focus on China - Primary regulatory liaison between the GRT, PSTs, the country offices. Will provide regulatory guidance to GRT, PSTs and support various Amgen teams involved in drug development and commercialization in Asia with a focus on China - The country GRAAS office may report into this position Responsibilities: - Provide leadership and manage various regulatory teams based in countries or regional hubs in the development and execution of regulatory strategies at the country/regional level by maintaining current knowledge of the regulatory requirements - Participate in the development of regulatory strategies by leading various Amgen teams on the regional regulatory requirements for submissions. Support the development and implementations of regional registration and compliance strategies of new and current products - Lead PST members and other teams for regulatory activities to ensure effective interactions with regulatory agencies in the region - Organize and manage various meetings for regional regulatory deliverables including Clinical Trial application (CTA), Marketing Application (MA) submissions and agency interactions - Oversee internal stakeholders and external vendor/contractor relationships - Review routine regulatory correspondence - Ensure QC of regulatory documentation - Ensure collection of functional documents in support of regulatory applications - Ensure development and maintenance of CTA/MA documentation in collaboration with Amgen product teams and the GRAAS regional hubs - Contribute to creation and maintenance of product regulatory history documents through IMR and appropriate archiving of all regulatory documents and agency communications. - Ensure regulatory obligations in relation t the product are properly handled - Works actively cross functionally within the various Amgen teams to coordinate activities related to CTA and MAAs - Evaluation of preferred vendors (CTOs, consultants, contractors - Provide strategic and timely regional regulatory input to RT, GDT, GOT and other cross-functional project meetings - Conduct contingency regulatory planning/risk assessment for regional development strategies and agency interactions - Evaluate and communicate impact of relevant regional regulations, guidance and current regulatory environment - Participate actively in various industry working groups to anticipate / evaluate the impact of new regulations and/or changes to the valid and current regulations - Provide leadership and expertise and guidance on teams for interdepartmental and cross-functional teams including, process improvement standards development, and metrics - Develop and deliver training materials on regulatory affairs for intra- and inter-functional purposes - Act within Amgen financial policies and request appropriate funds for filings - Coordinate preparation of controlled documents to ensure regulatory affairs operate in compliance with all regulatory duties and work in compliance with all relevant controlled documents Basic Qualifications - Doctorate degree and 4 years of directly related experience OR - Master’s degree and 8 years of directly related experience OR - Bachelor’s degree and 10 years of directly related experience Preferred Qualifications - Mandarin language - Good understanding of Chinese regulatory landscape Knowledge and Skills: - Demonstrated knowledge of Asian regulations, policies, procedures, drug development guidelines and compliance - Strong communications skills – oral and written - Highly developed regulatory project management skills - Ability to work with high degree of autonomy - Ability to influence and motivate others outside of direct line of authority - Relies on extensive experience and judgment to plan and accomplish goals and objectives - Ability to understand and communicate scientific/clinical information - Demonstrable ability to manage several complex projects in parallel - Relies on extensive experience and judgment to plan and accomplish goals and objectives - Ability to influence and motivate others outside of direct line of authority2012-04-13 02:21:48United StatesAmgenCalifornia15102BRCAThousand Oaks, CA27868772http://www.amgen.jobs/xml/27868772/jobUSAThousand OaksAuto req 15156BR Job Posting Title Sr Mgr Disbursements Shared Svcs Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Manage and direct day-to-day activities for one or more global sub areas within the disbursement organization (Payroll, Accounts Payable, Staff Expense Management, Operations). The Sr. Manager is responsible for ensuring approximately $6 billion in annual disbursement spend is processed correctly and on time. This position will partner with internal departments/customers to ensure that we are driving towards best-in-class processes and organization. The individual will be a key driver of improvements from both a process and organizational perspective. Additionally, this individual will provide oversight and strategic direction for the applicable sub areas within disbursements. In addition to the day-to-day operations, this individual may lead and/or participate in improvement projects and must have the ability to effectively manage change. Project related responsibilities include budget, scheduling and delivering results. This individual will also work closely with key clients, and vendors to resolve issues and drive end-to-end process improvements. This individual will also be responsible for ensuring that our processes are compliant and for overseeing the quarterly SOX certification process for disbursements. Finally, this individual must have proven ability to build and nurture strong working relationships with all levels of the organization. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree or & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications •BS Degree in Finance / Accounting/Management or closely related field •Experience with ERP systems (SAP) •Proven management / leadership skills/and advanced analytical skills in a large organization •Minimum of 7 years Accounts Payable, Payroll, Disbursement Accounting or other large scale transactional processing or equivalent experience at (at least 5 years in a management/leadership position ) •Advanced analytical skills – Advanced excel, Access etc •Excellent written and verbal communication skills •Proven team builder/team participant •Ability to quickly understand and solve operational challenges/problems •Project Management experience •Experience with managing virtual teams (outsourced service providers) •MBA,/ CPP / CPA / CMA etc. or other professional certification desired •Internal/External Audit experience •Consulting •Accounting / Procurement experience •Experience with managing global processes •Knowledge of regulatory requirements related to the disbursements area2012-04-11 22:08:42United StatesAmgenCalifornia15156BRCAThousand Oaks, CA27821428http://www.amgen.jobs/xml/27821428/jobUSAThousand OaksAuto req 15173BR Job Posting Title Sales Operations Senior Manager, Reporting & Analytics Career Category Sales & Marketing Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Sales Operations Senior Manager will be responsible for commercial reporting and analytics in support of the Oncology sales force. This involves regular periodic reporting deliverables, ad hoc requests for reports and analytics, and proactive analysis in pursuit of insights that increase the effectiveness of the sales force and drive sales growth. This position will have significant interaction with sales leadership including the national sales director, BAI, Commercial Information Management, IS, and Marketing. Responsibilities of this role include the following: • Proactively recommend innovative improvements to reports, models, systems and standardized templates to ensure usability and value for the sales force; frequently seek feedback and suggestions from customers to further define and enhance reporting systems and processes • Research, analyze and resolve problems related to reporting and analytics raised by sales management and sales reps • Work with Sales Operations Manager (direct report) to ensure that reports are timely, accurate, and provide actionable information • Develop QC standards and processes and perform hands on QC as required. • Work closely with Incentive Compensation and POA/Activity teams to ensure that reporting deliverables properly reflect changes in those areas • Provide critical thinking in partnership with Sales, BAI, and others in Sales Ops and continuously develop further understanding of the Oncology business and complex product portfolio. • Perform complex modeling based on brand strategy, POA, and sales strategy used for fact based decision making. • Coach and partner with Sales Operations Manager • Provide training materials to the field and present to new hires as required • Ensure adherence to compliance/legal regulations for reporting and analytic work • Direct and manage contract resources to ensure that resources are aligned with business priorities and are delivering according to plan. • Work closely and collaboratively with the Director of Sales Operations on all analytic matters related to the sales force. • Provide prioritization and participate in rationalization efforts across business units for common platforms such as RADAR. • Communicate to appropriate audiences in the sales force regarding enhancements, future deliverables, disruptions in reporting delivery or quality. • Play a key role on Sales Ops Advisory Panel Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Master’s degree in business, statistics, information management, life sciences • 7+ years of experience solving business problems and analyzing data. • 5+ years of experience working in Sales Operations or Business Analytics/Intelligence within the pharmaceutical or biotech industry. • Experience with sales and activity reporting, incentive compensation, POA, and internal Amgen systems such as CMA and RDS is a plus. In addition, deep knowledge of Pharmaceutical data including IMS DDD, Xponent data, and charge back data is highly desirable. • Strong analytical skills and attention to detail with the capability to appropriately define issues, questions, and data; to comprehend qualitative and quantitative methods to perform accurate analysis. • Proven experience, knowledge, and skills related to defining and optimizing reporting and analytical needs, deploying action plans, and determining future capabilities • Ability to consolidate and present key findings to relevant parties, explain complex concepts clearly to a variety of audiences, and demonstrate willingness to present the facts and put forth hypothesis in the face of differing opinions. • Strong client service orientation, user support, and vendor management skills • Must have strong facilitation skills to negotiate effectively in challenging situation and demonstrate creativity and innovation. • Ability to adjust to changing needs within the organization and to change priorities as needed • Demonstrated ability to translate business requirements into progressive solutions and prioritize work • Possess qualities such as strong organization skills, attention to detail, passion for meeting/exceeding client expectations, and intellectual curiosity to research pertinent information that further informs/educates the commercial team • Excellent skills in complex analytic problem solving, planning, project management, and change management • Substantial knowledge in one or more of the following: quantitative analysis, financial analysis, information systems, organization development, decision science, operations research, statistics, or project management. • Excellent communication skills – written, oral, and presentation -- appropriately gauged to a broad range of audiences from senior leadership to front-line field staff and to peers in various disciplines. • Demonstrated experience leading projects and/or personnel, with proven success influencing clients, customers, and team members • Expertise in Microsoft products Excel, Access, and PowerPoint.2012-04-11 22:08:41United StatesAmgenCalifornia15173BRCAThousand Oaks, CA27821425http://www.amgen.jobs/xml/27821425/jobUSAThousand OaksAuto req 14592BR Job Posting Title Sr Associate Training & Development - Information Systems Career Category Information Systems Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position -- based at Amgen's corporate headquarters in Thousand Oaks, CA -- will be part of the Information Systems (IS) Learning and Performance Team within the Compliance Organization of Enterprise IS Technical Services and will be responsible for sustainment of multiple training programs, leading continual improvement projects and providing Capital/Expense funded training lead support. The successful candidate will work with IS management, training development vendors, Learning Management System support teams and other training stakeholders and services to drive value-added, effective training programs with industry best practices. Some travel may be required based on specific project assignments. Key Responsibilities • Responsible for supporting training programs based on existing standards to meet client and organizational objectives. • Manages multiple training projects, vendor commitments and internal SME deliverables in support of IS systems, services and compliance requirements. • Interfaces and provides consultative training support for IS Managers in assigned areas. • Provides guidance to IS Staff and Management on use of tools and resources to support internal team knowledge and skill development • Monitors assigned area for training compliance and provides preventative maintenance support. • Maintains course assignment requirements • Oversees training releases and deployments for areas as assigned • Provides Demand Management of inbound training requests and training documentation changes that impact staff. • Interfaces with internal clients to assess and develop effective and quality training deliverables. • Reinforces adherence to training standards. • Maintains and drives continual improvement cycles on training programs for Enterprise-wide systems • Responsible for effective delivery of training as requested. Includes virtual delivery, in-person classroom training and recording. • May participate on global training teams as assigned. • Facilitates the assignment and un-assignment of training courses/modules for staff members. • Provides internal process and knowledge documentation and ensures alignment with IS and Corporate document strategy • Provides quality control over training documentation and maintains training library • Develops and maintains templates for developing training content and assists SMEs, system owners and IS professionals in leveraging templates. Basic Qualifications Master’s degree OR Bachelor’s degree & 2 years of directly related experience OR Associate’s degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience Preferred Qualifications • Good project management skills • Strong customer service orientation and influencing skills to work directly with client staff and identifying performance needs. • Solid working knowledge on computer software programs including: Word, Excel, PowerPoint, Outlook, and SharePoint. • Ability to deliver training • Experience supporting SAP environment through training or service support • Demonstrates understanding of Amgen’s business and culture, and ability to work effectively with staff at all levels • Technical competency commensurate with assigned area(s) of responsibility • Good interpersonal and presentation skills • Able to accomplish results through own work and through influencing client staff members and management • Able to work in a matrix team environment2012-04-11 22:08:25United StatesAmgenCalifornia14592BRCAThousand Oaks, CA27821421http://www.amgen.jobs/xml/27821421/jobUSASeattleAuto req 14400BR Job Posting Title Sr Project Manager - Cardiovascular Therapeutics Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - California United States - Washington Location (City) Seattle Thousand Oaks Amgen Job Description The Sr. Project Manager provides project management support & leadership to Research Programs / Research teams, and his/her functional line Supervisor. The Sr. Project Manager must apply project management best practices in the development, initiation, planning, execution, control & closing of projects. Key Responsibilities Team Leadership- Provide operational leadership in team meetings and identify, risks and issues. Elevate team issues and work to overcome implementation obstacles. Ensure strategic alignment between Research project teams of different modalities as appropriate. Drive effective team operations, including goal setting, team charters, mgmt reviews, etc. Communication-Maintain communication with Research leaders to ensure despite sifting priorities that support is given to those Research teams of highest priority. Provide timely, accurate communication between teams as appropriate. Communicate appropriate information on team status & issues to stakeholders. Strategic Thinking –Ensure support to the highest priority projects. Actively participate in research team discussions and ensure all views are heard. Assist teams and team leaders in the development of plans, appropriate updates to plans, and management of the process to ensure Governance Board review and approval of changes to plan. Risk Management- Conduct team-level risk assessment and scenario planning to support team issues. Proactively drive development of contingency and/or risk-mitigation plans. Project Management Process- Manage all aspects of projects/processes: planning, estimating, sequencing and scheduling, monitoring and controlling, risk management, execution, and closing. Maintain a master project plan and schedule for assigned projects. Translate team plans into actionable and measurable tasks. Follow up on action items from team meetings. Establish and achieve project standards for work quality and quantity. Product Team Deliverables- Ensure adherence to Commercialization and governance processes. Assist in the development/update of key Commercializationteam deliverables. Generate periodic updates and/or prepare formal presentations for management reporting. Provide detailed data support for portfolio management presentations. Drive the development of research plans, update plans appropriately, and manage the process to ensure Governance Board review and approval of changes to plan. This role can be in either Thousand Oaks, CA or Seattle, WA. Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - Project Management Professional(PMP) certification desired. - MS, MBA or PhD - 7 or more years of experience in cross-functional pharmaceutical development project teams and/or experience with project management practice within the pharmaceutical industry - Experience in early drug development (prior to preclinical –Phase1)2012-04-11 22:08:16United StatesAmgenCalifornia14400BRCASeattle, CA27821417http://www.amgen.jobs/xml/27821417/jobUSAThousand OaksAuto req 14554BR Job Posting Title Sr Packaging Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position reports into the Primary Container Engineering group under Drug Product Engineering in Thousand Oaks. This position will be required to apply advanced and diverse engineering principles to execute the proper design, qualification and implementation of Primary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position. This position is responsible and accountable for the following: 1) Evaluation, recommendation and selection of primary packaging materials for large and small molecule drug products. 2) Write test and execute protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials. 3) Write Technical Specifications and Bill of Materials 4) Representing Primary Container Engineering in Drug Product and Global Operation Teams 5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes 6) Ensures that required line trials and packaging validation is conducted prior to introduction of any new or change in components/processes 7) Ensures cGMP and regulatory compliance are met 8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes 9) Author primary container sections for all global market applications and support filing activities 10) Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed 11) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities. 12) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems. 13) Oversees project implementation of critical new package platforms. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications MS in Engineering or Life Sciences 5 to 7 of packaging engineering experience with 4+ years within the Pharma/Bio industry The position requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, the ability to work in multi-functional teams and adapt to rapidly changing environment.2012-04-11 22:06:59United StatesAmgenCalifornia14554BRCAThousand Oaks, CA27821397http://www.amgen.jobs/xml/27821397/jobUSAThousand OaksAuto req 15093BR Job Posting Title Director IS (Clinical Operations) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Director IS Clinical Operations will be responsible for the successful management and execution of the IS support activities related to the Process and Product Engineering (P&PE) organization. In this capacity the Director IS Clinical Operations will also provide direct oversight to the services provided in support of the Clinical Manufacturing processes at the Thousand Oaks site. This role will also ensure that other functions at the site, which directly support Clinical Manufacturing, receive IS support such as Pilot Plants and Site Non GMP Engineering. This individual will be responsible for carrying out the IS Project Portfolio the P&PE organization as well the other supporting functions. In addition this position will also oversee M&A Integration activities for any Clinical Sites Travel up to 20%. Responsibilities include: • Continuously drive improvement processes & governance for IS in support of P&PE organization • Drive and Maintain the IS strategy in support of the assigned Client Groups • Successfully lead and build the Clinical Operations IS Team • Create strong partnerships with other Operations IS Sites and linkage with the Corporate OIS team. • Manage multiple integrations Position Specific Tasks: Strategic Influence • Independently determines approach to managing daily operations for assigned areas guided by Amgen policies and management guidance • Interprets and executes policies that directly affect work activities • Develops and communicates plans/objectives to team • Contributes to functional strategy of the supported functions • Delivers results through professional employees and/or skilled technicians • Sets project timeframes and priorities based on project objectives and ongoing assignments • Develops and monitors Department budgets and goals • Provides guidance and technical advice and becomes actively involved as required Relationship focus • This position will have a solid line reporting relationship to the Executive Director of OIS and a dotted line reporting relationship to the Executive Director of Clinical Operations. • Develops relationships with all OIS staff and Site IS staff at various management levels to resolve issues and help staff complete specific phases of projects • Takes accountability of the day-to-day operations of the Clinical Operations IS team • Partners with Corporate OIS functions to ensure alignment on strategy and execution processes • Collaborates with various M&A teams and represents OIS on M&A activities to ensure the Operations function is best represented Leads Clinical Operations IS team • Provides people/performance management, coaching and mentoring of staff • Directs staff on project content/approach. • Builds, maintain, and retain successful team • Manages allocation of the team resources in support of the Client Areas • Elevates issues that may affect successful completion of projects in a timely manner • Focuses on Operational Excellence as a means of driving continuous improvement • Ensures the outmost state of compliance with Policies and SOPs at the ATO site from an IS perspective Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience AND • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Bachelor’s degree in Computer Science, engineering, life or physical sciences; • Advanced degree in Computer Science, engineering, life or physical sciences, or business (MBA) • 12+ years of biopharma experience with 15+ years experience in operations/manufacturing/clinical manufacturing/IS, to include cGMP regulated environments • 5 years of supervisory experience with demonstrated skills in staff motivation, coaching/mentoring and professional development. • Experience working cross-functionally and building collaborative working relationships; interfacing effectively with Operations and IS Senior and Executive Management to resolve issues • Excellent communication capabilities vertically and horizontally. • Ability to deal with complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and facilitate decision-making • Certified or experience in process improvement methodologies such as Lean/Six Sigma • Facilitation/ Planning / Negotiation / Coaching & Project Management skills • Results oriented, strong adherence to timelines • Excellent ability to translate knowledge and build high performing teams • Demonstrated working knowledge on automation systems & manufacturing information systems in cGMP regulated environments, FDA cGxP and 21 CFR Part 11 regulations, software development lifecycle and system validation. • Direct experience with Shop floor Automation systems (DCS, PLC/SCADA, BAS), MES systems, Manufacturing IT infrastructure, and Plant Systems & data integration, and Information Management required. Experience with Emerson DeltaV, Rockwell PLC/SCADA/Batch, OSIsoft PI data historian, Werum PAS/X, MES and BMS is preferred. Experience in other areas of Information Systems supporting manufacturing business unit is a plus. • Demonstrated working knowledge of enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering. • ERP experience is a plus.2012-04-09 21:20:27United StatesAmgenCalifornia15093BRCAThousand Oaks, CA27759051http://www.amgen.jobs/xml/27759051/jobUSAThousand OaksAuto req 15163BR Job Posting Title Exec Dir Process Development - Network Process Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Process and Product Engineering Group (P&PE) is working as an integrated function to deliver reliable clinical supply and enable and support robust commercial processes globally. We will dramatically reshape traditional process characterization, technology transfer, validation and commercial support of both drug substance and drug product through the use of clinical production data, the deployment of transformational remote monitoring and control capabilities, and a state of the art knowledge management system. The Executive Director of the newly created Network Process Engineering (NPE) (formerly Global Process Engineering or GPE) will have P&PE-wide responsibility to oversee the development and deployment of critical performance improving analytics and technologies. These will include Process and Systems Analytics, advanced process modeling technologies, P&PE Knowledge Management, CMC Excellence, and business performance capabilities for P&PE including OE, Business Analytics, and PMO. Responsibilities will also include P&PE Materials Science group. The Exec Director NPE will also be responsible for working as part of the P&PE Senior Team and with our stakeholders to refine and achieve our future state. Basic Qualifications • Doctorate degree & 6 years of directly related experience OR • Master’s degree & 10 years of directly related experience OR • Bachelor’s degree & 12 years of directly related experience AND • 8 years of managerial experience (directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in a matrixed environment) Preferred Qualifications • Experience within Amgen Operations of leading a Function or Plant, including supervision of senior staff, with demonstrated track record • 15+ years of experience in the biotechnology/pharmaceutical industry including engineering and/or advanced business performance improvement • Advanced degree in Science or Engineering • MBA or financial qualification in addition to Science/Engineering degree • Proficient with pharmaceutical product commercialization and life cycle management; ability to recognize strategic implications of complex product development activities • Expertise in business analyses and its application to applied sciences • Excellent communication abilities; ability to communicate vertically and horizontally through multiple channels, to motivate diverse teams, and enable cross-functional collaboration2012-04-09 21:20:02United StatesAmgenCalifornia15163BRCAThousand Oaks, CA27759044http://www.amgen.jobs/xml/27759044/jobUSAThousand OaksAuto req 15158BR Job Posting Title Scientist - Chemical Process Research and Development Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description A Scientist in the CPR&D Department (Chemical Process Research and Development) is responsible for development of the technology enabling manufacture of Amgen’s drug substance candidates from pre-clinical to commercial scales. The Scientist will participate in drug substance development teams and be expected to develop innovative solutions to prepare Amgen drug substances. KEY RESPONSIBILITIES*: SCIENTIFIC/TECHNICAL • Develop technology to deliver Amgen’s API candidates in a practical, efficient and safe manner. • Participate in drug substance teams and collaborate cross-functionally with analytical and drug product representatives to delivery drug substance manufacturing processes in a phase appropriate manner. • Work cross-functionally to deliver CMC regulatory documents and supporting documentation in support of Amgen’s small molecule regulatory filings. • Work with external partners to deliver key intermediate or drug substances in support of Amgen’s small molecule pipeline. • Deliver processes amenable to cGMP operation and carry out deliveries of drug substance in a cGMP manufacturing environment. TEAM EXPERIENCE • Demonstrates ability to effectively participate on drug substance development teams as a team member or primary department representative • Represents the department in various departmental and interdepartmental committees that address scientific and administrative initiatives • Participates in and can direct team efforts directed at advancing development/technology programs within the department • Applies team experiences to facilitate cohesiveness and build team spirit ORAL AND WRITTEN COMMUNICATION • Authors, or provides direction for the authorship of, technical reports or regulatory submissions which may require minimal additional editing. • Gives effective presentations within the department and to senior management with minimal supervision. • Actively creates, generates, and presents paper/presentations at scientific meetings. • Capable of organizing and conducting effective meetings. • Learns and applies facilitation and listening skills. SUPERVISING OTHERS [MAY HAVE DIRECT REPORT(S)] • Ensures that safe laboratory practices are followed. • Trains less-experienced staff. • Demonstrates ability to direct the activities of others. LEADERSHIP AND INFLUENCE • Identifies resources and develops timelines for project activities. • Learns to organize, plan, and control multiple project activities effectively to meet corporate timelines. • Effectively and actively participates on one or more project team with demonstrated ability to occupy a leadership role. Basic Qualifications • Master’s degree & 4 years of scientific experience OR • Bachelor’s degree & 6 years of scientific experience Preferred Qualifications • Ph.D. in Organic Chemistry and 0-5 years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams • A BS Scientist with a minimum of 10+ years pharmaceutical industry or MS scientist 8+ years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams. • Experience with the techniques associated with the synthesis, purification and characterization of organic molecules • Experience with protein expression in E. coli and intein or sortase technology • Experience with large molecule purification techniques • Experience with synthetic organic techniques applied to peptides • An scientific track record which may include peer reviewed publications, scientific conference participation • Experience with the use of analytical instruments (HPLC, NMR, IR and MS) and interpreting the scientific data based upon these techniques. • Demonstrated communication and scientific writing skills.2012-04-06 21:47:28United StatesAmgenCalifornia15158BRCAThousand Oaks, CA27706681http://www.amgen.jobs/xml/27706681/jobUSAThousand OaksAuto req 15113BR Job Posting Title Sr Systems Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Sr Systems Engineer (SE) leads small to mid-sized cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables of an NPI program. The SE drives the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality. The SE must understand and capture the user needs into system requirements and is responsible for the architectural decomposition and allocation to subsystems. The SE ensures that the quality targets are satisfied and retires technical risks as they arise on the program. The SE maintains close interaction with customers to understand and enhance the ability to deliver customer satisfaction through higher product quality. Ensuring that the quality targets are satisfied and retires technical risks as they arise on the program. Leading the design team and design control process from requirements development and design planning to design transfer. Leading the design team in the development of verification and validation planning and execution. Developing requirements flow down, architecture/system design and analysis, risk analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction. Create and maintain artifacts (models, diagrams, documents) by evaluating needs, clarifying requirements, and analyzing use cases and dependencies to functional specifications to support hardware and software development at system and component level. Driving the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality to evaluate and select optimum design alternatives. Accountability: • Analyze problems involving cross-disciplinary aspects of the product development process, synthesize multiple disciplinary solutions. Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problems. • Provide direction and support for the optimal design of complex, large scale systems through consideration of the system as a whole, rather than individual components of the system. • Provide various client areas with accurate and consistent requirements information to help them make critical technical decisions based on complete and unambiguous insight into cross-systems functionality. • Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones. • Conduct and review advanced computer simulations to design or test products. • Prepare cost estimates on proposed major design products. • Provide technical presentation support and consultation to marketing. • Represent company unit in customer or field force contacts. • Recommend the addition, expansion or termination of research projects and assure the technical soundness of engineering programs. • Produce innovative technical solutions to customers. • Prepare technical proposals for competitive bids. • Develop potential applications to exploit new business opportunities. • Collect and analyze information on competitor product performance. • Utilize project planning and monitoring methods to ensure timely completion. • Originate and communicate concepts which could lead to new products. • Review and approve completed design work. • Actively contributes to identifying and pursuing new technological opportunities Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications Masters Degree in Engineering and 5 years progressive experience as an engineer or scientist working with Medical Devices, ideally Class II and Class III • Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components. • Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product. • Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc). • Experience in model-based design and UML and Small scale device assembly experience. • Experience in system design and architecture that ensure product development success and ensuring Accurate Development Cycles between teams. • Leadership ability for System Level Design and Testing (Verification and Validation testing of System Level Performance) • Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis) • Experience in resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design tradeoffs, tolerance/performance analysis, etc. • Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position • Familiar with the following standards: US Good Manufacturing Practices – 21CFR820 Quality Management – ISO 13485 Risk Management – ISO 14971 EU Medical Device requirements – Council Directive 93/42/EEC Medical Electrical Equipment – EN 60601 • Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software. experience highly desired • Practical experience in configuration management and change control process/requirements – CCB (change control board), CIT (change implementation team) concepts • Experience working with cross department teams to analyze feasibility and ensure that all systems are being built in consideration with one another • Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives. Desired Characteristics • Demonstrated applied lean 6 Sigma competency • Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place and current. • Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues. • Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program. • Strong interpersonal skills • Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program • INCOSE certification or formal Systems Engineering training/certification2012-04-06 21:46:17United StatesAmgenCalifornia15113BRCAThousand Oaks, CA27706661http://www.amgen.jobs/xml/27706661/jobUSAField BasedAuto req 15110BR Job Posting Title Sr Biopharmaceutical Rep, Oncology - Dayton, OH Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Ohio Location (City) Field Based Amgen Job Description Territory: (#)15205 Dayton, OH - covering Dayton and Lima, OH As a Senior Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Basic Qualifications Bachelor’s degree & 2 years of directly related experience OR - Associate’s degree & 6 years of directly related experience OR - High school diploma / GED & 8 years of directly related experience Preferred Qualifications Two+ years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries - Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred - Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred - Local Market knowledge - A Bachelor's degree in Life Sciences or Business Administration Core Competencies: - Planning and Organizing Work - Engaging Others Through Effective Communication - Drive to Achieve - Individual Leadership and Impact2012-04-05 19:45:34United StatesAmgenOhio15110BROHField Based, OH27668156http://www.amgen.jobs/xml/27668156/jobUSAThousand OaksAuto req 15121BR Job Posting Title Sr Packaging Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position reports into the Device & Package Engineering (D&PE) group under Global Drug Product and Device Development in Thousand Oaks, CA. The position falls within 2 different categories in D&PE: Pre-Commercial and Commercial Engineering, supporting global supply, launch delivery, partnerships/acquisitions and devices. This position will apply advance and diverse engineering principles to execute the design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position. This role requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment. This position is responsible and accountable for the following: - Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product. - Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials. - Write Technical Specifications and Bill of Materials - Representing PD&E in Drug Product and Global Operation Teams - Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes - Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes - Ensures cGMP and regulatory compliance are met - Ensures that change control procedures are followed working with QA and Regulatory to implement changes - Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed - Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities. - Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems. - Oversees project implementation of critical new package platforms. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications - MS in Packaging, Engineering or Life Sciences - 7 or more years of packaging/engineering experience with 4+ years within the Pharma/Bio industry Demonstrated Competencies/Skills: - Independent thinker with demonstrated skills working in teams or leading project teams - Strong Interpersonal and communication skills2012-04-05 19:45:29United StatesAmgenCalifornia15121BRCAThousand Oaks, CA27668150http://www.amgen.jobs/xml/27668150/jobUSABothellAuto req 13445BR Job Posting Title Product Quality Director Career Category Quality Employee Subgroup Salaried FT Country (State/Region) United States - California United States - Colorado United States - Puerto Rico United States - Rhode Island United States - Washington Location (City) Bothell Boulder Field Based Juncos Lake Centre Longmont Seattle Thousand Oaks West Greenwich Amgen Job Description The successful candidate will become a Product Quality Leader (PQL). The individual will provide technical expertise and project leadership to the relevant Product Quality Team(s) to develop, implement, and manage strategy for Quality to meet the Global Operations Teams (GOT) and product goals for Amgen products. As a product expert in Quality, the Product Quality Leader has responsibility for working directly with other PQLs, Global Operations Leader (GOLs), International Expansion (IE), Corporate Quality Control (QC), site QC, Regulatory, Process Development (PD), Quality Assurance (QA) etc. on the resolution of issues associated with process/manufacturing, In-Process Control (IPC), analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions, international expansion and inspections related to Amgen product(s). The individual will be directly responsible for Product Quality related tasks in support of Amgen’s late-stage clinical and commercial products. These tasks include but are not limited to; ownership, authoring and review of documents, and execution of transactions in relevant GMP systems (change control, etc.). In addition to these responsibilities, the candidate will be expected to play a role in supporting other product quality issues and initiatives intended to ensure the overall product health. This position can reside at Amgen sites in Thousand Oaks, CA, CO, RI or Puerto Rico. Basic Qualifications ? Doctorate degree & 4 years of directly related experience OR ? Master’s degree & 8 years of directly related experience OR ? Bachelor’s degree & 10 years of directly related experience Preferred Qualifications B.S. in biochemistry, biology, or a related protein/biotechnology sciences field 10 + years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment, OR - an Advanced degree in biochemistry, biology, or a related protein/biotechnology sciences field and 7 + years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience. - 10+ years working in a regulated environment (either direct GMP or technical support) - 4 + years experience with authoring or review of biological license applications, IND, supplements or similar regulatory documentation. - 4 + years experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances - Experience in Project Management in support of biopharmaceutical development There is a strong preference for candidates who are familiar with compliance and regulatory requirements of the FDA as well as international regulatory agencies in international expansion regions. Prior experience in direct interaction with regulatory agencies during inspections or meetings is helpful. Knowledge of analytical techniques used for biologics product quality control. Understanding of biopharmaceutical bulk and drug product development and manufacturing. Familiarity with Bispecific T cell Engager (BiTE) antibody technology. In-depth knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals. Previous experience working on a cross-functional team in a matrix environment. Excellent written and verbal communication skills, including facilitation and presentation skills.2012-04-05 19:44:51United StatesAmgenCalifornia13445BRCABothell, CA27668144http://www.amgen.jobs/xml/27668144/jobDEUMunichAuto req 15073BR Job Posting Title Praktikant für die Medizinische Abteilung Career Category Medical Services Employee Subgroup Co-Op FT Salaried Country (State/Region) Germany Location (City) Munich Amgen Job Description Amgen ist weiter auf Wachstumskurs und steht vor der Einführung mehrerer innovativer Produkte. Wir bieten motivierten und leistungsorientierten Persönlichkeiten Gelegenheit, in einem internationalen,dynamischen und innovativen Umfeld erste berufliche Erfahrungen zu sammeln. Wir suchen ab Mai 2012 einen engagierten und motivierten Studenten der Pharmazie, Humanbiologie, Biologie, Biochemie oder Medizin als Praktikant (m/w) im Bereich Medizin: Lernen Sie zwei Bereiche unserer medizinischen Abteilung kennen: Bereich Medical Communications (60%): o Überblick des Tätigkeitsspektrums wissenschaftlicher Produktexperten o Wissenschaftliche Präsentationen o Literaturzusammenfassungen o Kongressberichte o Veröffentlichungen Bereich Regional Medical Project Management (40%) o Überblick des Tätigkeitsspektrums der regionalen medizinischen Projektleiter Basic Qualifications • Naturwissenschaftliches Studium, Vordiplom vorausgesetzt • Gute Kenntnisse im Umgang mit dem PC (MS Office) • Sehr gute Deutsch- und Englischkenntnisse - schriftlich wie mündlich • Gute kommunikative Fähigkeiten - schriftlich wie mündlich • Neugier und rasche Auffassungsgabe • Initiative, Kreativität, Teamgeist, Belastbarkeit und Flexibilität • Zeit für ein 6-monatiges, vergütetes Praktikum, gerne auch Pflichtpraktikum Preferred Qualifications Was wir Ihnen bieten: Sie gewinnen hervorragende Einblicke in das weltweit größte Biotechnologie-Unternehmen und erhalten die Gelegenheit, Ihre fachlichen Fähigkeiten zu erweitern. Im praktischen Arbeitsumfeld können Sie täglich Ihre persönlichen und sozialen Kompetenzen weiter entwickeln. Unser Arbeitsstil ist von Offenheit,Fortschritt und dem Willen zum Erfolg geprägt - der Teamgedanke wird groß geschrieben. Bitte übermitteln Sie uns Ihre Bewerbung online über unser Karriereportal. Selbstverständlich bewahren wir alle datenschutzrechtlichen Bestimmungen. Für Fragen vorab steht Ihnen Frau Martina Rech (Staffing Manager) unter der Telefonnummer (089) 14 90 96-11 12 gerne zur Verfügung.2012-04-05 19:44:40GermanyAmgenNone15073BRNoneMunich, DEU27668141http://www.amgen.jobs/xml/27668141/jobUSAThousand OaksAuto req 14591BR Job Posting Title Sr Mgr Finance Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position provides financial, analytical and decision support to the Oncology Business Unit for Neulasta, Neupogen, and Vectibix in Global Commercial Operations – Financial Planning & Analysis. The position supports revenue modeling for the monthly close, latest estimates, annual planning and long range planning activities. This role requires the ability to develop an understanding of the business drivers, analyze and clearly communicate financial implications of the changing reimbursement environment, build effective relationships with the business unit leaders, and analyze and clearly communicate financial results and direction to client groups and assess competitive threats. The position will also be intimately involved in the analysis, development and implementation of various productivity initiatives.This position will also interact with numerous functions, including the Brand team, Pricing, Contracting, Forecasting, Sales, Global Marketing, and Reimbursement. Additional responsibilities include financial modeling, preparation and presentation of results and ideas to senior management and performing regular account analyses to anticipate and resolve issues. The successful candidate will demonstrate the ability to take initiative and work with a minimum of direction, to provide leadership and key support on multiple projects, to manage cross-functional teams, to formulate and clearly deliver complex information, issues and recommendations in both written and oral form to senior management, and develop and use complex financial models to facilitate decision making. Excellent analytical skills, strong proficiency with Excel and PowerPoint, a thorough understanding of corporate finance concepts, and provocative and critical thinking are essential. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications 6+ years experience in functions requiring business / financial analysis and presentation of results and recommendations to Senior Management. Proficiency with Excel and PowerPoint is a must2012-04-04 03:03:30United StatesAmgenCalifornia14591BRCAThousand Oaks, CA27630480http://www.amgen.jobs/xml/27630480/jobUSAThousand OaksAuto req 14603BR Job Posting Title Accounting Sr Mgr Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The general responsibilities of this position include: external financial reporting, researching, analyzing and providing guidance on reporting matters and contributing to process improvements as they relate to external reporting. Specific Responsibilities: •Contribute to the preparation of quarterly and annual SEC filings (10-Q, 10-K, etc.), which involves working with a cross-functional team including Legal, Investor Relations, Corporate Communication, Financial Planning & Analysis (FP&A) and others. •Contribute to the preparation of other external reports including the Annual Report, Certain subsidiary or branch financial statements etc. •Ensure that financial statements comply with US GAAP and SEC rules and regulations and meet the highest standards of relevance, transparency, and clarity. •Work closely with Investor Relations and FP&A to support quarterly earnings release process and other internal and external communications with a primary focus on accuracy and appropriateness of financial and accounting related amounts and disclosures. •Contribute to the Company’s positions on accounting and reporting issues raised in SEC comment letters and other external inquires. •Monitor accounting standards and rule changes (FASB, SEC, etc.) and participate in assessing their impact on the Company’s disclosures. Stay current on all pending accounting and disclosure issues that may affect Amgen through attending external seminars, holding discussions with counterparts in other pharmaceutical companies, and monitoring the regulatory filings of other public filings of other companies. •Provide disclosure guidance to management and others and help identify and resolve related issues. •Contribute to the development of accounting and financial reporting policies. •Contribute to communication of financial results to the Audit Committee of the Board of Directors. •Contribute to process improvement initiatives in the external reporting area, including those involving a broad spectrum of stakeholders. Basic Qualifications Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree or & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications CPA designation; and -Minimum 8 years of directly related experience in accounting and financial reporting. -Combination of public accounting and financial reporting experience. -4-6 years Big 4” accounting experience is preferred. -Demonstrated leadership capability and team leader/player skills. -Strong interpersonal skills; ability to influence personnel across functions and levels. - Strong written, verbal communication, problem-solving and presentation skills. -Pharmaceutical/Biotech experience. -Strong Excel and PowerPoint skills. -Strong project management skills.2012-04-04 03:03:29United StatesAmgenCalifornia14603BRCAThousand Oaks, CA27630479http://www.amgen.jobs/xml/27630479/jobIRLCorkAuto req 14214BR Job Posting Title Engineering Projects Mgr Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Cork Dublin Field Based Dun Laoghaire Amgen Job Description Engineer Project Manager - Packaging Amgen Dun Laoghaire - Dublin Overview: This position will be part of the packaging group and be responsible for the execution of all projects in that area. The equipment engineer reports to the Sr. Manager Manufacturing –Packaging. The candidate will apply technical expertise in the management of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems, facilities or processes. Responsibilities include: The chosen candidate would typically be involved in activities such as (but not exclusively); • Engineering Project lead for Packaging • The provision of manufacturing input to all capital projects relating to the area. • The definition and scoping of all process improvement activities relating to the area. • All design reviews associated with equipment purchases. • The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad. • Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site. • Continuous improvement programs • Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals. • Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering (Mechanical, Electrical or Chemical) • Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries. • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. • Significant relevant industrial project experience Preferred Qualifications Preferred Experience • Typically 8+ years engineering experience in an aseptic pharmaceutical environment • Significant experience large project related activities including GMP qualification experience.2012-04-04 03:03:14IrelandAmgenNone14214BRNoneCork, IRL27630466http://www.amgen.jobs/xml/27630466/jobUSAThousand OaksAuto req 14421BR Job Posting Title Biosimilars Strategic Planning & Ops Director, Commercial Career Category Corporate Services Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Department Overview: Amgen Biosimilar Strategic Planning & Operations is accountable for: • Amgen’s corporate (policy and competitive) preparation for biosimilars entry in the U.S. • Oversight and coordination of global initiatives to retain and improve biosimilars policy in EU, Latin America and Asia • Support and integration of our brand and biosimilars businesses Job Summary: Lead corporate level (e.g. non-brand) commercial preparation for biosimilars; coordinate with biosimilars communications and regional leads, brands, payer marketing and biosimilars unit to execute an integrated communications platform Role Purpose and Scope: Responsible for organizational preparation for intense but highly constrained competition and delivering a coordinated ‘platform’ of competitive actions/differentiation opportunities at the corporate and cross-brand level, this role will provide input and assistance to PSTs and brands on opportunities to differentiate individual products in context of system-wide changes in global healthcare environment • Contributes to organizational thought leadership • Contributes to business results through quality of results, advice and decisions related to the operations of the discipline • Contributes through application of expertise associated with a professional body of commercial knowledge to complete tasks, assignments and/or long-term projects • Develops mutually beneficial strategic alliances with internal and external contacts • Will have direct and/or dotted line reports • Financial approval consistent with grade ($250,000+) Responsibilities: Commercial Lead & Biosimilar SME: • Partner with legal and regulatory team members to fully understand the relevant laws, regulations and precedent that define our freedom to operate commercially • Collaborate to identify and develop appropriate mechanisms to compete effectively with biosimilars • Collaborate on comprehensive recommendations for CEO staff decision-making • Ensure integration with brand leadership • Participate in relevant commercial and brand sub-teams, meetings and workshops to coordinate corporate activities and alignment Corporate Commercial Preparation: • Identify and develop potential strategies and tactics to differentiate from a new type of competition at the corporate or multi-brand level • Identify key milestones and/or inflection points for overall evolution of biosimilars markets in EU, Canada, U.S. and EM • Establish broad intake scope; narrow opportunities to those suitable within current timing, legal and P&L constraints • Ensure integration with brand leadership • Collaborate with biosimilars team SMEs to develop proactive opportunities • Partner with biosimilars communications and ‘Made by Amgen’ team to execute approved campaigns Interpret Competitive Intelligence: • Support brand teams with detailed analysis of CI in context of protein science, clinical development outcomes and established regulatory precedent • Partner with CI to develop clear and contemporaneous reports for brand teams, payer teams and executive management Strategic Planning and Operations: • Develop and share broadly a comprehensive understanding of the future landscape for biosimilars and underlying behaviors of key decision makers • Understand potential dimensions along which Amgen can successfully differentiate and compete with a biosimilar or other ‘closely related’ product • Develop and maintain a body of benchmarks and case studies relevant to emerging biosimilars competition Policy Assessment and Implications: • Partner with policy director to predict, understand and translate emerging implications of rulemaking • Identify future policy needs and timing Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience Preferred Qualifications • Masters or Doctorate in protein science or related technical discipline • Biologic drug commercialization, sales and marketing experience • Proven track record of collaborative and constructive relationships with legal and regulatory subject matter experts • Significant EC/EMA and U.S. commercial experience and market analysis • Extensive analytics and market research experience; highly competent working within global compliance requirements • Direct knowledge of global biosimilars marketplace and recent commercial strategies and tactics • In depth knowledge of commercial communications • In depth knowledge of EU and U.S. laws and regulations related to commercial communication, promotions and enforcement • Knowledge of or experience in U.S. and/or EU pricing and competitive dynamics2012-04-04 03:03:13United StatesAmgenCalifornia14421BRCAThousand Oaks, CA27630465http://www.amgen.jobs/xml/27630465/jobCZEPragueAuto req 13584BR Job Posting Title Product Mgr Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) Czech Republic Location (City) Prague Amgen Job Description Drives motivation of sales force towards brand aspiration (cycle and launch meetings) Develops and implements Country Brand Plan in full congruence with International Brand Plan Designs and executes promotional activities (detail aids, message scripts, advertising, congresses, etc.) in line with international branding and key messages Develops LRP with Business Planner Proposes national sales target and achieves agreement with Business Unit Leader and Sales/District Managers Partners with international PM Translates/implements international brand campaign locally Analyses market research and develops POA Coordinates competitive intelligence and drives competitive action plans Partners with the Medical Affairs Manager to optimise the brand performance (goals of clinical trials, KOL development, etc.) Agrees with other PM in Franchise Team on joint projects Recruits and manages external vendors Identifies business opportunities and develops business cases Basic Qualifications Minimum Requirements Academic education or experience from similar positions Minimum 5 to 8 years of experience in industry 1 to 3 years as a Pharmaceutical Sales Representative Minimum 2 years of experience as a Product Manager Fluency in English, both oral and written communications Financial and budgeting skills and experience Documented track record of product launch Computer skills (MS Office programs) Tenure at last two jobs for at least 2 years each2012-04-04 03:03:01Czech RepublicAmgenNone13584BRNonePrague, CZE27630464http://www.amgen.jobs/xml/27630464/jobUSAThousand OaksAuto req 15078BR Job Posting Title Principal Packaging Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position reports into the Primary Container Engineering group under Drug Product Engineering in Thousand Oaks. This position will be required to apply advanced and diverse engineering principles to execute the proper design, qualification and implementation of Primary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position. This position will be located in Thousand Oaks, California. This position will be required to: 1) Qualify fill finish processes with cartridge systems. Including cartridge preparation, filling and sealing in pilot to commercial scale. 2) Evaluate, recommend and select primary packaging materials for large and small molecule drug products. 3) Write test and execute protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials. 4) Write Technical Specifications and Bill of Materials 5) Perform technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes 6) Ensure cGMP and regulatory compliance are met 7) Author primary container sections for all global market applications and support filing activities 8) Collaborate with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications MS or Ph. D in Materials Science, Chemical Engineering or Mechanical Engineering 6 to 10 years (or more) of experience with 4+ years within the Pharma/Bio industry Demonstrated General Competencies/Skills: 1. Independent thinker with demonstrated skills working in teams or leading project teams 2. Strong Interpersonal and communication skills Desired Technical Competencies/Skills (any one or multiple combination thereof): 1. Demonstrated experience with CAD software for modeling container closure systems. Example: Use of Solid WorksTM drawings to assess mechanical interfaces for device integration as well as support for specifications, standards, methods as well as concept modeling. 2. Design for manufacturability experience (6 Sigma, FEA, etc)2012-04-04 03:02:49United StatesAmgenCalifornia15078BRCAThousand Oaks, CA27630458http://www.amgen.jobs/xml/27630458/jobUSAThousand OaksAuto req 14418BR Job Posting Title Biosimilars Strategic Planning & Ops Director, Technical Policy Career Category Corporate Services Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Department Overview: Amgen Biosimilar Strategic Planning & Operations is accountable for: • Amgen’s corporate (policy and competitive) preparation for biosimilars entry in the U.S. • Oversight and coordination of global initiatives to retain and improve biosimilars policy in EU, Latin America and Asia • Support and integration of our brand and biosimilars businesses Job Summary: Provide team leadership on critical policy measures and inform corporate strategy on appropriate methods to support Amgen’s scientific principles as well as originator and biosimilars objectives. Conduct detailed analysis of biosimilars policy. Provide external engagement leadership; represent Amgen and industry in media, communications; publication development, trade association leadership Role Purpose and Scope: Responsible to shape scientific policy by providing technical expertise and global leadership on biosimilars policy matters, this role will translate science for lay audiences; develop, review and deliver external technical communications; conduct policy/regulatory engagement and trade association leadership; support legal analysis • Contributes to organizational thought leadership • Contributes to business results through quality of results, advice and decisions related to the operations of the discipline • Contributes through application of expertise associated with a professional body of scientific/technical or policy knowledge to complete tasks, assignments and/or long-term projects • Develops mutually beneficial strategic alliances with internal and external contacts • Will have direct and/or dotted line reports • Financial approval consistent with grade ($250,000+) Responsibilities: Manage external government and policy communications: • Influence a broad spectrum of stakeholders toward setting science-based standards for biosimilars • Publish scientific findings, best practices and science-based positions • Represent Amgen and the innovator industry in policy testimony, media interactions and public fora • Lead trade association key issue and/or technical teams • Develop collaborative alliances with internal and external scientific experts Team Leadership and Collaboration: • Act as comparability / biosimilarity subject matter expert for Amgen external communications reviews • Define Amgen positions on the scientific, medical and regulatory aspects of biosimilars and the establishment, improvement and reinforcement of sound scientific policy for biologic medicines • Work in multi-disciplinary team alongside medical, legal and regulatory on analysis and position development Technical Expert: • Evaluate biosimilars policy for scientific rationale and basis • Coordinate characterization and analysis of biosimilars products • Develop internal and cross-team communication of Amgen and industry experience in developing and manufacturing biologics, and now biosimilars Strategic Planning: • Contribute to organizational thought leadership • Work in partnership with team leadership to develop plans that support corporate objectives • Collaborate with law to prepare for areas in which regulatory and judicial clarity may be needed Integrated Policy & Corporate Execution: • Develop recommendations for science-based policies that put patient safety first • Work with Competitive Intelligence to connect data points into information and knowledge • Contribute to executive decision-making through application of expertise and professional body of scientific/technical knowledge Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience Preferred Qualifications • Masters or Doctorate in protein science or related technical discipline • Biologic drug development, manufacturing and/or quality experience • Significant EC and EMA experience • Direct knowledge of global biosimilars policy • In depth knowledge of WHO scientific biosimilars standards • In depth knowledge of EU laws and regulations related to biosimilars • Knowledge of or experience in development of U.S. and/or EU biosimilars products2012-04-04 03:02:48United StatesAmgenCalifornia14418BRCAThousand Oaks, CA27630457http://www.amgen.jobs/xml/27630457/jobUSAThousand OaksAuto req 14574BR Job Posting Title Sr Packaging Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position reports into the Device & Package Engineering (D&PE) group under Global Drug Product and Device Development in Thousand Oaks, CA. The position falls within 2 different categories in D&PE: Pre-Commercial and Commercial Engineering, supporting global supply, launch delivery, partnerships/acquisitions and devices. This position will apply advance and diverse engineering principles to execute the design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position. This role requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment. This position is responsible and accountable for the following: - Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product. - Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials. - Write Technical Specifications and Bill of Materials - Representing PD&E in Drug Product and Global Operation Teams - Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes - Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes - Ensures cGMP and regulatory compliance are met - Ensures that change control procedures are followed working with QA and Regulatory to implement changes - Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed - Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities. - Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems. - Oversees project implementation of critical new package platforms. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications - MS in Packaging, Engineering or Life Sciences - 7 or more years of packaging/engineering experience with 4+ years within the Pharma/Bio industry Demonstrated Competencies/Skills: - Independent thinker with demonstrated skills working in teams or leading project teams - Strong Interpersonal and communication skills2012-04-04 03:02:42United StatesAmgenCalifornia14574BRCAThousand Oaks, CA27630449http://www.amgen.jobs/xml/27630449/jobUSAThousand OaksAuto req 14414BR Job Posting Title Principal IS Architect (Enterprise IS Technology Services Principal Design Engineer) - Security Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This Principal Design Engineer for Amgen's Enterprise IS Technology Services (EISTS)Design & Engineering is responsible for the development, delivery, and life cycle of Amgen IS Infrastructure technologies in identity, business partner connectivity, messaging and communications, security, and related areas. As a multi-disciplinary expert, the successful candidate must provide Engineering direction across the organization in their areas and relationships to it from other areas. This position will deliver timely designs and implementations from the existing technology portfolio, create new solutions, and maintain the technology portfolio life cycle. Job Responsibilities • Be accountable for developing, delivering and maintaining an integrated set of designs, detailed specifications, roadmaps and program delivery for solutions from their areas. • Ensure the relevance and completeness of designs and delivered solutions to EISTS service owners. • Accountable to ensure IS projects leverage and maximize value Engineered solutions from their portfolio of technologies through strong collaboration within EISTS and across IS. • Provide technical leadership and implementation support to projects requiring cross-functional integration expertise, including co-development of project plans. • Lead the introduction of new EISTS Technologies into their portfolio to enable business value driven innovation while maximizing organizational effectiveness and efficiency. • Maintain the technology portfolio life cycle for their areas within EISTS, including driving the retirement of obsolete or declining technologies and delivery of successor technologies to enable efficient service provision and minimize risks. Lead alignment of services and operations for their areas within EISTS, to increase efficiency and reduce the risk of unmanaged faults in the service and operational pipeline. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Master’s degree • Bachelor’s Degree in Information Systems, Computer Science, or Electronics • 10 + years experience working within Information Systems • 7+ years experience delivering large and small IS infrastructure technology solutions in global companies using Information Technology and Services in regulated environments. Additional experience with technology supply and sourcing companies a plus. • 5+ years developing integrated business-to-business and business-to-consumer solutions, including detailed technical experience with key Internet technologies and protocols (e.g. TCP/IP, HTTP, SMTP, DNS). • 5+ years experience with security and identity infrastructure, including LDAP, Microsoft Active Directory, PKI, and SSL/TLS. • 5+ years experience with service design and operational alignment. Specific experience applying ITIL to infrastructure service delivery and operation is a plus.5+ years biotechnology or pharmaceutical experience are a plus. • Strong leadership and communication skills to convince all stakeholders on programs and portfolio investments. • The ability to function in multiple roles based on project demands. • Strategic delivery experience and ability to facilitate alignment and investment across multiple geographies, functions, and disciplines. • Excellent oral, written and interpersonal communication skills. • Experience with a range of IT service, architecture, engineering, and design frameworks and languages, including UML and/or BPMN a plus. • This position requires a senior and credible IS Infrastructure technology design and delivery engineer, with broad experience and demonstrated success. It requires a passion for Information Technology and engineering, in depth understanding of Infrastructure technologies, of technology integration, and of industry practices. • Learning agility, technical excellence, discipline and the capability to engage and collaborate across the IS Function in a relationship based organization to drive change and continuous improvement at all levels are essential attributes. • This individual will leverage his/her extensive experience in designing and delivering global information infrastructure systems in a regulated environment for the Enterprise and a diverse range of specialized business needs and partner with business IS and other Enterprise shared services2012-04-02 23:26:51United StatesAmgenCalifornia14414BRCAThousand Oaks, CA27593255http://www.amgen.jobs/xml/27593255/jobUSAThousand OaksAuto req 14573BR Job Posting Title Principal IS Business System Analyst (Enterprise IS Technical Services Programs Portfolio Planning Senior Manager) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Enterprise IS Technical Services (EISTS) Portfolio Planning Senior Manager is responsible for planning and coordinating resources for all EISTS project resources, reporting to the Executive Director EISTS Programs and Strategy. The position combines both resource planning and execution and financial planning responsibilities. Job Responsibilities: • Coordinates with the Program Leads, Operations Service Owners, and Client Services Managers to develop and manage project and program resources, cost estimates and resource allocation. • Coordinates with Finance and other portfolio governing bodies to keep current the latest estimate annual budgets, resource plans, and other portfolio related activities. • Works with key stakeholders to continuously optimize project resourcing. • Communicates status of overall EAS portfolio and facilitates communication of projects to EISTS leadership and other key stakeholders. • Understands and communicates changes to budget and monitoring processes and deliverables. As required, provides training to EISTS staff on project budget processes. • Develops improvement techniques within Programs management to achieve process efficiencies, innovation, and operational excellence. • Manages the EISTS portfolio using Amgen’s EPPM portfolio management tool. Supports PMs with the creation and editing of projects in the tool. Ensures project change and close out notifications and done in a timely manner. • Facilitates the project resource planning and budget initiation and approval and supports project managers through the capital funding process. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Master’s degree • Bachelor’s Degree in Engineering, Information Systems, Computer Science, Business, Finance or the Life Sciences. • Strong financial background • 5 + years experience working within information systems and/or project management • Strong oral, written and interpersonal communication skills • Knowledge of Amgen Business and IS practices as well as previous experience with global projects • Sound experience managing of IT, business analysis or business change • IT Financial management expertise including competency in business analysis and business case development. • Proven influencer and communicator with stakeholders at all levels. • Delivering results: ability to plan and organize self and work in order to achieve objectives and targets. Is determined to deliver outcomes and is able to overcome obstacles in order to move forward. Accountable for the delivery of outcomes, strives to meet and exceed the expectations of customers. • Influencing and negotiating: can influence and challenge at executive level. • Working with others: ability to work effectively with colleagues, managers, suppliers and stakeholders. Understands the importance of developing effective partnership relationships with key suppliers.2012-04-02 23:25:46United StatesAmgenCalifornia14573BRCAThousand Oaks, CA27593245http://www.amgen.jobs/xml/27593245/jobUSAThousand OaksAuto req 14575BR Job Posting Title Sr Mgr GRAAS Operations (Strategy and External Operations) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role shapes and drives key GRAAS and corporate initiatives delivering productivity and operational excellence, in particular sourcing. - Influence and execute transformational business strategies particularly Amgen’s global operating model and sourcing - Deliver productivity/op-ex initiatives including design and leadership of selected process improvements in partnership with GRAAS and corporate leaders - Lead all aspects of financial value capture from these initiatives including financial modeling, allocations, NPV recovery, and support budgeting and planning - Provide execution of global sourcing strategies, and other GRAAS strategies Key Activities of this role include: -Supplier Management - Lead ongoing oversight of supplier engagement - Review and approve metrics/targets for supplier operations - Lead/participate in resolution of business / financial / productivity or site operatins issues with suppliers - Support/lead management of supplier operations (i.e. scheduling, expenses, status reporting, issue/risk management etc.) - Support monitoring of completion of work in accordance with service level agreements (SLAs) and contracts - Leverage best practices in project management to ensure quality performance from supplier - Full ownership of the financial models used/needed for GRAAS to oversee productivity targets, financial value capture, and supplier financials - Review and maintain KCI, KPS, Metrics, compliance related documentation, and conduct / complete RCA / CAPA activities - Oversee supplier operational/process improvement - Strategy and External Operations - Monitor and ensure achievement of desired productivity benefits from strategic initiative. Support development and maintenance of GRAAS Performance Scorecards. Develop financial and operational models to ensure achievement of business benefits. Help secure ELT approval of strategic initiatives by determining validity, expected ROI, and risk:benefit effects - Hands-on leadership of strategic programs and process improvements through planning and implementation. Support/drive various new outsourcing initiatives and partner with GRAAS functions - Support other GSEO projects driving operational excellence in alliances, mergers, and acquisitions Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree or & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience AND - 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Knowledge and Skills: - Interacting and communicating with senior executives on strategic subjects - Communicating and presenting clearly on strategic and business issues - Motivating and leading teams and projects in a global complex matrix environment - Excellent interpersonal, organizational, supervisory, collaboration and leadership skills - Experience managing cross-functional policy and business initiatives - Experience implementing business change - Crating and updating financial modeling and business value forecasting - Knowledge of strategic management, performance improvement , and change management models - Extensive knowledge of continuous improvement methodologies - Proficiency in anticipating and resolving problems - Understanding of information technology and R&D systems including safety and regulatory technologies - Knowledge of process improvement methodologies - Knowledge of project management tools and methodologies - Experience managing and working with various vendors - Knowledge of communications tools and processes (SharePoint) - Strong computer literacy, including word processing, presentation, spreadsheet, project and web products - Experience in life sciences or medically related field: knowledge of the bio/pharm industry - Experience engaging in regulatory and safety policy development and implementation - Leading at a functional level and working in a global matrix environment - Experience working in a global environment Competencies: - Leadership skills - Conflict management - Managing diversity - Listening - Managing and measuring work - Building effective teams - Problem solving - Ability to keep the big picture" in mind while dealing with the details - Ability to envision and implement business process solutions - Good written and verbal communication sills - Relationship building skills2012-04-02 23:24:51United StatesAmgenCalifornia14575BRCAThousand Oaks, CA27593239http://www.amgen.jobs/xml/27593239/jobUSAField BasedAuto req 14628BR Job Posting Title Sr Biopharmaceutical Rep, Inflammation - Green Bay, WI Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Wisconsin Location (City) Field Based Amgen Job Description Territory – #33408 Green Bay, WI covering • Northern WI and the Upper Peninsula of MI including these cities Rhinelander, Marinette, De Pere, Appleton, Manitowoc, Menasha, Neenah, Oshkosh, Green Bay, Wausau, Fond du Lac, Beaver Dam, Marshfield and Sturgeon Bay in WI and Marquette/Saint Francis in MI Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. As a Sr Biopharmaceutical Rep, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Basic Qualifications Bachelor’s degree & 2 years of directly related experience OR - Associate’s degree & 6 years of directly related experience OR - High school diploma / GED & 8 years of directly related experience Preferred Qualifications 2+ years of sales and/or marketing experience within pharmaceutical, biotech or healthcare industries - Previous experience selling in the Rheumatology and/or Dermatology market. - Expert local knowledge in the primary care or specialty market. - Successful launch experience in a highly competitive market. - Outstanding business acumen including experience with: - Medicare Part B - Contracting - Managed Care or pull-through - Capital equipment or durable medical device sales - Proven strategic account management Core Competencies: - Planning and Organizing Work - Engaging Others Through Effective Communication - Drive to Achieve2012-03-31 22:32:30United StatesAmgenWisconsin14628BRWIField Based, WI27542773http://www.amgen.jobs/xml/27542773/jobITAField BasedAuto req 14569BR Job Posting Title Product Specialist Oncology Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) Italy Location (City) Field Based Amgen Job Description The Italian affiliate Amgen Dompè S.p.A is currently is looking to hire a Product Specialist for Oncology. The area of responsibility will be: a part of Naples and Caserta province. Reporting to the Manager District Sales (Campania) he/she will be responsible for: • Maximizes sales of Amgen’s products in territory - Achieves sales targets - Delivers key messages - Collaborates with manager to implement agreed points of action in line with marketing strategy - Identifies and establishes high quality customer relationships and internal collaboration - Knows in-depth knowledge of the product(s), market , stakeholders and competitors - Works within agreed budgets - Lives the Amgen Value Key Activities: • Collaborates with manager to develop and implement territory points of action (POA) and key account plans. Achieve POA. • Evaluates progress vs. plan monthly and agrees to course corrections with manager • Contributes to Cluster/Territory Teams Collaborates (Medical Affairs/Key Account Manager, etc.) to agree on key account plan objectives/responsibilities • Engages with peers and District Manager to learn best practices • Demonstrates an understanding of industry and healthcare trends, of how retail practices, clinics and hospitals operate. • Identify and gather competitive information • Follows through on customer commitments and requests in a timely fashion • Reports customer activity in the CRM system and ensures customer profiles are kept up-to-date • Demonstrates an understanding of Amgen Performance 4 selling platform to satisfy customer and Amgen needs • Operates within the agreed expense budget aligned with POA priorities • Seeks advice and assistance to organize activities • Continuously develops and improves product knowledge, communication and selling skills through self-learning and active participation in agreed training programs. Drives own development Basic Qualifications • Scientific Academic Education or similar • Industry experience for at least 1 year from similar position • Native in Italian • Office Programs as Word, Excel, Outlook. • He/she to be resident preferably in Naples or Caserta. Preferred Qualifications • Knowledge in therapeutic area of Oncology/Hematology • Fluency in English, in written and oral communication • Documented successful experience from sales, preferably within larger Pharmaceutical companies • Experience in CRM tools We will also consider candidates with less experience but with high potential to grow and learn quickly within this great opportunity at Amgen.2012-03-30 04:58:27ItalyAmgenNone14569BRNoneField Based, ITA27508347http://www.amgen.jobs/xml/27508347/jobUSAThousand OaksAuto req 14301BR Job Posting Title Mgr Manufacturing Career Category Operations Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The successful candidate will be leading a team of experienced manufacturing associates responsible for downstream purification operations to manufacture clinical GMP drug substance. The manager will champion a safe and compliant production environment through on the floor presence. The manager will be an active participant in continuous improvement programs and will translate them onto the manufacturing floor. Responsibilities include: • Selection, training, oversight, performance evaluations, staff relations and development of staff. • Ensures schedule adherence for tasks including but not limited to manufacturing, qualification, and maintenance activities. • Ensures standard operating procedures are accurate for executing unit operations, batch record review is completed accurately meeting disposition timelines, and non conformances are initiated and closed with right the first time documentation. • Utilizes appropriate systems for job duties (SAP, QMTS, and LIMS etc.). • Interacts with business partners and internal & external audit teams including regulatory agencies as directed. • Identifies and implements process and safety improvements and assists in the introduction of new products in the facility and new technology. • Interacts with business partners to assist with scheduling of maintenance tasks, engineering evaluations, quality control sample submission, and quality investigations. • Ability to communicate production floor and project work at different levels of management. • Ability to elevate to sr. and executive management critical and impactful to the business floor events. • Technically competent to make processing decisions. Ability to troubleshoot and perform initial assessment to events that have the potential to impact product quality. • Flexibility to perform shift work (day, swing, and grave shift) as dictated by business needs. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience AND • Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Bachelor's Degree in Life Sciences or Engineering. • Minimally 5 years of related manufacturing experience. • More than 3 years experience in a production floor lead or manager role. • Mechanical ability/expertise coupled with a solid understanding of downstream processes. • Ability to understand analytical methods in the manufacturing areas. • Demonstrated technical writing ability. • Demonstrated project management and presentation skills. • Demonstrated experience with continuous improvement methodologies.2012-03-28 21:29:29United StatesAmgenCalifornia14301BRCAThousand Oaks, CA27464087http://www.amgen.jobs/xml/27464087/jobUSAThousand OaksAuto req 14589BR Job Posting Title Regulatory Writing Sr Mgr Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The purpose of this group is to prepare scientific and regulatory documents that comply with global regulatory standards. This position could be located in Thousand Oaks California, South San Francisco California, or at a remote home office. Job Summary: Prepare and oversee the development of scientific and regulatory documents and oversee senior management approval of these documents. Serve as functional area lead on product teams. Train and mentor medical writers and manage the work of GRW staff. Assist with hiring and departmental governance and with resourcing therapeutic areas and project teams. Key Activities: - Independently write clinical study reports, Investigator Brochures, Summaries of Clinical Efficacy, Summaries of Clinical Safety, Summaries of Clinical Pharmacology, Summaries of Biopharmaceutics, Clinical Overviews, Tables of All Studies, briefing documents, Risk Management Plans, and Response to regulatory questions - Prepare and manage the development of other regulatory documents and CTD sections, as appropriate (Modules 2, 3, 4 and 5 for CTD, Risk Management Plans, Responses to regulatory agency questions, protocols, statistical analysis plans, FIH documents) - Formally review and approve all regulatory documents - Serve as the functional area representative and lead on product teams (ie, GDT, GCST, GRT) - Provide functional area input for Global Regulatory Plans, Global Development Plans, and team goals - Responsible for study timelines for regulatory documents - Participate in development of regulatory submission strategy - Manage medical writers (includes career development, conducting performance reviews, providing coaching and guidance) - Identify, assess, and oversee individual contractors, freelance, and temporary writers - Keep abreast of professional information and technology through literature, symposia, and conferences - Participate in departmental and cross-departmental initiatives - Provide innovation for improving departmental processes - Provide expertise and guidance on document design and principles of good medical writing to the department and product teams - Work with medical writers to establish project priorities - Oversee all decisions made by reports - Assist with budget Basic Knowledge and Skills: - Experience reading, understanding, and applying regulations to constantly changing - Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment - Experience understanding and interpreting data/information and its practical application - Excellent written/oral communication skills and attention to detail - Strong time and project management skills - Negotiating skills - Perseverance with a drive for results Basic Qualifications - Doctorate degree and 2 years of directly related experience OR - Master's degree and 6 years of directly related experience OR - Bachelor's degree and 8 years of directly related experience OR - Associate’s degree and 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - 8+ years experience in writing clinical and regulatory documents for all phases of regulatory submissions (INDs to NDAs) - Advanced knowledge of scientific/technical writing and editing - Advanced knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery - Understanding and application of principles, concepts, theories and standards of scientific/technical field - Knowledge of management skills and supervising the work of others - Understands the core business process and purpose of the functional area in Amgen's commercialization process - Strong Leadership in a team environment - Strong negotiator - Mentoring, training and directing others - Developing and delegating to direct reports with a drive for results2012-03-28 21:29:19United StatesAmgenCalifornia14589BRCAThousand Oaks, CA27464082http://www.amgen.jobs/xml/27464082/jobIRLDublinAuto req 13504BR Job Posting Title Sr Mgr Manufacturing - Vial Fill Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Sr. Manager Manufacturing - Vial Fill Amgen Dun Laoghaire - Dublin Overview: This position will report to the Director of Manufacturing. The ideal candidate will provide strong management and leadership in the Manufacturing – vial fill facility. Key Responsibilities: • Manage the Vial Fill Manufacturing Facility department. • Lead in the development of long range planning (LRP) to maintain the highest level of productivity. • Lead in the development of Manufacturing’s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals. • Develop, maintain, and justify the departments’ budgets. • Responsible for ensuring that all manufacturing is carried out under GMP conditions and in a safe working environment. • Support the plant in the project approval, prioritization, and implementation process. • Develop metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based on the benchmarking data. • Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the manufacturing department. • Assure the appropriate level of training is undertaken for all levels of the manufacturing syringe organization which may involve developing training material. • Responsible for attaining and improving site based metrics targets. • Responsible for recruiting talented staff into the facility and setting standards for their performance. • This position will need to complete some travel to the other Amgen sites over the next two years. * Other functions may be assigned. Basic Qualifications Basic Qualifications • Typically 8+ years of experience in facilities management position. With typically 4+ years experience supervising technical staff • Bachelor’s Degree or combination of education and/or years of experience. Preferred Qualifications Preferred Qualifications • Knowledge of conflict resolution • Ability to partner with other departments. • Analytical problem solving. • Considerable Organization skills. • Experience in coaching, mentoring and counselling. • Ability to deal with and manage change. • Ability to set goals. • Knowledge of applicable regulatory guidelines • Ability to use company compensation system including mentoring lower management levels when required. • Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.2012-03-28 21:28:53IrelandAmgenNone13504BRNoneDublin, IRL27464075http://www.amgen.jobs/xml/27464075/jobUSAThousand OaksAuto req 14171BR Job Posting Title Exec Dir Business Analysis & Info Career Category Marketing Employee Subgroup Executive FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description KEY RESPONSIBILITIES Functional Responsibilities • Lead and staff a team a team in designing and developing tools for market mix and ROI analytics on promotional investments including field force detailing, physician relationship marketing campaigns, digital media and direct to consumer advertising across the Amgen portfolio of brands. • Utilize understanding of pharmaceutical industry and decision support science tools to create a department vision and develop effective recommendations on promotional investments for the organization. • Serve as an advocate and drive use of the appropriate performance metrics and action standards required to assess value of promotional investments, and lead team in developing a management dashboard for continuous measurement of key activities across business units. • Develop and manage department budget and adhere to Amgen financial and budgetary policies and procedures. • Review bench strength of present organization and take necessary steps to ensure necessary talent is available and being developed. Recruit, select and promote people to create a diverse talent pool. Serve as a role model and mentor. Company-wide Responsibilities • Influence and facilitate decision making with a broad range of internal stakeholders including Sales and Commercial VPs, Finance, Business Analysis & Insights, Information Systems and Executive management on promotional investment decisions and business requirements. • Partner with Business Units and Finance executives to drive increased rigor in decision making through systematic evaluation of all key promotional tactics and structured problem solving approach. • Partner with Direct to Consumer team to develop approach for measurement of social media and continuous loop marketing. External Responsibilities • Develop mutually beneficial alliances with key strategic vendors to create and adapt the necessary tools for decision support modeling. Continuously evaluate vendors and their deliverables to ensure that they are delivering optimal value to Amgen and are aligned with Amgen compliance policies. • Collaborate with external vendors and team to develop test/control design for promotional experiments (e.g. inside sales team, DTC test markets) and provide competitive business insights and recommendations to key stakeholders. • Represent Amgen within the industry on management science and decision support function (Management Science Institute; key vendor customer summits). • Develop mutually beneficial relationships with external suppliers (ZS Associates; MuSigma; Impact RX). Basic Qualifications ? Doctorate degree & 6 years of directly related experience OR ? Master’s degree & 10 years of directly related years OR • Bachelor’s degree & 12 years of directly related experience AND ? 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications PROFESSIONAL EXPERIENCE / QUALIFICATIONS • Functional Experience: Minimum 7-10 years (ideally more) of demonstrated experience in operations research; applied mathematics; statistics; economics or a related discipline. The ideal candidate will have not only utilized these tools but will have also played a lead role in developing and implementing the required processes, tools, and techniques. • Industry Experience: The candidate should have experience in an industry and company which has placed a premium on applying deep analytical rigor to the analysis of marketing and sales investments. This experience does not need to have come from the life sciences industry, rather leading-edge experience in consumer, financial services, technology, and/or other industry sectors where this skill is well-developed will be most valued. Knowledge of pharmaceutical data sources would be a plus. • Leadership Experience: Excellent leadership, interpersonal, organizational and supervisory skills. Experience leading teams and projects in a globally complex matrixed environment. • Functional Skills: Deep knowledge of decision support models for promotional ROI, market mix and sales force optimization. Knowledge and expertise in digital media measurement highly desirable. • Business Skills: Proven track record in leading business recommendations and decisions through the application of management science techniques. Experience implementing business change. • Communication Skills: Excellent written and verbal communication and analytic skills. Experience interacting with and influencing senior executives on strategic initiatives related to promotional investments. EDUCATION • Masters degree (MS or MBA) with focus on operations research; applied mathematics; statistics; economics or a related discipline.2012-03-28 21:27:45United StatesAmgenCalifornia14171BRCAThousand Oaks, CA27464063http://www.amgen.jobs/xml/27464063/jobUSAThousand OaksAuto req 14277BR Job Posting Title Director Information Systems - Enterprise Application Services (Web & Collaboration Services) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This Director Information Systems role leads the Web and Collaboration Services Center of Excellence in Enterprise Application Services reporting to the VP IS, Enterprise Application Services. Collaborates with key stakeholders in the business and IS to create, manage and deliver the organization’s web, collaboration and social media strategy. Responsible for the delivery of all IS aspects of the strategy incorporating key business, technology and security drivers to ensure maximum business value. Job Responsibilities: • Provide strategic leadership and direction for the adoption of web 2.0 mobile and social media networking practices and technology. • Collaborate with business and IS stakeholders to establish effective business sponsorship and governance of key collaboration and digital platforms such as MyAmgen and Amgen.com as well as for Amgen external web platforms and associated websites. • Develop, execute and maintain IS mobile and web strategy aligned with business growth and productivity drivers. • Responsible for day to day operations and maintenance of the global web and collaboration platforms. • Manage platform strategy and associated technology lifecycle including regular maintenance and enhancement releases, lifecycle upgrades and continuous improvements to the user experience. • Responsible for the development of effective partnerships with vendors and outsourced providers to ensure enterprise class service delivery related to web and collaboration platforms. • Work with IS Information Security and Enterprise Architecture to ensure security of digital platform and applications. • Manage, mentor and develop enterprise web & collaboration staff to deliver the maximum value from web & collaboration services. • Support and contribute to Amgen’s Information Management Strategy. Design and implement a sustainable content lifecycle process that implements the information management strategy in Amgen’s enterprise web and collaboration platforms. • Collate data and produce reports related to collaboration and social media usage and adoption and present the analysis to management to demonstrate value. • With business stakeholders and Information Security, establish collaboration and social media usage policies and procedures for internal users. • Monitor trends in online community tools, trends, and applications and incorporate as appropriate into IS and business web, collaboration and social media strategies. Basic Qualifications Doctorate degree & 4 years of directly related experience OR Master’s degree & 8 years of directly related years OR Bachelor’s degree & 10 years of directly related experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Master’s degree Bachelor’s Degree in Engineering, Information Systems, Computer Science, Marketing or Communications 12 + years experience working within information systems and supervising staff Experience deploying web, collaboration and social media platforms in large enterprises Strategic leadership experience and ability to facilitate alignment across multiple geographies Excellent oral, written and interpersonal communication skills Possess functional knowledge or some experience with HTML, knowledge of search engine optimization and tagging, etc.2012-03-27 20:15:57United StatesAmgenCalifornia14277BRCAThousand Oaks, CA27423885http://www.amgen.jobs/xml/27423885/jobUSAThousand OaksAuto req 14514BR Job Posting Title Global Safety Sr Medical Scientist Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role provides content and technical support to the GST in the evaluation of safety data and production of GST deliverables under the supervision of the Global Safety Officer (GSO). Due to significant experience in the role from a scientific and technical perspective this role requires increased independence and leadership with less direct supervision of content driven activities by the GSO. The incumbent must be able to serve as GSO delegate for internal and potentially external Amgen meetings (Data Monitoring Committee, Ad-com representation). Key Activities: Support Global Safety Officer (GSO) in the clinical interpretation of safety signals and evaluations of aggregate safety data including analytical strategy and search methodology Responsible for producing presentations for Product Safety Review Meetings (PSRM) and other scientific presentations under the guidance of the GSO Contribute content support to the development of strategy and creation of product risk management plans, safety updates, safety assessment reports, and other GST deliverables Safety content and expertise in support of Investigator Meetings, Data Monitoring Committees and DRTs, responses to regulatory authorities, safety sections of clinical trial documents Basic Qualifications MD or DO degree from an accredited medical school Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications Advanced Education in Nephrology strongly preferred. Current registered medical license Board certified or Board eligible Accredited fellowship or clinical experience Clinical experience, including training Drug safety experience2012-03-27 20:15:04United StatesAmgenCalifornia14514BRCAThousand Oaks, CA27423850http://www.amgen.jobs/xml/27423850/jobUSASeattleAuto req 14549BR Job Posting Title Sr Scientist - Bioinformatician / Computational Biologist Career Category Scientific Employee Subgroup Salaried FT Country (State/Region) United States - Washington Location (City) Seattle Amgen Job Description The Department of Comparative Biology and Safety Sciences is looking for a highly motivated bioinformatician/computational biologist to contribute to its programs for toxicity screening and hazard identification in preclinical drug development. The successful employee will develop and utilize a variety of analytical approaches and computational tools to help integrate and analyze high volume data sets, including omics, next-gen sequencing, mass spectrometry, and selectivity data. In this position, the individual is expected to proactively support and lead selected projects. The employee will be responsible for enhancing in-house bioinformatics tools and databases and developing new methodologies for complex data analysis and visualization. Data integration, management, and visualization are anticipated to be a substantial component of this job and the employee is expected to provide leadership and expertise in these areas. An excellent team spirit, proactive attitude, and good communication skills are necessary. Basic Qualifications Doctorate degree & 2 years of scientific experience OR Master’s degree & 8 years of scientific experience OR Bachelor’s degree & 10 years of scientific experience Preferred Qualifications A PhD in Bioinformatics, Mathematics, Computer Science, Physical Sciences, or related fields with 3+ year working experience in biomedical environment is required. A strong knowledge in mathematical modeling, statistical analysis, and relational databases are expected. Proven track record of integrating and analyzing various types of large-scale biomedical data as well as omics data are essential. Ability to translate biological questions into computational work streams and the ability to translate the outcome of computational processes into biologically meaningful messages are highly desirable. Skills in algorithm development as well as high level scripting languages such as R, Matlab, or S+ are also expected. Software engineering experience in a team environment is a plus. A proven ability and willingness to work with multidisciplinary teams is essential. Strong written and oral communication skills, self-motivation, independence and leadership are required. Prior experience of drug discovery and development process and knowledge of technology platforms are preferred, but not required.2012-03-27 20:14:32United StatesAmgenWashington14549BRWASeattle, WA27423835http://www.amgen.jobs/xml/27423835/jobUSAThousand OaksAuto req 14519BR Job Posting Title Senior Manager, Pipeline Strategy and Portfolio Management Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Senior Manager is responsible for partnering cross-functionally to support portfolio management and pipeline strategy development processes across Amgen’s commercialization process. Responsibilities Product valuation and risk analysis • Work with Product Strategy Teams (PST) to assess the value, cost, and risk of alternative development options for R&D pipeline programs to support effective stage gate decisions • Conduct due diligence to ensure pipeline / project valuation inputs are consistent and aligned across Development, Commercial, Finance, and Operations • Ensure appropriate integration of cost, risk, and return inputs into key product development decisions at the therapeutic area and portfolio governance level • Employ decision analysis and probabilistic modeling methods to highlight key trade-offs across strategic alternatives and support recommendations for optimal strategy choice • Ensure Product Strategy Teams (PST) can effectively integrate and communicate the value, cost, and risk implications of product development alternatives and recommendations Portfolio management and analysis • Support development of TA strategy by conducting internal pipeline assessments, forecasting portfolio productivity and throughput, and identifying potential pipeline gaps • Support the pan-Amgen portfolio prioritization process by leveraging relevant measures of cost, risk, and value to analyze TA portfolio alternatives • Collaborate with commercial Finance to ensure Long Range Plan revenue submission is consistent with latest approved probability adjusted forecasts • Interface with key PST members to ensure project and pipeline assumptions are aligned with current thinking and recorded / captured appropriately • Interface with other members of the Pipeline Strategy and Portfolio Management team to ensure the TA pipeline is accurately represented in portfolio reports, historical pipeline metrics, and forward looking resource estimates Analytical frameworks and foundations • Drive improvements and enhance consistency in Amgen’s product valuation, methods, policies, and tools, integrating more decision analysis methods and creative analytical approaches • Support evolution of Amgen’s portfolio management framework through effective process design, problem solving, and change management efforts • Support improved application of valuation and portfolio management concepts across Amgen through informal coaching and formal training and development Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Advanced degree in science or business • 7 years or more in biotech / pharma or life sciences management consulting doing project portfolio management, strategic planning, resource management, decision sciences, and / or financial planning • Good understanding of clinical development, regulatory issues, and market dynamics in the pharmaceutical and biotech industry • Able to foster trusted relationships with key partners including Therapeutic Area leadership, product teams, Finance, etc • Demonstrated ability to apply decision analysis methods and financial valuation to complex product development and portfolio decisions • Prior experienced developing stochastic forecasting models (e.g. monte carlo, real options, etc) • Comfortable with ambiguous work assignments and experience managing change in a complex, matrix organization • At least 5 years in biotech / pharma or life sciences management consulting doing project portfolio management, strategic planning, resource management, decision sciences, and / or financial planning • Excellent analytical and presentation skills • Knowledge of advanced modeling and forecasting methods and tools • Excellent team work and ability to work effectively across functions and with partner organizations to meet deliverables2012-03-26 21:52:35United StatesAmgenCalifornia14519BRCAThousand Oaks, CA27400880http://www.amgen.jobs/xml/27400880/jobUSAThousand OaksAuto req 14453BR Job Posting Title Sr Associate IS Bus Sys Analyst Career Category Information Systems Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Partner with Quality, Operational Excellence, and Environmental Health and Safety functions managing their overall IS needs. Manage the ongoing expectations and prioritization of functional area requirements. Serve as business analyst engaging with key stakeholders to develop strategic vision, implement process improvements and manage projects within the IS portfolio. Key Responsibilities: • Gather business requirements, provide planning, design review, and lead testing during the implementation/deployment of solutions, enhancements and new releases • Communicate and manage the client area expectations in the delivery of IS solutions • Participate in cross-organizational and cross-departmental meetings to represent both business and IS stakeholders • Coordinate technical resources in the delivery of IS services • Participate in the implementation and/or communication efforts for new programs and processes • Ensuring that IS technologies and processes will be deployed and supported to meet business needs and objectives • Not only recommend appropriate technology, but also provide the organizational understanding to adapt recommendations that can be effectively implemented and adopted Basic Qualifications •Master’s degree OR •Bachelor’s degree & 2 years of directly related experience OR •Associate’s degree & 6 years of directly related experience OR •High school diploma / GED & 8 years of directly related experience Preferred Qualifications •Bachelor's degree in Engineering, Information Systems or Computer Science with 2 plus years related experience required. Advanced degrees and/or Life Sciences experience preferred. •Past experience working in a global environment •Knowledge of the pharmaceutical industry and current approaches to GxP computer related systems •Experience scoping, defining, planning, implementing and documenting business opportunities •Client management skills - ability to work with internal business functions to understand their business processes, manage scope of work expectations and suggest / recommend IS solutions •Ability to function in a matrix team environment •Experience with prototyping approaches to software development •Experience with system design, configuration and business processes in a drug manufacturing environment •Knowledge of technical diagrams, process flowcharting and project management using MS Office applications, including MS Project and MS Visio and similar applications •Proven delivery of a completed system or application as part of a project or developer’s team, preferably with an industry partner •Knowledge of Software Architecture and the structure of software solutions •Ability to master, with minimal support, new IS technologies and processes •Effective written and verbal communication skills •Excellent analytical, problem-solving, business analysis and decision-making skills •Able to multi-task and stay focused on priorities in a fast paced environment to meet deadlines, including the ability to be comfortable and function effectively in an environment of ambiguity •Strong team player who is able to collaborate with colleagues on complex tasks and can use influence to achieve the required results •Understanding of business intelligence and reporting technologies •Ability to participate/support efforts being run across multiple sites to ensure solutions satisfy local requirements •Should have experience with Enterprise systems, validation, testing and change control •Understanding of the ITIL process framework and outsourced resource support models •Knowledge of Rational Unified Process (RUP) and/or experience with formal SDLC project methodologies •Knowledge of IS quality and compliance policies, SOPs and associated documents. •Position may require 10-20% travel2012-03-26 21:52:14United StatesAmgenCalifornia14453BRCAThousand Oaks, CA27400867http://www.amgen.jobs/xml/27400867/jobUSAThousand OaksAuto req 13996BR Job Posting Title Principal Scientist - Medical Sciences – In Vitro Diagnostics Career Category Scientific Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description As a result of the ongoing success of Amgen’s comprehensive biomarker programs a new In Vitro Diagnostics (IVD) Group has been established in Medical Sciences. The IVD group is responsible for the transition of an exploratory biomarker to an IVD, working with other functions within Amgen to identify the diagnostic partner. The Principal Scientist is responsible for leading cross-functional teams required to successfully manage and execute these partnerships through not only regulatory approval in multiple jurisdictions but also its life cycle as a companion to Amgen’s therapeutic. This Principal Scientist will be a highly motivated individual experienced in diagnostic development of histochemical and cytochemical analysis and/or molecular genetic analyses. The employee would be experienced in the use of these types of diagnostic devices in laboratory practice as well as demonstrated expertise in and knowledge of regulatory submissions of in vitro diagnostic devices. The incumbant will also have excellent communication skills across a broad range of stakeholders being able to influence decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company. Basic Qualifications • Doctorate degree & 5 years of scientific experience OR • Master’s degree & 12 years of scientific experience OR • Bachelor’s degree & 15 years of scientific experience Preferred Qualifications • 5-10 years experience in industry • PhD • A demonstrated background integrating data from multiple sources and identifying critical process variables. • A solid record of establishing and reviewing complex plans for multiple projects or activities. This includes planning resource allocation and distribution and identifying contingency plans. • The ability to implement project plans comprehending resource, budget, facility and regulatory requirements to meet project goals.2012-03-23 21:26:45United StatesAmgenCalifornia13996BRCAThousand Oaks, CA27358480http://www.amgen.jobs/xml/27358480/jobNLDBredaAuto req 14343BR Job Posting Title IS Business Analyst Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Amgen Job Description The Information System (IS) Business Analyst is a functional analyst with client facing and supply responsibilities. This role will ensure a successful IS implementation by evaluating the principal business needs, challenging technical solutions and facilitating the change process. The person taking this role will be responsible for International OTC processes within a global context. This role will work in close coordination with other members of the Operations and SAP Center of Excellence teams in Europe and US. The Business Analyst will participate in gathering requirements, design development and the review of SAP Configuration. Primary Focus/ General Accountability: ? This role is responsible for leading and developing the further implementation of OTC processes (both SAP & non-SAP). This could involve working within the EDI space, so knowledge of this along with other interfaces to external 3rd parties is critical. ? Ongoing maintenance and configuration activities related to this space ? Lead the development, configuration and system integration for the implementation of OTC processes in a global environment. ? Act as in-house OTC subject matter expert and support ongoing activities. ? Provide 3rd level support for SAP OTC/BAR users. ? Lead / Participate in OTC change requests and projects. ? Analyze functional requirements and drive the development of detailed functional / configuration / systems specifications and documentation. ? Responsible for completeness and quality of functional design. ? Provide high-level estimates for design and implementation effort. Basic Qualifications ? Minimum 3+ years hands on experience in the SAP OTC implementation and configuration, specific knowledge on SD and other products within this space (XPI, iDocs and Xi). ? Must have a strong working knowledge of SAP SD ? Experience in global operating SAP OTC implementations. ? Experience in Business Process Analysis & Design to make the connection between SAP and 3rd parties’ distribution systems. ? Experience in testing and production delivery. ? Experienced in functional and technical specification development. ? Experienced in troubleshooting and resolving SAP functional problems. ? Understanding of complex interfaces between different SAP systems. ? Bachelor or Master degree, preferably in Commerce/Business, Engineering or Computer Science. ? Strong analytical skills. ? Strong teamwork skills. ? Strong written and oral communication skills. ? Experience working in a regulated industry (Biotech or Pharmaceutical Industry preferred). Preferred Qualifications Knowledge - Knowledge of computer validation concepts in compliance with FDA/EMEA and other regulatory requirements. Experience - Systems Design Analysis - Network Technologies - Web Technologies - Computer Systems and Security2012-03-22 18:52:24NetherlandsAmgenNone14343BRNoneBreda, NLD27320715http://www.amgen.jobs/xml/27320715/jobIRLDublinAuto req 14509BR Job Posting Title Engineer - Packaging Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Packaging Engineer Amgen Job Description Packaging Engineer - Process Development This position will be required to apply advance and diverse engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components, the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and processes, packaging equipment, components and packaging processes, material science and quality system is essential to the position. The position will leverage organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment. This position is responsible and accountable for the following: 1) Evaluation, recommendation and selection of primary and secondary packaging materials, equipment , and vendors 2) Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials / equipment. 3) Write Technical Specifications, SOP’s and Bill of Materials 4) Representing Process Development in Drug Product and Global Operation Teams as required 5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes 6) Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes 7) Ensures cGMP and regulatory compliance are met at all times 8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes 9) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities. 10) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems in a timely manner. 11) Excellent problem solving and RCA skills. Excellent report writing skills. 12) Support the NPI process 13) Effectively review and close out non conformances by CAPA 14) Participate in FAT, SAT Demonstrated Competencies/Skills: 1) Independent thinker with demonstrated skills working in teams or leading project teams 2) Strong Interpersonal and communication skills 3) Ability to multi-task and manage tight timelines 4) Excellent report writing skills 5) Proven problem solving skills and indepth knowledge of problem solving methodologies 6) Knowledge of Regulatory environment 7) Flexible and adaptive – this position will involve travel and shift work. Basic Qualifications Basic Qualifications • Degree / diploma in engineering discipline with 5 + years relevant pharmaceutical packaging experience Or • Degree / diploma in packaging technology / materials sciences with 5 + years relevant pharmaceutical packaging experience2012-03-22 18:49:02IrelandAmgenNone14509BRNoneDublin, IRL27320620http://www.amgen.jobs/xml/27320620/jobUSASouth San FranciscoAuto req 14252BR Job Posting Title Principal Scientist - Drug Development for Metabolic Diseases Career Category Scientific Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Amgen Job Description We are seeking a highly motivated individual to be one of the leaders in Amgen San Francisco engaged in drug development related to metabolic diseases. This incumbant will be expected to interact seamlessly and collaboratively with project leaders in metabolic and other functional areas to help guide efforts to discover novel therapeutics. The successful incumbant must have exceptional scientific leadership, managerial and verbal and written communication skills, and be able to function optimally in a team-based/collaborative environment. Additional the incumbant will have the ability to critically evaluate data and a thorough knowledge and understanding of the drug development process. Basic Qualifications - Doctorate degree & 5 years of scientific experience OR - Master’s degree & 12 years of scientific experience OR - Bachelor’s degree & 15 years of scientific experience Preferred Qualifications Ph.D. in Life Sciences, Pharmacology, or related discipline. 7+ years of relevant work experiences following post-doctoral training with world-class expertise in metabolic diseases for performing hands-on experiments in academia or industry Experience in the pharmaceutical or biotech industry Outstanding track record of successful research, including publication in peer-reviewed journals and patent filings Strong back ground in cell biology, various cell culture systems, expression systems, molecular biology, biochemical assay development, and good understanding of relevant in vivo models Ability to act as a scientific liaison and project facilitator and expertise in database management and project tracking Good written and oral communication skills Good organizational and multi-tasking skills2012-03-21 18:37:30United StatesAmgenCalifornia14252BRCASouth San Francisco, CA27297592http://www.amgen.jobs/xml/27297592/jobIRLDun LaoghaireAuto req 14194BR Job Posting Title Training and Development Manager Career Category Training Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description The Training and Development Manager will be responsible for developing partnerships with key clients while influencing and establishing operating standards and practices. To be successful in this role you will need to complete the following: • Under minimal supervision, partners with the client to apply human performance theory and needs analysis skills to analyze performance issues and identify solutions that support business needs. • When a training need is identified, can utilize instructional design and adult learning methodologies to design and develop solutions in a variety of delivery formats. • Manages assigned projects. • Works with internal clients to manage their curricula and assignments and ensure all training materials are integrated with Amgen’s learning management system per defined business processes. • Supports the gathering and evaluation of metrics that ensure the effectiveness of performance solutions and training materials. • Serves as an internal client’s first point of contact for performance and training questions. • Leads global training forum for client function and represents client during Operations global governance and prioritization processes. • Writes instructional materials, leader’s guides, etc, and able to modify existing material. • Develops and conducts Train-the-Trainer classes/support as needed. • Works with audit response teams to ensure appropriate actions are taken. • Provides proactive strategic planning to client regarding future performance needs and global curricula projects. • Serves on sustainment steering committee for applicable global programs. • Ensures that training content is current and reflects all technical and compliance standards. Basic Qualifications • Bachelors Degree or comparable professional experience in Instructional Design, Human Performance Technology, Life Sciences, or Business • 5+ years experience as a performance consultant, instructional designer, and/or curriculum developer • Knowledge of adult learning theory, instructional design, performance consulting, and needs analysis • Experience using ADDIE or other instructional design methodology in the creation of training materials • Experience supporting and/or creating materials for on-the-job training • 2+ year project management (managing projects, defining scope, overseeing budget, tracking milestones) • Travel, up to 10% Preferred Qualifications • 2 years experience in Microsoft Word, PowerPoint, and Excel • Any experience with business processes surrounding the use of learning management or training systems (i.e., SumTotal, ISOtrain) • Experience working in a regulated environment (FDA, OSHA, NRC, etc.) • 1 year experience with Visio and MS Project • eLearning design experience and knowledge of online performance support tools • Ability to work with staff across all levels of an organization • Effective communication and writing skills2012-03-21 18:36:06IrelandAmgenNone14194BRNoneDun Laoghaire, IRL27297538http://www.amgen.jobs/xml/27297538/jobIRLDun LaoghaireAuto req 14198BR Job Posting Title Sr Associate Training & Development Career Category Training Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Under limited supervision, delivers training programs to support business needs. Performs on-the-job training demonstrations and coaching sessions in a learning lab or actual production environment. Conducts classroom training. Works closely with assigned client groups to assess and meet training needs. FUNCTIONS • Responsible for effective delivery of training to client group. Includes classroom, one-on-one, and on-the-job training. Could also ensure effective delivery of eLearning courses. • Works closely with assigned clients, in their work environment, to understand and assess specific training needs. • Communicates client training needs to local training management. • Responsible for delivery of solutions to meet the specific training needs of assigned clients. • Responsible for effective delivery of cGMP and other regulatory training, as required by client group. • Delivers initial and ongoing training for new hires and transfers. Facilitates transition of new hires/transfer-ins from training environment to work environment. • Facilitates the assignment and un-assignment of training courses/modules for staff members. • Provides guidance to client on compliance and regulatory issues. • Participates and /or leads inspections activities. • Coaches and develops SME/ certified trainers within client area to be effective trainers. • Assists in review of human error”-related incidents: determine need for additional or modified training interventions for affected staff. • May provide input into the implementation of corporate core curricula and standard learning processes. • May participate on global training teams as assigned. • May include small scale training design projects to meet local client needs. Basic Qualifications Master’s degree OR Bachelor’s degree & 2 years of of experience directly related to the job OR Associate’s degree & 6 years of experience directly related to the job. Preferred Qualifications • Strong customer service orientation and influencing skills to work directly with client staff and identifying performance needs. • Working knowledge on computer software programs including: Word, Excel, and Power Point. • Works directly with client in delivering training. • Demonstrates understanding of Amgen’s business and culture, and ability to work effectively with staff at all levels • Technical competency commensurate with assigned area(s) of responsibility • Regulatory compliance competency commensurate with assigned area(s) of responsibility Skilled in process modeling and troubleshooting • Basic project management skills • Good interpersonal, group facilitation and presentation skills • Able to accomplish results through own work and through influencing client staff members and management2012-03-21 18:35:48IrelandAmgenNone14198BRNoneDun Laoghaire, IRL27297532http://www.amgen.jobs/xml/27297532/jobUSAField BasedAuto req 14512BR Job Posting Title Sr Biopharmaceutical Rep, Oncology - Salt Lake City, UT Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - Utah Location (City) Field Based Amgen Job Description Territory: (#)17204 Salt Lake City, UT covering SLC, Provo and Ogden, UT As a Senior Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Basic Qualifications Bachelor’s degree & 2 (two)years of directly related experience OR - Associate’s degree & 6 years of directly related experience OR - High school diploma / GED & 8 years of directly related experience Preferred Qualifications Two+ years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries - Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred - Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred - Local Market knowledge - A Bachelor's degree in Life Sciences or Business Administration Core Competencies: - Planning and Organizing Work - Engaging Others Through Effective Communication - Drive to Achieve - Individual Leadership and Impact2012-03-21 18:35:37United StatesAmgenUtah14512BRUTField Based, UT27297523http://www.amgen.jobs/xml/27297523/jobUSAThousand OaksAuto req 13916BR Job Posting Title Global Marketing Sr Mgr, Prolia and Pipeline Assets Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Global Marketing Senior Manager will provide support to the Global Commercial Lead (GCL) supporting Prolia and will ultimately support additional pipeline assets, such as AMG 785 and others. Primary responsibilities include the development and execution of globally integrated plans, with a particular focus on planning and execution of deliverables for the Global Commercial Teams (GCT) and related sub-teams. Projects focused on Prolia and Bone TA strategies are included, e.g., support for annual Global Strategy and Commercial Plans (GSPs and GCPs). This role will report to the TA Head, Bone & Inflammation, Global Marketing. Specific responsibilities include: 1. High quality, integrated Global Commercial plans and marketing projects within programs 2. Communication of deliverables and plan information to key stakeholders 3. Ensuring alignment between Global Commercial and GCT plans 4. Contributing to the development of high performing GCTs and GCT sub-teams including operating reviews 5. Leading and/or participating in special department, cross-functional or team projects 6. Applying best practice project management to Amgen’s Global Marketing processes Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • MBA preferred or equivalent experience and/or training • Eight (8) years experience in the biotechnology, pharmaceutical industry, or other healthcare related field • Marketing, brand management, and/or product launch experience strongly preferred, with associated project management skills • Experience in leading cross-functional teams • Knowledge of bone or women’s health therapeutic areas • Two (2) years of international experience gained within either an affiliate or regional marketing organization • Ability to work cross-culturally2012-03-20 20:22:26United StatesAmgenCalifornia13916BRCAThousand Oaks, CA27271537http://www.amgen.jobs/xml/27271537/jobUSAThousand OaksAuto req 14419BR Job Posting Title Exec Dir Access & Reimbursement Ops Career Category Marketing Employee Subgroup Executive FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Exec Dir Access & Reimbursement Ops is a role responsible for designing, developing and leading the Access and Reimbursement Operations Center of Excellence (CoE) to deliver on corporate and departmental goals. This position provides strategic, operational, and regulatory guidance for development and execution of product/Business Unit access & reimbursement services strategy. Additionally, this position has responsibility for commercial A&R operations platform and outsourced supplier management, including development of critical success factors, supplier metrics and continuous improvement efforts across all brands. Individual will have budget and forecasting responsibility for all commercial call centers. Key components of the role include the following: Access & Reimbursement Operations • Owns commercial Contact Center operations and the execution of brand strategies • Cross-functionally integrates to provide SME input into brand/ Business Unit strategies and operational plans to enable top line growth • Provides leadership across the organization to ensure Contact Centers are optimally utilized and outsourced partners are managed appropriately and cost effectively • Directs the design, implementation, and ongoing improvement of all technology and telephony used by outsourced provider to ensure timely, accurate and cost efficient provision of access and reimbursement services Customer Focus • Leads Amgen commercial teams cross functionally in designing, developing and maintaining customer service standards that improve Amgen’s customer service standards. • Utilize best practices from industry, across Business Units, from R&D, etc. to enhance customer service and contact center program. As a thought leader, this individual will share the customer experience” with other Amgen leaders and lead change that results from enhanced customer knowledge. Management • Will direct A&R operations CoE staff and have dotted line relationships with Business Unit Access Teams in support of strategic plan. • Will own outsourced relationship for commercial Contact Center and will lead operational and annual strategic business reviews. • Will develop a cohesive and effective team to manage outsource partners, integrate with the business units and nurture a collaborative spirit that allows for team and Amgen success. • Develops a working environment that supports all aspects of the Amgen values. Basic Qualifications • Doctorate degree & 6 years of directly related experience, or • Master’s degree & 10 years of directly related experience, or • Bachelor’s degree & 12 years of directly related experience, AND • 6 years of direct managerial and/or leadership experience Preferred Qualifications • MBA or other graduate level degree • In-depth experience leading Contact Centers, preferably in the healthcare industry • In-depth experience in Access and Reimbursement in the biopharmaceutical industry • Experience in managing technical support operations • Experience in managing out sourced providers in a regulated industry • Deep knowledge of current contact handling technology and its deployment • Experience in evaluating and implementing cutting edge technologies within Access and Reimbursement Operations • Successfully led organizational contact center change to adapt to corporate challenges2012-03-20 20:18:35United StatesAmgenCalifornia14419BRCAThousand Oaks, CA27271289http://www.amgen.jobs/xml/27271289/jobUSAThousand OaksAuto req 14399BR Job Posting Title Category Sr Mgr Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Category Senior Manager resides in Global Strategic Sourcing (GSS). Reporting to the GSS Director, the Category Senior Manager will be responsible for business case development, strategic sourcing and ongoing supplier management for assigned categories that support Development. Working within a matrix environment, the Category Senior Manager is responsible for applying in-depth disciplinary knowledge, business acumen and subject matter expertise to deliver strategic sourcing objectives. The Category Sr Manager employs category management, project management and change management techniques to effectively deliver strategic sourcing initiatives. The Category Sr Mgr leads the category management process, which includes conducting business opportunity analysis, make/buy analysis, data analysis, requirements gathering, development and execution of RFx, sourcing strategy development and implementation, contract development, negotiation and management, supplier on-boarding, and implementation and support ongoing supplier governance. Leading project and program teams accountable for successful source and supplier development and management is fundamental to the role. Basic Qualifications -Doctorate degree & 2 years of directly related experience OR -Master’s degree & 6 years of directly related experience OR -Bachelor’s degree & 8 years of directly related experience OR -Associate’s degree & 10 years of directly related experience OR -High school diploma / GED & 12 years of directly related experience Preferred Qualifications -MBA preferred -5+ years of Strategic Sourcing experience -3+ years Biotech/Pharmaceutical experience -7+ years experience in a complex business environment -Certified Purchasing Manager (CPM), Project Management Professional (PMP), and/or Green/Black Belt Six Sigma certification -Category sourcing experience in Research and Development categories such as scientific services, or laboratory support services -General understanding of Biotech/Pharmaceutical practices and standards -In-depth knowledge of the principles, methods and practices as they relate to strategic sourcing, project management and/or change management -Experience contributing to the development of a category strategy with business partners -Ability to translate company goals into category priorities, strategy and direction -Ability to work in a complex business environment -Applies data gathering and analytical skills to drive fact based decision making -Develop innovative and creative outputs based on insightful interpretation and analysis -Ability to define opportunities and risks and facilitate selection of appropriate alternatives -Ability to proactively identify roadblocks and effectively identify and execute solutions -Plan, track and report progress of sourcing related initiatives -Work independently to establish initiative timeline, managing deliverables and ability to appropriately identify and escalate issues when needed -Ability to build productive internal relationships and strategic supplier partnerships -Demonstrated negotiation, conflict resolution and stakeholder management capabilities -Strong oral and written communication skills and excellent organization and planning skills -Demonstrated success with strategically sourcing services that support a biopharma research organization2012-03-20 20:14:07United StatesAmgenCalifornia14399BRCAThousand Oaks, CA27270923http://www.amgen.jobs/xml/27270923/jobUSAThousand OaksAuto req 14408BR Job Posting Title Reimbursement Director, Global Value and Access Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Participate as a member of Amgen's Global Pricing and Payer Planning Team. This team is responsible for strategic planning to support value and access for all Amgen molecules in development, beginning in Phase I-II and extending throughout commercialization across the Amgen portfolio. This includes lifecycle planning and access support for our inline molecules. Additionally, the team is responsible for global strategic pricing, including recommendations for global price bands and launch sequence. Each global payer plan integrates coverage and reimbursement, pricing, value evidence, and policy into the development of a strategic plan that supports the overarching commercial objectives and links to the clinical attributes of the molecule. This plan elucidates and communicates the strategies and tactics to secure and maintain access throughout the lifecycle of a specific molecule. Each Director will serve as the Global Payer Leader and represent payer needs on the multi-disciplinary Product Strategy Team for one or more molecules. He/she will also lead Global Payer Team(s) that support the payer planning process, including the situation analysis and the creation of global payer plans. This will include the development of new plans as well as the update of prior plans to reflect changes in product data and/or the global payer environment. Each member of the team must work collaboratively across functions to ensure a comprehensive view of his/her assigned products and create and maintain strong collaborative working relationships with key stakeholders. These stakeholders include colleagues in marketing, development, health economics, regulatory, operations, and government affairs.The individual must also oversee and conduct relevant payer/pricing research and integrate clinical, market, and payer information to develop and communicate the plan. In addition to product-specific responsibilities, each member of the team also participates in one or more cross-portfolio projects each year. These projects either serve to advance the team’s knowledge of and readiness for the global payer environment, support specific market or product assessments, or attempt to influence payer policy development. Examples include: Payer assessments to support potential mergers/acquisitions, payer landscape in emerging markets, exploration of new payer trends (e.g., bundling), or development of a policy white paper to shape external price and reimbursement policies in the global arena. Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience Preferred Qualifications • Strong understanding of payer environment, both within the US and globally, including coverage and reimbursement, pricing, value drivers, formulary management, health technologies assessment, health policy • Ability to conduct situation analysis of external pricing and reimbursement environment and synthesize relevant information to develop strategic plans • Ability to develop and test value messages and value evidence with payers in order to determine the most compelling way in which to demonstrate and communicate product value to payers • Ability to conduct qualitative and quantitative pricing studies and to formulate price policy recommendations • Ability to formulate health policy strategy and implement these strategies to shape external pricing and reimbursement environment • Ability to review clinical and health economic literature, including disease state information, clinical trial design and results, and pharmacoeconomic studies, in order to understand implications for value to payers • Excellent communication skills, including interpersonal skills to foster collaboration and succeed in a highly matrixed environment; strong oral/written presentation skills • Demonstrated success as a team leader with strong team management skills • Clinical degree (PharmD, MD, RN) and experience strongly preferred • Direct payer experience and/or experience in product commercialization desirable • Strategic planning and health policy experience strongly preferred • Pharmaceutical pricing experience strongly preferred • Previous international (ex-US) assignment desirable2012-03-18 20:10:24United StatesAmgenCalifornia14408BRCAThousand Oaks, CA27229088http://www.amgen.jobs/xml/27229088/jobGRCAthensAuto req 14312BR Job Posting Title Product Manager Oncology Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) Greece Location (City) Athens Amgen Job Description Reporting to the Sr Mgr Business Unit Oncology, the person will have the purpose of: • Maximises the brand potential at national level • Executes Country Operating Plan • Delivers branding campaign in line with international guidance Responsibilities: • Drives motivation of sales force towards brand aspiration (cycle and launch meetings) • Develops and implements Country Brand Plan in full congruence with International Brand Plan • Designs and executes promotional activities (detail aids, message scripts, advertising, congresses, etc.) in line with international branding and key messages • Develops LRP with Business Planner • Proposes national sales target and achieves agreement with Business Unit Leader and Sales/District Managers • Partners with international PM • Translates/implements international brand campaign locally • Analyses market research and develops POA • Coordinates competitive intelligence and drives competitive action plans • Partners with the Medical Affairs Manager to optimize the brand performance (goals of clinical trials, KOL development, etc.) • Agrees with other PM in Franchise Team on joint projects • Recruits and manages external vendors • Identifies business opportunities and develops business cases Basic Qualifications • Academic education or experience from similar positions and therapeutic area • Minimum 3 years of experience in industry • Minimum 2 years of experience as a Product Manager • Fluency in English, both oral and written communications • Financial and budgeting skills and experience • Documented track record of product launch • Computer skills (MS Office programs) • Tenure at last two jobs for at least 2 years each Preferred Qualifications Preferred Requirements: • Minimum 2 years in a large pharmaceutical company • 1 to 3 years as a Pharmaceutical Sales Representative • Minimum 2 years of experience in a US pharmaceutical company • Documented experience in Franchise area (e.g., Oncology, Nephrology, etc.) • Documented success in gaining or maintaining market leadership position2012-03-16 20:16:58GreeceAmgenNone14312BRNoneAthens, GRC27211281http://www.amgen.jobs/xml/27211281/jobUSAThousand OaksAuto req 14115BR Job Posting Title Principal Scientist - Chemicals, Product and Process Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position is for a subject matter expert within the Product and Process Engineering Organization responsible for providing scientific and technical leadership and strategic direction to the evaluation of designated raw materials, in this case chemicals and excipients used in biopharmaceutical manufacture, and their potential impact on product quality and process performance. Extensive knowledge of the manufacturing processes of raw materials, their usage, regulatory/compendial requirements, practices, physical/chemical properties and compatibility with proteins, and risks associated with the raw materials for pharmaceutical and biological products is desirable, along with the ability to assess the impact of changes in materials or manufacturing processes. This individual will be responsible for assessing supplier capabilities, technical competencies and understanding of the needs of biopharmaceutical manufacturers along with other team members. The successful candidate will support or lead cross-functional teams of experienced scientists and engineers through project challenges and mentor them in the selection of the most appropriate materials and technologies. The candidate will actively chart the course and translate business strategies into challenging, actionable objectives and plans, and will apply meaningful metrics for projects, personnel and other resources. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • PhD in chemistry, or MS in chemistry with multiple years in the manufacture of pharmaceutical grade materials • Ten years relevant work experience in pharmaceutical/biopharmaceutical applications • Knowledge of Regulatory Filings and the drug development process • Familiarity with aspects of the use of materials in biopharmaceutical applications, from sourcing, developing collaborative relationships between supplier and user, dealing with change notifications and non-conformance investigations. • Knowledge of state of the art technologies and emerging scientific and regulatory directions for testing and securing quality and minimizing variability. • Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects. • Should be recognized in the scientific community and supplier base through a sustained record of publications and patents. • Should have strong communication skills, both written and oral. • Ability to network and build solid working relationships within and across departments, with diverse and remote staff and with external collaborators from key suppliers. • Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans. • Team leadership, management, and facilitation skills are required. • Ability to travel (approx 30%) to other Amgen sites and/or support supplier technical assessments or audits at short notice domestically and overseas.2012-03-16 02:42:34United StatesAmgenCalifornia14115BRCAThousand Oaks, CA27183556http://www.amgen.jobs/xml/27183556/jobUSANoneAuto req 14334BR Job Posting Title Sr Regional Medical Liaison Career Category Medical Affairs Employee Subgroup Salaried FT Country (State/Region) United States - Field Based Location (City) Field Based Amgen Job Description This position is a field-based position for the Inflammation Therapeutic Area Regional Medical Liaison (RML) team within the Scientific Affairs organization. The territory will cover Washington, D.C., Baltimore, and the greater Washington area in Maryland (including Bethesda, Gaithersburg, Frederick, Cumberland, Annapolis, and portions of Eastern Shore). The Senior Regional Medical Liaison (Sr RML) will interact with healthcare decision makers, including investigators, to communicate and advance the scientific platform as aligned with Amgen's corporate goals and objectives. The Sr RML is an integral position in assuring accuracy in communication of our science and products across the medical community. The successful Sr RML will communicate complex cutting-edge scientific information and research concepts to healthcare decision makers including, but not limited to, those at Centers of Education and Research. In addition, the Sr RML will provide feedback based on field interactions and scientific support consistent with Amgen goals. The Sr RML will: • Interact with healthcare thought leaders to communicate and advance the scientific platform, as aligned with Amgen’s corporate goals and objectives • Communicate complex cutting edge, scientific information and research concepts to healthcare decision makers, including but not limited to, those at Academic Medical Centers • Support Amgen sponsored research • Provide feedback based on field interactions with healthcare opinion leaders • Foster scientific relationships between Amgen and Fellows-in-training • Lead and/or participate on committees or project teams that support RML strategies and tactics as delegated by RML leadership • Mentor RML’s as designated by RML leadership • Seek out opportunities to support the RML value proposition and achieve results and set an example for others to follow by consistently demonstrating Amgen Values and Leadership Attributes. • Demonstrate tact and organizational savvy when communicating and interacting with others. • Remain agile regarding assignment changes based on research priorities and needs at the direction of RML leadership The Sr RML will model openness and innovation through words, actions, and decisions. Amgen RMLs share learning including entrepreneurial and innovative ideas with others and hold self accountable for performance, as well as encouraging others to achieve and be accountable for performance. Basic Qualifications Doctorate degree & 2 years of directly related experience Preferred Qualifications Pharm.D., Ph.D., or M.D. (Other Doctoral Degrees considered) - 7 or more years of experience in a medically related field, including 1 or more years focused on clinical practice, clinical research, or medical research. Experience in a medically related field can include post doctoral training (i.e., residencies and/or fellowships). - 3 + years in a medical science liaison role in a biotech or pharmaceutical company -experience in Scientific Affairs or Medical Affairs at a biotech or pharmaceutical company -Inflammation therapeutic expertise area knowledge2012-03-16 02:42:29United StatesAmgenNone14334BRNoneVirtual, USA27183553http://www.amgen.jobs/xml/27183553/jobUSAThousand OaksAuto req 14239BR Job Posting Title Research Operations Manager - Amgen Tissue Bank Career Category Preclinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the globe, Amgen fosters an inclusive environment of diverse, committed and highly accomplished people. People who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen Tissue Bank (ATB) is seeking a highly motivated individual to join our multidisciplinary team in Thousand Oaks, CA. Amgen Tissue Bank is a biobank that procures and maintains a collection of tissues for use by Amgen researchers. The individual in this role will provide expert, project-specific guidance to scientific staff, design and manage complex sample procurement strategies involving Amgen staff, external vendors and service providers, maintain and manage specimens, data and financial records, prepare detailed reports, use analytical skills to assess accuracy of detailed information and ensure compliance with regulations. The successful individual will work independently under minimal direction, and collaborate with various teams within Amgen, Amgen vendors, and Service Providers. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Degree in allied health, biological, or life sciences • Familiarity with medical and scientific terminology • Possess initiative, independence, flexibility, willingness to learn, ability to embrace challenges, and a strong commitment to quality • Strong interpersonal, verbal, and written skills essential • Detail oriented, proactive, ability to work independently and in teams • Proficiency with Microsoft Excel, Word, Sharepoint, and document management applications (Documentum, EDM) • Familiarity with databases and data analysis software (LIMS, Access, SigmaPlot, SpotFire, etc.) • Strong organizational, time, and project management skills, ability to prioritize, plan and facilitate meetings, identify and track progress on action items • Previous knowledge or experience in a histology/pathology/medical technology laboratory environment desirable • Familiarity with GxP regulations a plus2012-03-16 02:41:54United StatesAmgenCalifornia14239BRCAThousand Oaks, CA27183540http://www.amgen.jobs/xml/27183540/jobUSAThousand OaksAuto req 14338BR Job Posting Title Director of Enterprise IS Technology Services Design and Engineering Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Director of Enterprise IS Technology Services Design & Engineering is responsible for the development, delivery, and life cycle of Amgen IS Infrastructure technologies. Leading a team of multi-disciplinary experts and providing Engineering direction across the organization, this position will deliver timely designs and implementations from the existing technology portfolio, create new solutions, and maintain the technology portfolio life cycle. Job Responsibilities • Be accountable for developing, delivering and maintaining Enterprise Information Systems Technology Services (EISTS) portfolio consisting of an integrated set of designs, detailed specifications, roadmaps and program delivery for solutions delivered by EISTS, which includes Application Hosting, Networks, End User Technology and Integrated Services. • Ensure the relevance and completeness of designs and delivered solutions to EISTS service owners. • Accountable to ensure IS projects leverage and maximize value Engineered solutions from the portfolio technologies through strong collaboration within EISTS and across IS. • Lead the introduction of new EISTS Technologies into the portfolio to enable business value driven innovation while maximizing organizational effectiveness and efficiency. • Maintain the technology portfolio life cycle for EISTS, including driving the retirement of obsolete or declining technologies and delivery of successor technologies to enable efficient service provision and minimize risks. • Enhance cross IS Technology governance, establish and lead new engagements at both the strategic and the project levels to define and implement a shared technical vision and lifecycle roadmap. Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Master’s degree • Bachelor’s Degree in Information Systems, Computer Science, or Electronics. • 15 + years experience working within information systems • 8+ years experience supervising cross-technology engineering staff on large and small IS infrastructure technology delivery • Meaningful technical design engineering leadership experience with global companies using Information Technology and Services in regulated environments. Additional experience with technology supply companies a plus. • 5+ years biotechnology or pharmaceutical experience are a plus. • Strong leadership and communication skills to convince all stakeholders on programs and portfolio investments. • The ability to function in multiple roles based on project demands. • Strategic leadership experience and ability to facilitate alignment and investment across multiple geographies, functions, and disciplines. • Excellent oral, written and interpersonal communication skills This position requires a senior and credible IS Infrastructure technology design and delivery leader, with broad experience and demonstrated success leading an Infrastructure engineering design and delivery team. It requires also a passion for Information Technology and engineering, in depth understanding of Infrastructure technologies, of technology integration, and of industry practices. Learning agility, technical excellence, technical management, discipline and the capability to engage and collaborate across the IS Function in a relationship based organization to drive change and continuous improvement at all levels are essential attributes. This individual will leverage his/her long experience in designing and delivering global information infrastructure systems in a regulated environment for the Enterprise and a diverse range of specialized business needs and partner with business IS and other Enterprise shared services.2012-03-14 18:24:07United StatesAmgenCalifornia14338BRCAThousand Oaks, CA27135934http://www.amgen.jobs/xml/27135934/jobUSAThousand OaksAuto req 14290BR Job Posting Title CDM Systems Manager Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description THIS ROLE CAN BE BASED AT AMGEN’S THOUSAND OAKS, CA OR SOUTH SAN FRANCISCO SITE Serve as primary point-of-contact to coordinate and lead comprehensive and holistic Clinical Data Management system services to Data Management Therapeutic teams. The Manager of Client System Services – CDM Systems Interface (CSI) role will ensure the proper, timely, and successful setup and implementation of clinical data management services during study startup, study maintenance, and study closeout for individual study teams. The CSI will ensure the most effective use, implementation, and observance of systems and data standardization, and status of CDM System services including but not limited to EDC, clinical trial database programming deliverables, including database, edit check, custom report programming, CDM Systems lab administration, CDM SAS programming deliverables, including data transfer plans, electronic data load, lab range entry, lab data review, IVRS, IWT, and SAS macros and other clinical data management activities according to study startup timelines in a regulatory compliant manner. This position is expected to partner effectively with other CDM System team members to seamlessly ensure high quality deliverables serving as the primary point of contact as a program management function to the systems and technology setup and operations supporting study management activities. The CSI is expected to ensure and support continuous global operations of Amgen’s Data Management operations and systems and work collaboratively with the Thousand Oaks and UK based CDM teams and stakeholders enabling operational effectiveness and utilization. Other responsibilities include: • Mentor and support junior staff • Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines. • Procurement and program management of resources, timeline, and services from both internal and external service providers • Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology • Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers • Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives • Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished • Develop strong relationship with external providers (such as FSP and Vendor Provider) and utilize strong negotiation skills to ensure a delivery of CDM Systems deliverables Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • 3+ or more years of experience in a client facing technical role within clinical data management, clinical development, or IS/IT • Successful delivery and track record performing and leading a team in a customer facing mission and representing and ensuring enterprise class technical service delivery • Previous experience working in a global environment • Previous Data Manager in clinical development setting or study team related experience • Superior partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements • Medidata RAVE, Oracle Siebel eClinical, or Oracle Remote Data Capture hands on operational and system knowledge desirable • Work experience implementing other clinical technologies including but not limited to IVRS, IWT, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred • Experience and ability creating and effectively presenting concepts and materials to senior and executive levels • Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary • Knowledge of ITIL v3 and basic Industry IS best practices • Candidates should demonstrate excellent project management and broad technical understanding, attention to detail, and excellent communication and documentation skills • Excellent time management and organization skills required • Must have sound problem resolution, judgment, and decision-making abilities • Must be able to work well in a global team-based matrix environment with minimal supervision • Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable2012-03-14 03:14:47United StatesAmgenCalifornia14290BRCAThousand Oaks, CA27126977http://www.amgen.jobs/xml/27126977/jobUSAThousand OaksAuto req 10371BR Job Posting Title Principal Engineer - Primary Container Manufacturing Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Primary Container Manufacturing and Device Mechanical Engineer The successful candidate for this position is required to provide hands-on technical leadership to primary container mechanical design. Job responsibilities will be primarily focused on; 1. Leading the characterization of mechanical interfaces / interactions of primary containers with equipment and devices, 2. Development of test methods for mechanical characteristics, 3. Produce models and drawings using Solid Works, 4. Perform basic engineering analysis such as tolerance stack up and FMEAs, 5. Develop and leverage a basic working knowledge of relevant manufacturing processes to apply Design for Manufacturability 6. Develop and execute test protocols and publish associated reports 7. Support the maintenance and creation of Design History Files in accordance with established Company's Product Development Process This role will be required to collaborate extensively with external suppliers and Drug Delivery/Device teams This position may have supervisory opportunities and responsibilities for technical personnel. This position will report to the leader of the Vendor Process Design and Control group and will be located in Thousand Oaks California. Some domestic and international travel will be required. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Ph. D. in Materials Science or Mechanical Engineering with 5 or more years of experience in the Pharmaceutical/Biotechnology industry, Medical Device industry. • Experience to include materials processing, mechanical design, physical characterization of glass and plastic systems, statistical process control (SPC), and design of experiments (DOE). • Strong problem solving, trouble shooting, and communication skills are preferred. • Ability to coach junior engineers, participate in global cross-functional teams, and work effectively in a highly matrix environment. • Familiarity with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic filling processing. • Experience in managing multiple projects simultaneously, strategically prioritizing activities, and leading cross functional teams.2012-03-14 03:14:34United StatesAmgenCalifornia10371BRCAThousand Oaks, CA27126960http://www.amgen.jobs/xml/27126960/jobUSAThousand OaksAuto req 14269BR Job Posting Title Director, Design Assurance - Drug Delivery Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The successful Director of Design Assurance (DA) will lead and build a dynamic team that supports all new product development across the organization. In this high profile assignment you will lead a team of direct reports (Quality Engineers) responsible for design assurance for new and existing technology. This team are responsible for accurate, independent evaluation of Design History File documentation, Design intent and Design Quality. A key driver of success in this role is to translate design requirements into processes that ensure quality attributes in the final design are maintained and are practical for manufacturing. The candidate will work closely with R&D to facilitate the development of innovative technology in a timely manner. Programs are focused on early development through transition to manufacturing with some sustaining work and will include risk management, reliability and failure analysis, and quality planning. Other responsibilities include independently determining appropriate test, verification and validation parameters to ensure components and products meet specifications requirements. Key Responsibilities: • Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of best practice engineering techniques, testing procedures and criteria. • Ensure team works closely with product development engineering and the client team to establish the system design specifications and product requirements. • Ensure team works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan in conformance with the system design specification and sound testing principles. • Plans, coordinates and executes design verification testing to directly support the master verification plan, including any additional activities such as HALT/HASS and IEC 60601-1-x testing and other standardized test methods. • Participates with the engineering team to establish and review the design FMEA, FMECA and other risk related activities (ISO14971). • Facilitate the achievement of business goals for device reliability, quality, customer satisfaction, cost and safety by identification, development, and accomplishment of key initiatives supporting the business objectives and operational goals for device reliability quality improvements, customer satisfaction, supplier and component initiatives, and safety. • Product reliability design improvements by ongoing research, design and further development of existing products to continuously improve device reliability, quality, and customer satisfaction. Validated product changes with completed documentation that meets or exceeds established guidelines, plus well-documented research/analyses that support decisions and conclusions. Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience AND • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Advanced degree in an Engineering discipline, or other Engineering/Life Sciences related discipline and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments. • 4 years of engineering managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources and have lead the commercial launch of a medical device. • Certified Quality Assurance professional with 3+ years of direct experience in Quality. • CQA, CQM, Six Sigma Black Belt preferred. • ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or Certified Auditor credentials (e.g., ISO 13485). • Lean and or Six Sigma Certification. • Previous experience in DA engineering and commercialization process with drug delivery devices and combination drug/device products is desired • DA experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal). • Minimum of 8+ years experience working in the development of electro-mechanical systems design, verification and validation. • Microcontroller based firmware experience, Real time OS and SW design test, verification and validation experience (unit, static, dynamic and Cyclomatic complexity analysis). • Ability to write software test cases, protocols, and reports. • Experience with circuit design, analysis, troubleshooting, and testing. • Familiar with PCB/PCA assembly and fabrication. • Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools • Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected. • Experience with complex, cross-functional development projects. • Experience working with and leading cross-cultural teams. • Proven ability to apply situational leadership concepts across various intra and inter-departmental matters. • Demonstrated time management, decision making, presentation and organization skills. • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines.2012-03-14 03:14:28United StatesAmgenCalifornia14269BRCAThousand Oaks, CA27126959http://www.amgen.jobs/xml/27126959/jobUSASeattleAuto req 14024BR Job Posting Title Post Doctoral Fellow - Functional Biocharacterization Career Category Process Development Employee Subgroup Salaried FT Country (State/Region) United States - Washington Location (City) Seattle Amgen Job Description We are seeking a highly motivated, creative postdoctoral fellow to investigate and develop approaches for assessing Fc-mediated effector functions of therapeutic monoclonal antibodies. The project will require extensive cellular and molecular biology including the development and use of in vitro cell-based assay systems and in vivo animal models. Basic Qualifications This position requires a Ph.D. in immunology, cell biology, molecular biology, or related field. Ph.D. must be awarded before the start of the post doctoral position. Preferred Qualifications The candidate must have excellent cell culture, cell biology, molecular biology, and analytical skills as well as a good understanding of antibody Fc effector functions. The candidate must be highly self-motivated, have excellent communication skills (oral and written), and the ability to work independently and in a multidisciplinary team environment.2012-03-14 03:14:26United StatesAmgenWashington14024BRWASeattle, WA27126957http://www.amgen.jobs/xml/27126957/jobUSAThousand OaksAuto req 14174BR Job Posting Title Human Resources Sr Mgr, Project Management, Mergers and Acquisitions Career Category Human Resources Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This HR Senior Manager position is within Amgen's HR Program Management Office, responsible for leading high priority, high impact projects and initiatives that span across Amgen HR and in many cases across Amgen corporate-wide. Projects typically affect multiple functions, locations and countries requiring excellent collaboration skills, clear decision-making capabilities and business maturity. The position provides project management leadership to high priority initiatives which may include but not be limited to: • Domestic and International Mergers & Acquisitions. Activities include: management of all phases of M&A from due diligence/deal valuation through post-merger integration. Tasks typically include identification of resources to support HR activities, leadership and coordination of HR deal teams and integration plans; creation and management of HR deal budgets; coordination of communications with non-HR functions; and serving as primary liaison to Corporate Development, Legal and Business leadership. May require international business travel and/or short-term assignment in international locations. • Select HR portfolio projects that further Amgen’s HR strategy (e.g., project managing selection and implementation of new Talent Management tool and related processes). Activities typically include: creation and tracking of project plans and timelines, identification and resolution of team-related cross-functional issues, working with leaders to identify and focus teams on critical path activities, and developing and delivering status reports to senior leadership. Some travel will be required for this role - approximately 10-20%. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • MBA or other advanced degree • Demonstrated comfort with ambiguity and organizational change is critical for success in this position • Strong knowledge of, and experience in, breadth of HR roles, both COE and HRBP • Previous experience with M&A/integration management • Demonstrated project leadership skills, including ability to manage diverse cross-functional teams • Outstanding written/oral communication and presentation skills at senior executive levels • Ability to understand, balance, and articulate both tactical and strategic planning issues • Strong quantitative, analytical (technical and business), and problem solving skills • Persistent, tactful, and persuasive team and project leadership, including conflict resolution and negotiation skills • Ability to prioritize across multiple projects and handle diverse assignments simultaneously2012-03-12 00:23:55United StatesAmgenCalifornia14174BRCAThousand Oaks, CA27064044http://www.amgen.jobs/xml/27064044/jobUSAThousand OaksAuto req 14278BR Job Posting Title Principal IS Business System Analyst (Enterprise Application Services Project Portfolio Senior Manager) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Job Summary The Enterprise Applications Services (EAS) Project Portfolio Senior Manager is responsible for providing oversight and coordination for all projects across EAS. The Senior Manager works with the EAS SLT to ensure that the EAS project portfolio aligns with business and IS strategies and priorities to deliver maximum value. The position combines both strategic and advisory elements, as well as hands-on management and analysis activities. Job Responsibilities: • Collaborates with the EAS leadership, CFIS, project managers and system owners to develop and manage project and program budgeting, cost estimation approaches and resource allocation for EAS. • Collaborates with EAS leadership, EAS project managers, Enterprise-wide Portfolio Management group and other portfolio governing bodies by participating in and supporting the latest estimate annual budgeting process and other portfolio related activities. • Works with EAS leadership and key stakeholders to prioritize EAS projects based on changing functional needs, resource capacity, and risk exposure. • Works with EAS leadership and project managers to develop resourcing strategies to ensure optimum support for projects and for the day to day operational activities. • Communicates status of overall EAS portfolio and facilitates communication of projects to EAS leadership and other key stakeholders. • Delivers portfolio level planning and reporting, while ensuring projects are aligned with the business and IS strategies. • Maintains overall project budgetary oversight responsibility for EAS. • Understands and communicates changes to budget approval and monitoring processes. As required, provides training to EAS staff on budget processes. • Communicates and monitors due dates for portfolio related deliverables. • Develops improvement techniques within portfolio management to achieve process efficiencies, innovation, and operational excellence. • Manages the EAS portfolio using Amgen’s portfolio management tool. Supports PMs with the creation and editing of projects in the tool. Completes project change and close out notifications. • Facilitates the project initiation and approval and supports project managers through the capital funding process. • Supports individual projects by providing advice and guidance regarding project governance, management and benefits realization. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Master’s degree • Bachelor’s Degree in Engineering, Information Systems, Computer Science, Business, Finance or the Life Sciences. • Strong financial background • 5 + years experience working within information systems and/or project management • Strong oral, written and interpersonal communication skills • Knowledge of Amgen Business and IS practices as well as previous experience with global projects • Sound experience managing of IT, business analysis or business change • IT Financial management expertise including competency in business analysis and business case development. • Proven influencer and communicator with stakeholders at all levels. • Delivering results: ability to plan and organize self and work in order to achieve objectives and targets. Is determined to deliver outcomes and is able to overcome obstacles in order to move forward. Accountable for the delivery of outcomes, strives to meet and exceed the expectations of customers. • Influencing and negotiating: has the confidence and gravitas to influence and challenge at executive level. • Working with others: ability to work effectively with colleagues, managers, suppliers and stakeholders. Understands the importance of developing effective partnership relationships with key suppliers.2012-03-10 18:08:23United StatesAmgenCalifornia14278BRCAThousand Oaks, CA27057976http://www.amgen.jobs/xml/27057976/jobUSASouth San FranciscoAuto req 14287BR Job Posting Title Principal Scientist Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Amgen Job Description Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the globe, Amgen fosters an inclusive environment of diverse, committed and highly accomplished people. People who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. The successful employee will provide scientific and managerial leadership to a group of scientists/associates as well as manage collaborations for the Genome Analysis Unit (GAU), a strategic innovation group within Discovery Research at Amgen. The group is based in 3 separate sites and consists of 31 staff members. The group operates semi-autonomously but also collaboratively across all Research to deliver large molecule therapeutics for oncology, metabolic disorders, and inflammation, as well as to develop innovative platform technologies that enable drug discovery. The successful employee is expected to be knowledgeable in cancer biology and/or other areas of disease biology that are/is of interest to Amgen Research. The employee is expected to partner with the leads of the computational biology group within the GAU to interpret complex data analysis, to decipher and develop hyphotheses for new therapeutic targets, and design in vitro and in vivo studies to characterize impact of target modulation, and manage a wide range of interdepartmental project collaborations. The employee must possess industry experience, experience in staff management, ability to harmonize between different teams within Discovery Research, as well as with external groups including Molecular Sciences, Clinical Immunology, and Research Imaging Sciences for effective collaboration in a matrixed environment. The employee will be expected to contribute to strategic, tactical, and operational discussions for the GAU. Knowledge of Amgen Research environment is a plus. Basic Qualifications • Doctorate degree & 5 years of scientific experience OR • Master’s degree & 12 years of scientific experience OR • Bachelor’s degree & 15 years of scientific experience Preferred Qualifications • Doctorate degree in life sciences and 5 or more years of directly related experience • 5+ years of experience in industry with management responsibilities, demonstrated ability to effectively interface with leaders across an organization and manage collaborations, project team leadership • Relevant knowledge of the development of protein therapeutics, molecular and cell biology, genetics, cancer biology, next-gen-sequencing, strong written and verbal communication2012-03-09 18:35:23United StatesAmgenCalifornia14287BRCASouth San Francisco, CA27037842http://www.amgen.jobs/xml/27037842/jobUSAThousand OaksAuto req 14250BR Job Posting Title Category Sr Mgr Career Category Procurement Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Category Senior Manager resides in Global Strategic Sourcing (GSS). Reporting to the GSS Director, the Category Senior Manager will be responsible for business case development, strategic sourcing and ongoing supplier management for assigned scientific and/or laboratory services categories that support Amgen’s Discovery Research and Translational Sciences functions. Working within a matrix environment, the Category Senior Manager is responsible for applying in-depth disciplinary knowledge, business acumen and subject matter expertise to deliver strategic sourcing objectives. The Category Sr Manager employs category management, project management and change management techniques to effectively deliver strategic sourcing initiatives. The Category Sr Mgr leads the category management process, which includes conducting business opportunity analysis, make/buy analysis, data analysis, requirements gathering, development and execution of RFx, sourcing strategy development and implementation, contract development, negotiation and management, supplier on-boarding, and implementation and support ongoing supplier governance. Leading project and program teams accountable for successful source and supplier development and management is fundamental to the role. Basic Qualifications Doctorate degree & 2 years of directly related experience OR -Master’s degree & 6 years of directly related experience OR -Bachelor’s degree & 8 years of directly related experience OR -Associate’s degree & 10 years of directly related experience OR -High school diploma / GED & 12 years of directly related experience Preferred Qualifications MBA preferred 5+ years of Strategic Sourcing experience 3+ years Biotech/Pharmaceutical experience 7+ years experience in a complex business environment Certified Purchasing Manager (CPM), Project Management Professional (PMP), and/or Green/Black Belt Six Sigma certification Category sourcing experience in Research and Development categories such as scientific services, or laboratory support services General understanding of Biotech/Pharmaceutical practices and standards In-depth knowledge of the principles, methods and practices as they relate to strategic sourcing, project management and/or change management Experience contributing to the development of a category strategy with business partners Ability to translate company goals into category priorities, strategy and direction Ability to work in a complex business environment Applies data gathering and analytical skills to drive fact based decision making Develop innovative and creative outputs based on insightful interpretation and analysis Ability to define opportunities and risks and facilitate selection of appropriate alternatives Ability to proactively identify roadblocks and effectively identify and execute solutions Plan, track and report progress of sourcing related initiatives Work independently to establish initiative timeline, managing deliverables and ability to appropriately identify and escalate issues when needed Ability to build productive internal relationships and strategic supplier partnerships Demonstrated negotiation, conflict resolution and stakeholder management capabilities Strong oral and written communication skills and excellent organization and planning skills2012-03-08 19:15:42United StatesAmgenCalifornia14250BRCAThousand Oaks, CA27012353http://www.amgen.jobs/xml/27012353/jobUSAThousand OaksAuto req 14249BR Job Posting Title Sr Project Manager - Manufacturing of the Future (MoF) Engineering Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The MoF Engineering Project Manager is responsible for coordinating elements of MoF engineering design and leading multiple MoF engineering work streams. The engineer shall provide direction to the operations team on the engineering elements needed to ensure all projects and facilities under the MoF program become qualified and operational within specified timeframe and budgets. This role will require up to 50% travel and is located in Thousand Oaks, CA. Key responsibilities include, but are not limited to, the following: Technical / Design Leadership: Provide leadership to align technical issues across all MoF capital projects and interface with the equipment team leads. Ensure projects align with Amgen’s technical business processes. Planning: Interface with equipment and project teams to ensure there is alignment of key program milestones and articulate the impact of changes in projects or program on the individual schedules. Develop specific action plans with deliverables and resources needed to deliver elements such as program maintenance of the new facility and equipment, all Maximo elements, calibration, etc. Construction: Oversight of technical issues that arise during construction, ability to understand programmatic aspects of decisions made and skills to understand when necessary to escalate issues to the leadership. Commissioning: Ensure proper commissioning programs are developed and used, and qualification processes are implemented. Maintenance: Develop maintenance program with operations team, interfacing with project teams, leadership team, Engineering Technical Authority, and receiving site. Monitoring progress, resolving technical conflicts. Basic Qualifications Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications • Background in drug substance manufacturing facilities, well rounded experience in design, project engineering, process engineering, qualification, and maintenance • Masters Degree in Engineering, Chemical, BioChemical, Mechanical • Professional registration, such as a Professional Engineer license • 10 years engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in Upstream Processes, Downstream Processes, and CIP/SIP including 5 years experience in executing engineering projects (cross functional team managing departmental or functional level projects: approving resources, assigning tasks, presenting milestones, deciding cost/benefit analysis) • 5 years experience in engineering in biotech/pharmaceutical industry in manufacturing support (quality, process development, manufacturing, clinical manufacturing) • Strong communication, relationship building, leadership and mentoring skills • Proven ability to manage and deliver results in a highly fluid, interactive matrix environment2012-03-08 19:15:41United StatesAmgenCalifornia14249BRCAThousand Oaks, CA27012351http://www.amgen.jobs/xml/27012351/jobUSAThousand OaksAuto req 14225BR Job Posting Title Sr Project Manager - Manufacturing of the Future (MoF) Process Development Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Senior Project Manager, Manufacturing of the Future (MoF) Process Development is responsible for establishing and leading cross functional strategic initiatives in support of the MoF operating platform. This role will focus on developing MoF technology transfer methodologies, MoF operational philosophies, and representing the MoF leadership team on interactions with impacted pipeline process teams. This role will require up to 50% travel and is located in Thousand Oaks, CA. Key responsibilities include, but are not limited to, the following: • Partner with process teams to understand / manage risks to program timelines and assess impact to proposed MoF platform deviations • Develop structure and methodologies for transferring new operational philosophies and technologies into the MoF network • Lead the implementation of process analytical technologies (PAT) from analytical sciences into MoF production facilities • Represent the MoF team in the establishment and implementation of MoF platform technologies and processes • Develop Process Development staffing plan for future state MoF operations • Management of multi-disciplinary projects with the development of clearly articulated scope and quantifiable business benefits • Develop specific action plans with deliverables and resources needed to implement new technologies and address gaps between proposed MoF philosophies and existing operating standards or established operational norms Basic Qualifications • Doctorate degree and 2 years of directly related experience OR • Master’s degree and 6 years of directly related experience OR • Bachelor’s degree and 8 years of directly related experience OR • Associate’s degree and 10 years of directly related experience OR • High school diploma / GED and 12 years of directly related experience Preferred Qualifications • Background in drug substance manufacturing facilities, well rounded experience in design, project engineering, process engineering, qualification, and maintenance • 5 years experience associated to inter site product transfers, new product introduction, or technology development • Strong communication, relationship building, leadership and mentoring skills • Proven ability to manage and deliver results in a highly fluid, interactive matrix environment • Candidate should have strong leadership, communication, and interpersonal skills with the ability to approach issues from a strategic perspective and stay focused on the big picture. This includes the ability to develop and translate strategy into actionable objectives to effectively drive the project team, advocate client positions throughout the life cycle of the project, and make value-based decisions. • Applicants should be proficient in project management tools and have experience communicating and presenting ideas to all levels of staff and management2012-03-08 19:15:02United StatesAmgenCalifornia14225BRCAThousand Oaks, CA27012312http://www.amgen.jobs/xml/27012312/jobUSAThousand OaksAuto req 14193BR Job Posting Title Category Sr Mgr Career Category Procurement Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Category Senior Manager resides in Global Strategic Sourcing (GSS). Reporting to the GSS Director, the Category Senior Manager will be responsible for business case development, strategic sourcing and ongoing supplier management for assigned scientific and/or laboratory services categories that support Amgen’s Discovery Research and Translational Sciences functions. Working within a matrix environment, the Category Senior Manager is responsible for applying in-depth disciplinary knowledge, business acumen and subject matter expertise to deliver strategic sourcing objectives. The Category Sr Manager employs category management, project management and change management techniques to effectively deliver strategic sourcing initiatives. The Category Sr Mgr leads the category management process, which includes conducting business opportunity analysis, make/buy analysis, data analysis, requirements gathering, development and execution of RFx, sourcing strategy development and implementation, contract development, negotiation and management, supplier on-boarding, and implementation and support ongoing supplier governance. Leading project and program teams accountable for successful source and supplier development and management is fundamental to the role. Basic Qualifications -Doctorate degree & 2 years of directly related experience OR -Master’s degree & 6 years of directly related experience OR -Bachelor’s degree & 8 years of directly related experience OR -Associate’s degree & 10 years of directly related experience OR -High school diploma / GED & 12 years of directly related experience Preferred Qualifications MBA preferred 5+ years of Strategic Sourcing experience 3+ years Biotech/Pharmaceutical experience 7+ years experience in a complex business environment Certified Purchasing Manager (CPM), Project Management Professional (PMP), and/or Green/Black Belt Six Sigma certification Category sourcing experience in Research and Development categories such as scientific services, or laboratory support services General understanding of Biotech/Pharmaceutical practices and standards In-depth knowledge of the principles, methods and practices as they relate to strategic sourcing, project management and/or change management Experience contributing to the development of a category strategy with business partners Ability to translate company goals into category priorities, strategy and direction Ability to work in a complex business environment Applies data gathering and analytical skills to drive fact based decision making Develop innovative and creative outputs based on insightful interpretation and analysis Ability to define opportunities and risks and facilitate selection of appropriate alternatives Ability to proactively identify roadblocks and effectively identify and execute solutions Plan, track and report progress of sourcing related initiatives Work independently to establish initiative timeline, managing deliverables and ability to appropriately identify and escalate issues when needed Ability to build productive internal relationships and strategic supplier partnerships Demonstrated negotiation, conflict resolution and stakeholder management capabilities Strong oral and written communication skills and excellent organization and planning skills2012-03-08 19:14:42United StatesAmgenCalifornia14193BRCAThousand Oaks, CA27012304http://www.amgen.jobs/xml/27012304/jobIRLDublinAuto req 14039BR Job Posting Title 2 x Manager Manufacturing - Syringe Filling & Inspection Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Manager Manufacturing –Syringe Filing & Inspection Amgen Dun Laoghaire - Dublin Overview: The Manager Manufacturing – Syringe Filling & inspection reports to the Sr Manager Manufacturing – Syringe and will be responsible for the manufacturing teams within the syringe filling facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry. Responsibilities include: • Responsible for filling and inspection line output during their shift. • Responsible for ensuring that all staff operate within GMP’s and maintaining a safe work environment. • Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc. • Responsible for ensuring that all staff operate within GMP’s and maintaining a safe work environment. • Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment. • Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met. • Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits. • Prepared to work on a shift basis, leading a manufacturing team. • Able to travel to other sites within the organization for certain time periods. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering or Science Relevant Experience • Typically 5 – 8 years experience in an aseptic pharmaceutical environment.2012-03-07 02:05:41IrelandAmgenNone14039BRNoneDublin, IRL26971935http://www.amgen.jobs/xml/26971935/jobIRLDublinAuto req 14042BR Job Posting Title Sr Engineer - Packaging (Line Owner) Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Sr. Engineer – Packaging (Line Owner) Level 5 Amgen Dun Laoghaire - Dublin Overview: This position will be part of the packaging group and be responsible for the execution of all projects in that area. The Sr. Engineer reports to the Sr. Manager Manufacturing –Packaging. The candidate will have knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering relating to packaging equipment and associated automation systems. Responsibilities include: The chosen candidate would typically be involved in activities such as (but not exclusively); • Monitoring of day to day manufacturing operations. • Data trend analysis for all performance aspects of a packaging line. • The definition and scoping of all process improvement activities relating to the area. • Solving or escalating problems as appropriate. • All design reviews associated with equipment purchases. • Troubleshooting performance trends. • Risk assessments and mitigation projects relating to line performance. • Support of new product introductions and supporting introduction of new equipment. • The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad. • Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site. • Continuous improvement programs and all performance improvement projects. • Review and approval of changes to operating procedures and the change control process relating to the line. • Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals. • Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc. • Supporting non conformance investigation. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering (Mechanical, Electrical or Chemical) • Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries. • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. • Significant relevant industrial project experience Preferred Qualifications Preferred Experience • Typically 8+ years engineering experience in an aseptic pharmaceutical environment • Significant experience large project related activities including GMP qualification experience.2012-03-07 02:05:14IrelandAmgenNone14042BRNoneDublin, IRL26971791http://www.amgen.jobs/xml/26971791/jobIRLDublinAuto req 14037BR Job Posting Title 4 x Manager Manufacturing - Packaging Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Manager Manufacturing – Packaging Amgen Dun Laoghaire - Dublin Overview: The Manager Manufacturing – Packing reports to the Sr Manager Manufacturing – Packaging and will be responsible for the manufacturing teams within the syringe packaging facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry. Responsibilities include: • Responsible for filling and inspection packaging line output during their shift. • Responsible for ensuring that all staff operates within GMP’s and maintaining a safe work environment. • Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc. • Responsible for ensuring that all staff operates within GMP’s and maintaining a safe work environment. • Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment. • Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met. • Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits. • Prepared to work on a shift basis, leading a manufacturing team. • Able to travel to other sites within the organization for certain time periods. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering or Science Relevant Experience • Typically 5 – 8 years experience in an aseptic pharmaceutical environment. • Previous experience working on packaging lines in a man management role is a distinct advantage.2012-03-07 02:05:13IrelandAmgenNone14037BRNoneDublin, IRL26971785http://www.amgen.jobs/xml/26971785/jobIRLDublinAuto req 14038BR Job Posting Title Senior Engineer - Industrial Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Sr. Engineer – Industrial Amgen Dun Laoghaire - Dublin Overview: This position will be part of the packaging and syringe groups and be responsible identifying and remediating gaps between emerging business requirements and current capabilities within the filling and packaging operations. The Sr. Engineer reports to the Sr. Manager Manufacturing – Syringe. Responsibilities include: The chosen candidate would typically be involved in activities such as (but not exclusively); • Performing resource assessments for each area and developing resource standards and labour models • Data trend analysis for all performance aspects of the area. • The definition and scoping of all process improvement activities relating to the area. • Solving or escalating problems as appropriate. • Leading improvement initiatives in areas of waste reduction, right first time approaches and productivity improvement. • Troubleshooting performance trends. • Risk assessments and mitigation projects relating to line performance. • Performing resource gap analysis for machinery and labour and developing strategies to close these gaps. • Continuous improvement programs and all performance improvement projects. • Working with the operational excellence group in implementing OE methods, mentoring project leads and facilitating process improvement teams. • Review and approval of changes to operating procedures and the change control process relating to the line. • Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering (Mechanical, Electrical or Chemical) • Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries. • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. • Significant relevant industrial project experience Preferred Qualifications Preferred Experience • Typically 8+ years engineering experience in an aseptic pharmaceutical environment • Qualification in Lean and 6-sigma methodologies would be an advantage. • Significant experience large project related activities including GMP qualification experience.2012-03-07 02:05:06IrelandAmgenNone14038BRNoneDublin, IRL26971749http://www.amgen.jobs/xml/26971749/jobRUSMoscowAuto req 14087BR Job Posting Title Accounting Mgr Career Category Finance Employee Subgroup Salaried FT Country (State/Region) Russia Location (City) Moscow Amgen Job Description Responsibilities: · Responsible for accurate, complete and timely monthly and quarterly US GAAP accounting close: · Use and review of month-end accounting checklist · Responsible for preparation of manual Journal Entries and review of manual journal entries posted by other affiliate accounting staff · Responsible for the preparation of the quarterly account analyses · Responsible for Statutory quarterly closing: taxes and financial statements · Ensure compliance to local accounting requirements , corporate internal controls, including reconciliation between Amgen US GAAP books and statutory · Support local Finance lead with tax compliance, internal and external audit as well as Control Self Assessment exercises and implementation of recommended improvements · Monitor relationship with outsourcing accounting vendor provider and European SSC · Take leading part from accounting side in SAP implementation project – 2012 target, then key user · Ensure timely and accurate preparation of Quarterly Close and Disclosure Checklists (US GAAP) · Supports implementation of local accounting and other relevant business practices and guidelines (i.e. procedures and policies) in line with International and Corporate guidance · Support local HR Lead with compliant local payroll process · Be a close and reliable business partner to local Finance team · Takes part in any local or International finance and/or accounting project Basic Qualifications * Mimimum of 3-5 years of accounting experience in an International company * Solid understanding of local (Russian) accounting principles (experience in all areas, financial statements and tax declarations preparation) * Strong understanding of US-GAAP/Local GAAP * Ability to communicate effectively with others and provide timely, accurate information. * Ability to work under limited supervision and tight deadlines * Experience in public accounting a plus. * SAP system knowledge required * Fluent English and Russian (speaking and writing) Preferred Qualifications Personal skills: - Leadership - Focus on results - Learning agility - Ability to work with multifunctional tasks - Proactivity - Good time management Preferred Requirements · Experience in Pharmaceutical Industry · Experience in implementation of ERP system · Team management · Tax inspection/audit experience2012-03-07 02:04:57RussiaAmgenNone14087BRNoneMoscow, RUS26971735http://www.amgen.jobs/xml/26971735/jobIRLDublinAuto req 14211BR Job Posting Title 2 x Sr Associate Tech Engineering - Syringe Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Sr. Associate Tech Engineer - Syringe Amgen Dun Laoghaire - Dublin Overview: The Sr. Associate Tech Engineer operates as part of a process team. This position will initially be part of the team responsible for the commissioning, qualification and start up of Amgen’s new syringe manufacturing facility. On completion of the start up, this position will transition to providing technical support to the manufacturing facility. Key Responsibilities: During start up the individual will execute all project activities associated with start up of the syringe line, including but not limited to: • Participation in equipment design reviews. • Development and execution of FAT, SAT, IOQ protocols. • Development, revision and review of technical documents such as SOP’s, job plans etc. • A willingness to spend time abroad over the next 2 years. • Ensuring that work is completed in a safe manner under GMP conditions and in accordance with applicable Amgen procedures. During routine manufacturing operations, the individual will provide technical support to the syringe line by: • Ensuring that daily output and compliance requirements are met. • Tracking equipment and process performance to ensure compliance with operating standards. • Implementing corrective actions when deviations from standard are detected. • Ensuring that maintenance personnel have clear definition/guidance when equipment problems are encountered and improvement is required. • Working to investigate, resolve and closeout all issues relating to NC’s, CAPA’s, process deviations. • Owning manufacturing area SOP’s and change control reports. Basic Qualifications Basic Qualifications: • Degree in Engineering/Science or equivalent • Significant relevant process engineering industry experience Key competencies: • Analytical thinking • Focus on quality • Drive for results • Initiative • Planning and prioritisation • Teamwork and Co-operation Preferred Qualifications Preferred Qualifications. • Excellent written and verbal communication skills • Knowledge of applicable Regulatory requirements • Experience with Regulatory inspections desirable • Experience leading cross-functional teams desirable • Experience working with teams and influencing decisions2012-03-07 02:04:45IrelandAmgenNone14211BRNoneDublin, IRL26971668http://www.amgen.jobs/xml/26971668/jobIRLDublinAuto req 14219BR Job Posting Title 2 x Manager Manufacturing – Syringe, Component Prep & Formulation Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Manager Manufacturing – Syringe, Component Prep & Formulation Amgen Dun Laoghaire - Dublin Overview: The Manager Manufacturing – Syringe, Component Prep & Formulation reports to the Sr Manager Manufacturing – Syringe and will be responsible for the manufacturing teams within the syringe filling facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry. Responsibilities include: • Responsible for filling and inspection line output during their shift. • Responsible for ensuring that all staff operate within GMP’s and maintaining a safe work environment. • Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc. • Responsible for ensuring that all staff operates within GMP’s and maintaining a safe work environment. • Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment. • Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met. • Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits. • Prepared to work on a shift basis, leading a manufacturing team. • Able to travel to other sites within the organization for certain time periods. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering or Science Relevant Experience • Typically 5 – 8 years experience in an aseptic pharmaceutical environment. • Previous experience of management of Syringe filling and inspection operations is a distinct advantage.2012-03-07 02:04:18IrelandAmgenNone14219BRNoneDublin, IRL26971519http://www.amgen.jobs/xml/26971519/jobIRLDublinAuto req 14217BR Job Posting Title Engineering Projects Manager - Syringe Fill Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Engineer Project Manager - Syringe Filling Amgen Dun Laoghaire - Dublin Overview: This position will be part of the syringe group and be responsible for the execution of all projects in that area. The equipment engineer reports to the Sr. Manager Manufacturing –Syringe. The candidate will apply technical expertise in the management of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems, facilities or processes. Responsibilities include: The chosen candidate would typically be involved in activities such as (but not exclusively); • Engineering Project lead for Syringe Filing • The provision of manufacturing input to all capital projects relating to the area. • The definition and scoping of all process improvement activities relating to the area. • All design reviews associated with equipment purchases. • The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad. • Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site. • Continuous improvement programs • Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals. • Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering (Mechanical, Electrical or Chemical) • Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries. • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. • Significant relevant industrial project experience Preferred Qualifications Preferred Experience • Typically 8+ years engineering experience in an aseptic pharmaceutical environment • Significant experience large project related activities including GMP qualification experience.2012-03-07 02:04:02IrelandAmgenNone14217BRNoneDublin, IRL26971454http://www.amgen.jobs/xml/26971454/jobUSAThousand OaksAuto req 10935BR Job Posting Title Business Performance Sr Mgr (Commercial) Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role will be focused on North America and International Commercial Operations but may also support other functional areas as well. The Manager of Business Performance will respond to project requests from executives and supervise / execute work with high quality results. In doing so s/he will structure the issues and analyses, manage the work, and prepare and present findings. This role will also support business functions by identifying opportunities and risks and developing the strategies to address them. The Sr. Manager of Business Performance will be responsible for developing approaches to improve productivity and implement comprehensive change strategies to transform an organization and enable it to adapt to business challenges. This role will interact with a wide range of leadership and staff inside and outside of Amgen (consultants). Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Doctorate or Masters in business, finance, science, and/or technology • 5+ years experience in biotechnology /pharmaceutical • Experience at a top tier Management Consulting Firm and/or commercial/marketing/sales experience • Strong presence with Senior Executives including ability to communicate effectively on a prepared and ad-hoc basis • Certification in lean and / or Six Sigma • Experience in budgeting or financial modeling • Strong quantitative and qualitative analytic skills • Excellent conceptual problem solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution • Strong leadership skills with a demonstrated ability to influence different styles • Proven experience as member or leader of a high performing team2012-03-05 21:20:51United StatesAmgenCalifornia10935BRCAThousand Oaks, CA26933434http://www.amgen.jobs/xml/26933434/jobDEUMunichAuto req 14188BR Job Posting Title Strategic Sourcing Senior Manager Career Category Procurement Employee Subgroup Salaried FT Country (State/Region) Germany Location (City) Munich Amgen Job Description The Function is located at the German affiliate and is responsible to: - Secure the availability of services (and goods) in compliance with Amgen’s requirements at minimum total cost and risk (indirect material) - Ensure effective management of local strategy development, selection and contracting processes, supply base control and performance and the operational purchasing process - Ensure an effective/efficient local Sourcing & Supplier management process in accordance with established Procurement policies and guidelines and to ensure early procurement involvement in sourcing projects - Championing and Driving a productivity agenda at the affiliate level, achieving year on year savings through a limited number of large game changing projects KEY RESPONSIBILITIES: • Local, ad-hoc sourcing: - Identify local improvement opportunities with respect to management of Purchase demand, Supply base and Total Cost on a local level - Identify and define specific stakeholder requirements - Tendering: define evaluation/selection criteria, define and manage Request for Information (RFI) and Request for Proposal (RFP) processes on the basis of the local sourcing strategy, derived from the category sourcing strategy - Supplier Selection: evaluate and negotiate proposals, ensure and validate selection of best supplier - Supplier Contracting: Complete and implement the contract in accordance with legal standards and Procurement policies and guidelines • Category Management: - Monitor, analyze and report Affiliate’s actual spend, trends, forecasts and supplier base data - Participate in International category strategy development and in International Sourcing teams - Support Strategic Sourcing infrastructure development and integration • Purchase to pay: - Assist and monitor the operational purchase to pay process for the Affiliate and ensure conformance to procurement process policies and guidelines • Supplier Performance: - Monitor and report supplier performance on the basis of pre-determined, relevant and measurable Key Performance Indicators (KPIs) and establish, agree and implement improvement plans • Reporting: - Benefits Tracking: develop, maintain and report KPIs that clearly reflect the achievement of objectives in each business area The jobholder reports to the International Head of Category Management in Switzerland with a dotted-line to the local Director Finance. Basic Qualifications - Bachelor’s degree in appropriate discipline (technical/economic/administrative) or equivalent Experience and Knowledge - Ideally at least 5 years experience in a profit driven and international dynamic environment with indirect materials - Purchasing knowledge: sourcing process, commodity management and analysis, supplier management and development, pricing theory and policy, negotiation, supply chain, make or buy - Experience with tendering processes, supplier negotiations and contracting including eSourcing - Project Management experience - Fluency in local language and English (both in oral and written communication) - Excellent computer skills (MS office, esp. Excel/Powerpoint) and experience with ERP (SAP) Key Competencies - Analytical and conceptual thinking - Ability and demonstrated experience in leading change programs - Financial and Business Acumen, Results orientation - Excellent negotiation, communication and presentation skills, Leadership skills - Self-starting, assertiveness - Familiar with working in a matrix organization - Ability to engage prople and proactively build up trustful relationships and cooperations Preferred Qualifications We offer the opportunity to develop your career within one of the most innovative and successful companies worldwide, not only to develop your technical skills but also to grow your personality and competencies too. You will find an open and success oriented working environment. Attractive conditions and social benefits are part of our people concept. To upload your application and for further information about AMGEN we invite you to visit our career center on our homepage www.amgen.com. Please upload your application to Req.-No. 14188BR or follow the respective link. In case you have any questions please contact Martina Rech – Staffing Manager, Phone Number +49 89 14 90 96-1112.2012-03-05 21:20:19GermanyAmgenNone14188BRNoneMunich, DEU26933430http://www.amgen.jobs/xml/26933430/jobIRLDun LaoghaireAuto req 14036BR Job Posting Title Sr Mgr Manufacturing - Maintenance Packaging Career Category Maintenance Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Sr. Manager Manufacturing – Maintenance Packaging Amgen Dun Laoghaire - Dublin Overview: This position will report to the Director of Manufacturing & Operations – Packaging. The ideal candidate will provide strong management and leadership in the Manufacturing & Operations – Packaging area. Previous experience with maintaining packaging line equipment is a distinct advantage. Working knowledge of equipment from various vendors would also be advantageous. Key Responsibilities: • Manage the Maintenance of the all the Packaging Equipment within the syringe facility while ensuring Manufacturing smooth and consistent running of all equipment in the Packaging facility which has isolator technology. • Strong operating knowledge of pharmaceutical GMP’s and their application to the maintenance function. • Lead in the development of Manufacturing’s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals. • Responsible for ensuring that all maintenance is carried out under GMP conditions and in a safe working environment. • Support the plant in the project approval, prioritization, and implementation process. • Develop metrics to support the benchmarking of site, global, and industry. • Develop improvement strategies across the Maintenance function. • Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the Maintenance department. • Assure the appropriate level of training is undertaken for all levels of the Maintenance organization which may involve developing training material. • Responsible for attaining and improving site based metrics targets. • Responsible for recruiting talented staff into Maintenance and setting standards for their performance. • This position will need to complete some travel to the other Amgen sites over the next two years. * Other functions may be assigned. Basic Qualifications Basic Qualifications • Typically 8+ years of experience in facilities Maintenance position. With typically 4+ years experience supervising technical staff. • Bachelor’s Degree or combination of education and/or years of experience. • Ideally previous experience working within the Pharmaceutical, and/or manufacturing industries would be highly desirable. Preferred Qualifications Preferred Qualifications# • Knowledge of conflict resolution • Ability to partner with other departments. • Analytical problem solving. • Considerable Organization skills. • Experience in coaching, mentoring and counselling. • Ability to deal with and manage change. • Ability to set goals. • Knowledge of applicable regulatory guidelines • Ability to use company compensation system including mentoring lower management levels when required. • Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.2012-03-03 20:26:16IrelandAmgenNone14036BRNoneDun Laoghaire, IRL26910351http://www.amgen.jobs/xml/26910351/jobIRLDun LaoghaireAuto req 14027BR Job Posting Title Director Manufacturing - Operations & Packaging Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Director Manufacturing – Operations & Packaging Amgen Dun Laoghaire - Dublin Overview: This role will report into the Executive Director Manufacturing and will be responsible for the management of the packaging manufacturing operations, over 4 lines and 2 work centres, at Amgen Dun Laoghaire. The successful Candidate will be responsible for maintenance of the facility, building of the packaging organisation and ensuring the on time delivery of GMP product in a safe and cost effective manner. Key Responsibilities: • Excellent people skills allied to a strong leadership style, with a background in the biotech industry an advantage. • Ensure that the Manufacturing – Operations & Packaging area is staffed with motivated and well trained colleagues and that ongoing programmes are initiated and maintained to ensure flexibility and productivity within the department. • Proven experience in the creation of organisations with a defect elimination mindset and metrics driven culture. • A detailed understanding of the regulatory requirements across different geographies and an extensive knowledge of same would be an advantage. • Develop and maintain an effective organisation through selection, teaching, leadership and development Management. • Define and regularly update our policies for all manufacturing, reflecting prior performance and current needs of the business. Liaise with the relevant supervisors in the course of the day to day activities. • Experience of operations with both high mix and high volume, plus experience with different equipment manufacturers and packaging configurations. • Detailed experience relating to line integration. • The ability to specify the appropriate levels of automation to optimize line efficiency and output quality. • Experience with eliminating glass defects in vials and syringes during packaging operations. • Experience with packaging facility start up and tech transfer programs between different facilities. • Ensure effective two-way communication within the plant, with peers and groups internally and externally. • The ability to adopt a hand’s on approach during start up and commissioning phase. • The capability to undertake significant travel for vendor visits and FAT’s. • Responsibility for maintaining Amgen’s performance management system within the packaging area. Basic Qualifications Basic Qualifications: • Degree in Engineering or Science, with a background in manufacturing, quality, process development. • 10-15 years experience in managing significant packaging operations in a GMP environment. • Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs. Preferred Qualifications Preferred Qualifications: • BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD) • Significant experience in biotechnology, leading development and execution of cross functional, complex technical projects • Strong technical skills related to scale up • Thorough knowledge of GMP biotechnology manufacturing • Solid understanding and knowledge of cGMPs • Awareness and understanding of quality and regulatory industry trends, policies and guidelines • Proven track record of advancement in an established, high performing organization • Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs • Excellent project management skills with the ability to lead effectively in an highly matrixed organization • Excellent communication skills able to work with and influence executive management • Strong understanding of validation of biopharmaceutical facilities, equipment and process • Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately2012-03-03 20:25:43IrelandAmgenNone14027BRNoneDun Laoghaire, IRL26910344http://www.amgen.jobs/xml/26910344/jobIRLDun LaoghaireAuto req 14041BR Job Posting Title Sr Mgr Manufacturing - Maintenance Syringe Career Category Maintenance Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Sr. Manager Manufacturing – Maintenance Syringe Amgen Dun Laoghaire - Dublin Overview: This position will report to the Director of Manufacturing & Operations – Syringe. The ideal candidate will provide strong management and leadership in the Manufacturing & Operations – Syringe area. Previous experience in maintaining syringe manufacturing and inspection equipment is a distinct advantage. Experience with the use and maintenance of isolator equipment would also be advantageous. Key Responsibilities: • Manage the smooth and consistent running of all equipment in the Syringe facility which has isolator technology. • Strong operating knowledge of pharmaceutical GMP’s and their application to the maintenance function. • Lead in the development of Manufacturing’s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals. • Responsible for ensuring that all maintenance is carried out under GMP conditions and in a safe working environment. • Support the plant in the project approval, prioritization, and implementation process. • Develop metrics to support the benchmarking of site, global, and industry. • Develop improvement strategies across the Maintenance function. • Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the Maintenance department. • Assure the appropriate level of training is undertaken for all levels of the Maintenance- Syringe organization which may involve developing training material. • Responsible for attaining and improving site based metrics targets. • Responsible for recruiting talented staff into Maintenance – Syringe and setting standards for their performance. • This position will need to complete some travel to the other Amgen sites over the next two years. * Other functions may be assigned. Basic Qualifications Basic Qualifications • Typically 8+ years of experience in facilities Maintenance position. With typically 4+ years experience supervising technical staff. • Bachelor’s Degree or combination of education and/or years of experience. • Ideally previous experience working within the Pharmaceutical, and/or manufacturing industries would be highly desirable. Preferred Qualifications Preferred Qualifications# • Knowledge of conflict resolution • Ability to partner with other departments. • Analytical problem solving. • Considerable Organization skills. • Experience in coaching, mentoring and counselling. • Ability to deal with and manage change. • Ability to set goals. • Knowledge of applicable regulatory guidelines • Ability to use company compensation system including mentoring lower management levels when required. • Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.2012-03-03 20:25:23IrelandAmgenNone14041BRNoneDun Laoghaire, IRL26910341http://www.amgen.jobs/xml/26910341/jobIRLDun LaoghaireAuto req 14028BR Job Posting Title Dir Manufacturing - Syringe Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Director Manufacturing - Syringe Amgen Dun Laoghaire - Dublin Overview: This role will report into the Executive Director Manufacturing and will be responsible for the manufacturing of syringes at the Amgen Dun Laoghaire Site. The successful candidate will be responsible for the maintenance of the facility and for building an organization that ensures on time delivery of GMP product in a safe and cost effective manner. Key Responsibilities: • Excellent people skills allied to a strong leadership style, with a background in the biotech industry an advantage. • Ensure that the Manufacturing – Syringe area is staffed with motivated and well trained colleagues and that ongoing programmes are initiated and maintained to ensure flexibility and productivity within the department. • Proven experience in the creation of organisations with a defect elimination mindset and metrics driven culture. • A detailed understanding of the regulatory requirements across different geographies and an extensive knowledge of same would be an advantage. • Develop and maintain an effective organisation through selection, teaching, leadership and development Management. • Define and regularly update our policies for all manufacturing, reflecting prior performance and current needs of the business. Liaise with the relevant supervisors in the course of the day to day activities. • Experience with syringe facility start up and tech transfer programs between different facilities. • Experience of syringe inspection operations with previous experience of training of staff in this area an advantage. • Detailed experience relating to all aspects of line integration. • A detailed understanding of the automation requirements necessary to optimize line efficiency and output quality. • Experience with eliminating glass defects in syringes during filling and inspection operations. • Prepares and submit annual expenditure budgets and monitor actual performance against these budgets, taking corrective action where necessary • Ensure effective two-way communication within the plant, with peers and groups internally and externally. • The ability to adopt a hand’s on approach during start up and commissioning phase. • The capability to undertake significant travel for vendor visits and FAT’s. • Responsibility for maintaining Amgen’s performance management system within the syringe filling area. Basic Qualifications Basic Qualifications: • Degree educated with significant relevant experience • Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs. Preferred Qualifications Preferred Qualifications: • BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD) • Significant experience in biotechnology, leading development and execution of cross functional, complex technical projects • Strong technical skills related to scale up • Thorough knowledge of GMP biotechnology manufacturing • Solid understanding and knowledge of cGMPs • Awareness and understanding of quality and regulatory industry trends, policies and guidelines • Proven track record of advancement in an established, high performing organization • Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs • Excellent project management skills with the ability to lead effectively in an highly matrixed organization • Excellent communication skills able to work with and influence executive management • Strong understanding of validation of biopharmaceutical facilities, equipment and process • Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately2012-03-03 20:24:47IrelandAmgenNone14028BRNoneDun Laoghaire, IRL26910336http://www.amgen.jobs/xml/26910336/jobGBRUxbridgeAuto req 14152BR Job Posting Title Corporate Communications Senior Mgr Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Uxbridge Amgen Job Description Overview: The jobholder will be accountable for the development and implementation of a UK-wide internal communications plan to include staff engagement strategies and activities; International R&D messaging; audience insights; use of appropriate channels; communication programs into global R&D and the International Organisation. The jobholder will lead and manage assigned International projects and provide internal and change communications counsel to key assigned internal stakeholders Key Responsibilities: - Apply a solid understanding of the business and assigned client goals and priorities, as well as the issues clients face locally, to provide effective communications guidance and recommendations. - Develop and support implementation of UK-wide staff engagement and communications plan Serve as a member of the ALMT, flagging new developments, opportunities, threats, making recommendations and sharing best practice. - Partner closely with R&D executives, HR and affiliate leadership, as well as affiliate communicators, to ensure internal/ external and business alignment - Facilitate effective relationships between different functions in UK on all relevant communications activities. - Serve as single point of contact for Global Communications and client groups requiring UK or assigned functional and regional support. - Provide insights/ updates to the Global R&D communications team to ensure that IRD is better understood and integrated into global functional communications. - Ensure IRD is adequately represented and addressed in International (regional) communications. - Develop and manage local internal communications infrastructure and tools. - Build and sustain relationships with key internal stakeholders. - Develop and support implementation of internal communications plans consistent with Amgen’s global, functional and International communications strategies, and aligned with local/ functional/ regional objectives. Basic Qualifications - Bachelor's Degree in English, Journalism, Communications or the equivalent combination of education and experience Preferred Qualifications Experience and Skill: - Relevant experience and proven track record in international corporate communications, ideally gained in pharmaceutical or healthcare; agency experience a plus - Broad communications experience, with depth in internal communications and change management - Demonstrated business acumen, and proven track record of advising executives and leadership - Ability to select, engage and manage a public relations firm - Outstanding oral, written and presentation skills - Strategic approach to communications and program development - Excellent written and verbal command of English (mother tongue preferred); proficiency in other languages an advantage Knowledge: - Knowledge of pharmaceutical/ biotech industry - Knowledge of digital and interactive media and how to apply it to internal communications - Cultural understanding - Knowledge of change management2012-03-02 18:38:02United KingdomAmgenNone14152BRNoneUxbridge, GBR26890895http://www.amgen.jobs/xml/26890895/jobUSAThousand OaksAuto req 14117BR Job Posting Title Principle Scientist - Plastics, Product and Process Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This high level position for a subject matter expert within the Product and Process Engineering Organization is responsible for providing scientific and technical leadership and strategic direction to the evaluation of designated raw materials, in this case plastics used in single use biopharmaceutical applications, and their potential impact on product quality and process performance. REsponsible to assess the impact of changes in materials or manufacturing processes. This individual will be responsible for assessing supplier capabilities, technical competences and understanding of the needs of biopharmaceutical manufacturers along with other team members. The successful candidate will support or lead cross-functional teams of experienced scientists and engineers through project challenges and mentor them in the selection of the most appropriate materials and technologies. The candidate will actively chart the course and translate business strategies into challenging, actionable objectives and plans, and will apply meaningful metrics for projects, personnel and other resources. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • PhD in materials science with specialization in polymers, or multiple years in the manufacture of pharmaceutical plastics • Ten years relevant work experience in use of plastics materials in biopharmaceutical applications • Knowledge of license applications and the drug development process • Familiarity with all aspects of the use of plastics in biopharmaceutical applications, current state of the art technologies and emerging scientific directions. • Leadership experience of progressively increased scope. • Strong interdisciplinary project management skills. • Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects. • Should be recognized in the scientific community and supplier base through a sustained record of publications and patents. • Should have strong communication skills, both written and oral. He/she must network and build solid working relationships across departments, with diverse and remote staff and with external collaborators from key suppliers. • Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans. • Team leadership, management, and facilitation skills are required. Should be willing to travel (approx 30%) to other Amgen sites and/or support supplier technical assessments or audits at short notice domestically and overseas. • Extensive knowledge of the manufacturing processes, usage, regulatory requirements, practices, scientific properties and risks associated with the raw materials for pharmaceutical and biological products.2012-03-02 18:37:59United StatesAmgenCalifornia14117BRCAThousand Oaks, CA26890893http://www.amgen.jobs/xml/26890893/jobUSAThousand OaksAuto req 14072BR Job Posting Title Sr Associate Mfg Career Category Operations Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Under minimal supervision, the Sr. Associate, Mfg, will routinely perform complex to critical processes according to Standard Operating Procedures in the Manufacturing area, specifically the manufacturing of sterile products. Individual will perform a variety of operations involving the support of aseptic filling, with focus in the operation of automated fill equipment inside the aseptic environment. The individual will support and/or be responsible for the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions for the aseptic filling process. The individual will need to apply process, operational expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. Candidates should have strong computer skills, GMP knowledge, cGMP Documentation skills, and be able to assemble, disassemble, operate and understand equipment per procedures. • Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. • Evaluate, plan, and implement solutions for process improvement opportunities. • Provide troubleshooting support. • Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process. • Assist with managing investigation closure within established goal. • Assist with equipment/system Root Cause Analysis investigations and support trend evaluations. • Participate in the New Product Introduction process to assess requirements for documentation, materials, training, and equipment modifications. • Assist manufacturing change owner on Change Control packages impacting the process. • Train operations personnel on new processes or changes to process • Assist with overseeing engineering studies • Prepare, review, approve, and provide technical support for preparation and execution of relevant technical documents, as required. Basic Qualifications • Master’s degree OR • Bachelor’s degree & 2 years of directly related experience OR • Associate’s degree & 6 years of directly related experience OR • High school diploma / GED & 8 years of directly related experience Preferred Qualifications • Bachelor’s degree in Mechanical Engineering with 2 or more years of experience in biopharma. • Demonstrated ability organizing and leading projects • Experience working within biopharma formulation and filling of parenteral products • Clear understanding of cGMPs. • Strong computer skills. • Strong cross functional communication • Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height. • Knowledge of aseptic, barrier (RABs), or isolator technology for parenteral filling operations. • Experience working hands on with equipment and processes and to train other technical staff and operators.2012-03-01 23:11:26United StatesAmgenCalifornia14072BRCAThousand Oaks, CA26874101http://www.amgen.jobs/xml/26874101/jobUSAThousand OaksAuto req 14067BR Job Posting Title Associate Mfg Career Category Operations Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Under minimal supervision, an Associate, Mfg, will routinely assist in performing complex to critical processes according to Standard Operating Procedures in the Manufacturing area. Individual will be responsible for the manufacturing of sterile products. Individual will perform a variety of operations involving the support of aseptic filling, primarily operation of automated fill equipment inside the aseptic environment. Candidates should understand basic computer skills, have GMP knowledge, good cGMP Documentation skills, and be able to assemble, disassemble, operate and understand equipment per procedures. Will need to be available to work non-standard shifts, evenings and/or weekends. Major duties will include: • Operation of the fill/stoppering equipment to dispense sterile product into glass containers • Environmental monitoring of the aseptic environment during each fill and after each fill • Loading and unloading of sterile products from freeze dryers • Operation of the continuous particulate monitoring system during each fill • Assembling and disassembling of equipment before and after use • Performing operations during fills by following proper procedures • High levels of housekeeping to conform to cGMP standards • Cleaning and sanitizing aseptic filling areas to maintain the quality of the product • Detailed and accurate documentation in batch production records. • Able to determine availability of components and assign accordingly. • May also be required to assist in training of co-workers. • Able to perform in the aseptic filling areas while maintaining the integrity and cleanliness of these areas by utilizing aseptic gowning requirements and techniques. Basic Qualifications • Bachelor’s degree OR • Associate’s degree & 4 years of directly related experience OR • High school diploma / GED & 6 years of directly related experience Preferred Qualifications • Bachelors Degree in Mechanical Engineering, or Technology. • Exposure to aseptic filling, biopharma manufacturing equipment, trouble shooting and moving machinery. • Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height. Need color perception/discrimination, far vision correctable with eye glasses. • cGMP manufacturing experience including mechanical ability/expertise. • Demonstrate technical writing capability. • Demonstrate project management skills, presentation skills, and be able to independently collaborate with outside resources.2012-03-01 23:11:11United StatesAmgenCalifornia14067BRCAThousand Oaks, CA26874098http://www.amgen.jobs/xml/26874098/jobUSAThousand OaksAuto req 14150BR Job Posting Title Principal Scientist (Quantitative Pharmacology/PKDM) Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen, Thousand Oaks, CA is seeking a highly motivated and team-oriented candidate for the position of Principal Scientist in the Quantitative Pharmacology Group of PKDM Department. The Principal Scientist will be the PKDM Development Project Team Representative on the Early and/or Global Development Teams in the area of Oncology. He/she will support small and large molecule drug development, registration, and post-marketing activities. He/she will be responsible for program-level strategic and resource planning, communication, scientific/technical deliverables, issue resolution, and functional representation for Amgen internal governance reviews, face-to-face interactions with global regulatory authorities, and external scientific communities. The individual will effectively lead PKDM Development Project Team, and interface with internal business stakeholders (such as Clinical Development, Early Development, Biostatistics, Regulatory Affairs, Research, Toxicology, etc.). This PKDM Development Project Team Reprehensive will be responsible for the PK, PK/PD, and Modeling & Simulation strategy in the Early and Global Development Teams, prepare regulatory documents as a PK/PD expert, and represent Amgen PKDM Department in the global regulatory interactions. Development of junior members and interaction with the line-management will also be key responsibilities. Basic Qualifications - Doctorate degree & 5 years of scientific experience OR - Master’s degree & 12 years of scientific experience OR - Bachelor’s degree & 15 years of scientific experience Preferred Qualifications - PhD (or MS/BS with equivalent experience) in PK, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 7+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training is required - Established track-record as a PKDM and/or Clinical Pharmacology functional representative on product development team(s) in Oncology with working knowledge in bioanalytical and drug metabolism - Experience in PK/PD modeling and population-based analyses/simulations (e.g. hands-on experience for software such as NONMEM, S-PLUS, Clinical Trial Simulator, etc) and PK analysis (e.g. proficiency in WinNONLIN) - Experience in authoring regulatory documentations (IND, IMPD, CTX, RTQ, CTD, etc), knowledge in global regulatory requirement and guidance, and interaction with global health authorities - Leadership quality for effective team building with strong decision making and problem solving skills - Excellent interpersonal, technical, and communication skills that enable effective management and resolution of complex issues involving collaborations within a cross-functional team setting - Project management skills for timeline tracking and resource planning - Comprehensions in R&D processes for small molecules and/or protein therapeutics. General understanding in biology (mechanism of action)/pharmacology, toxicology, clinical immunology, protein sciences, statistics, pharmaceutics, and clinical development, etc.2012-02-29 22:31:16United StatesAmgenCalifornia14150BRCAThousand Oaks, CA26849248http://www.amgen.jobs/xml/26849248/jobUSASeattleAuto req 14154BR Job Posting Title Director Preclinical (Quantitative Pharmacology/PKDM) Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - Washington Location (City) Seattle Amgen Job Description Amgen, Inc. is seeking a highly motivated candidate for the position of Director in the Quantitative Pharmacology Group of the PKDM Department. The Director will provide strategic vision and portfolio leadership in support of small and large molecule drug development, registration, and/or post-marketing activities. He/she will be responsible for portfolio-level strategic and resource planning, communication, scientific/technical deliverables, and issue resolution. A key focus will be to serve as functional representation for Amgen internal governance reviews and external scientific and regulatory communities including face-to-face interactions with global regulatory/health authorities. The individual will interface with internal business stakeholders (such as Research, Toxicology, Early Development, Clinical Development, Biostatistics, CMC, Regulatory Affairs, etc.). The candidate will mentor and advise a group of project team representatives at all stages of discovery and clinical development and implement advanced modeling & simulation (M&S) strategies across the portfolio to influence decision making. The individual will be responsible for the development of key operational efficiencies and new technologies within the quantitative pharmacology group. Basic Qualifications - Doctorate degree & 7 years of scientific experience Preferred Qualifications - PhD in Pharmacokinetics, Pharmaceutical Sciences, or with equivalent professional degrees (e.g. MD, PharmD) with 10 years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training - Experience as PKDM/Clinical Pharmacology functional representative on product development teams - Experience with PK and PK/PD data analysis, interpretation, and reporting for small molecule and/or protein therapeutics - Hands-on experiences in population PK/PD modeling and simulations (M&S) - Experience in authoring regulatory documentations (IND, IMPD, CTX, RTQ, CTD, etc), knowledge in global regulatory requirement and guidance, and interaction with global health authorities - R&D experience in oncology therapeutics, inflammation and/or metabolic therapeutic areas - Leadership quality for effective team building with strong decision making and problem solving skills - Excellent interpersonal, technical, and communication skills to lead a group of quantitative pharmacology scientists - Excellent problem scoping, planning and business skills necessary to drive decision making and influence senior leadership - Project management skills for timeline tracking and resource planning - Solid publication record as senior author and growing reputation with external peers. - The successful candidate will have strong interpersonal communication and leadership skills.2012-02-29 22:30:57United StatesAmgenWashington14154BRWASeattle, WA26849234http://www.amgen.jobs/xml/26849234/jobUSAThousand OaksAuto req 14148BR Job Posting Title Sr Scientist (Quantitative Pharmacology/PKDM) Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen, Thousand Oaks, CA is seeking a highly motivated and team-oriented candidate for the position of Senior Scientist in the in the Quantitative Pharmacology Group of Pharmacokinetics and Drug Metabolism (PKDM) Department. The Senior Scientist will serve as a PK/PD expert to support early and late development programs in various therapeutic areas (e.g. Neurosciences, Cardiovascular, or other therapeutic areas). The individual will effectively interface within the PKDM department and with external functions (such as Early Development, Clinical Development, Biostatistics, Statistical Programming, Clinical Data Management, Regulatory Affairs, etc.). The successful candidate will develop PK/PD strategy, perform modeling & simulation analyses and report writing, and prepare regulatory document sections as appropriate. This individual may also serve as a PKDM Development Project Team Reprehensive who will be responsible for the PK, PK/PD, and Modeling & Simulation strategy in the Early and Global Development Teams, prepare regulatory documents as a PK/PD expert, and represent Amgen PKDM Department in the global regulatory interactions. Development of junior members and interaction with the line-management will also be key responsibilities. Basic Qualifications - Doctorate degree & 2 years of scientific experience OR - Master’s degree & 8 years of scientific experience OR - Bachelor’s degree & 10 years of scientific experience Preferred Qualifications - PhD (or MS/BS with equivalent experience) in PK, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 3+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training is required - Specialized in PK/PD modeling and population-based analyses/simulations (hands-on experience for software such as NONMEM, S-PLUS, Clinical Trial Simulator, etc). - Established track-record as a PKDM and/or Clinical Pharmacology functional representative on product development team(s) - Excellent interpersonal, scientific, technical, and communication skills that enable effective management and resolution of complex, project-related issues involving multiple functional areas and levels of management. - Knowledge of PK and PK/PD for small molecule and/or protein therapeutics. - Leadership quality for effective team building with strong decision making and problem solving skills - Experience in authoring regulatory documentation (IND, IMPD, CTX, etc) and interaction with regulatory authorities. - Experience as PK/PD lead on discovery or development project teams in Neurosciences, Cardiovascular, or other therapeutic areas.2012-02-29 22:30:55United StatesAmgenCalifornia14148BRCAThousand Oaks, CA26849231http://www.amgen.jobs/xml/26849231/jobUSAThousand OaksAuto req 14057BR Job Posting Title Principal IS Automation Engineer Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role will act as the Operations Information Systems (OIS) automation project leader for site projects including expansions and upgrade activities. The individual will build consensus between the individual requirements of facility management, Corporate Engineering, OIS, and corporate standard architectures to design the project specific automation architecture for project activities. Key Accountabilities: • Automation Project Leader for site projects including expansions and upgrade activities, providing day to day technical leadership to the project team in all project phases (design, delivery, startup, commissioning, validation and operational support • Ensure the project budget, schedule and staffing is commensurate to enabling the Process Control Systems (PCS), Manufacturing Execution Systems (MES), Building Automation Systems (BAS), and Plant Information Systems to attain the performance standards required to support the business objectives. • Act as client interface, point of escalation and resolve client concerns, developing and reporting project results, technical guidance of a project from concept to delivery, detailed project planning, management of suppliers/contractors/Systems integrators/OEMs, system commissioning and validation, technical solution evaluation, schedule tracking. • Lead and manage staff, the jobholder will direct the activity of others in matrix, internal or external reporting relationships • Build strong relationships with stakeholders, contribute to key decision making and influence the development of business area strategy where appropriate. • Operational vendor management and contract negotiations with focus on Automation Systems Integrators and OEM suppliers. • Ensuring compliance with practices, policies, procedures, legal requirements and goals of project sponsors and approved methodologies, develop supporting documentation and monitor budget tracking/ timeliness/ scheduled resources. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Ability to translate strategic opportunities within biopharma and emerging technology solutions into tangible pragmatic executable plans allied to the ability to apply corporate blueprint and standards using business drivers to local business needs and project requirements. • Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical, project management, and business expertise. • Working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies to establish a PCS, BAS, and MES implementation and Systems Integration that meets Operations' business requirements. • Experience with Rockwell Automation PLC/SCADA/Batch, Emerson DeltaV, OSIsoft PI Data Historian, Werum MES and Siemens BAS is preferred. • Experience with designing information interfaces, data conversion, and network and infrastructure fundamentals.2012-02-29 22:30:20United StatesAmgenCalifornia14057BRCAThousand Oaks, CA26849217http://www.amgen.jobs/xml/26849217/jobUSAThousand OaksAuto req 14147BR Job Posting Title Clinical Research Sr Medical Scientist - Cardiology Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Clinical Research Sr. Medical Scientist is responsible for: - Supporting the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan - Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program - Participating and providing clinical input into safety and regulatory interactions - Provide clinical/scientific input during the development and execution of clinical trials - Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols) - Interpret clinical trial data - Participate in safety assessments - Review and provide clinical scientific input to TLGs and safety narratives - Review scientific literature - Initiate database analyses to support commercial/clinical objectives - Contribute to the preparation of clinical study reports and regulatory submissions - Participate in interactions with regulatory agencies - Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Clinical Scientists, NAML, or GDL - Identify new clinical research opportunities Knowledge: - Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale - Familiarity with concepts of clinical research and clinical trial design, including biostatistics - Medical knowledge in the relevant therapeutic area - Sound scientific and clinical judgment - Familiarity with regulatory agency organization, guidelines, and practices - Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication - History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues Basic Qualifications M.D. degree Preferred Qualifications - M.D. plus accredited residency in Cardiology, board certified or equivalent - Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities2012-02-29 22:29:59United StatesAmgenCalifornia14147BRCAThousand Oaks, CA26849201http://www.amgen.jobs/xml/26849201/jobUSAThousand OaksAuto req 14074BR Job Posting Title Dir Engineering - Human Factors and Industrial Design - Drug Delivery Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The successful Director of Human Factors and Industrial Design Engineering (HF/ID) will lead human factors and industrial design activities for development of Amgen drug delivery devices/systems taking into consideration all aspects of the user, the intended use, the use environment (eco-system), and the drug therapy being delivered. The Director will collaborate with marketing, engineering, quality, manufacturing and regulatory team members to create innovative and intuitive-to-use products through the application of human-centered design methodologies through Usability assurance, determination of desired user profiles, development of user documentation, and development of training programs. The Director will partner with marketing to lead internal and external team activities that assure brand driven aesthetics are applied consistently across the entire product portfolio. The successful candidate will be responsible for independently leading the planning, execution and reporting of human factors engineering, user interface and industrial design studies across all device programs according to current regulations and guidelines within the medical device and bio-pharmaceutical industries. The Director HF/ID will ensure that expert HF/ID input is provided to device design teams for establishing design requirements, packaging requirements, training requirements and use instructions. The Director HF/ID will ensure that HF/ID expertise is applied to create and complete design validation activities and clinical studies in support of regulatory submissions. Further, the Director HF/ID will ensure that human factors engineering concepts are incorporated early in the development process based on industry best practices. The Director HF/ID will act as a key advocate for these principles across Amgen. Ensures • Human-system capabilities and limitations are properly reflected in the system requirements • Human-system performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs) • Human-system performance and safety risks are appropriately addressed in program baseline • Determine the human factors cost, benefit, schedule, and performance baselines for each candidate solution • Identify the human factors and human performance measures and thresholds to be achieved (e.g., for the equipment, software, environment, support concepts, and configurations expected for the solution) • Determine the human factors activities to be undertaken during the program, the schedule for conducting them, their relative priority, and the expected costs to be incurred • Calculate or estimate the relative or absolute benefits of the human factors component of each solution in terms of decision criteria (e.g., cost, schedule, human-system performance The position requires excellent organizational, technical problem solving and communication skills (written and verbal), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to lead external design consultants. Basic Qualifications • Doctorate degree & 4 years of applied HF/ID engineering experience OR • Master’s degree & 8 years of applied HF/ID engineering experience OR • Bachelor’s degree & 10 years of applied HF/ID engineering experience AND • 4 years of engineering managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Bachelor's degree in Human Factors, Industrial Design, Cognitive Psychology, or other Engineering/Life Sciences related discipline and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments. • MS in Human Factors, Industrial Design, Cognitive Psychology, or other Engineering/Life Sciences related discipline • Certified Professional Ergonomist (CPE), Certified Human Factors Professional (CHFP), Certified User Experience Professional (CUXP), Associate Ergonomics Professional (AEP), Associate Human Factors Professional (AHFP), Associate User Experience Professional (AUXP) or Certified Ergonomics Associate (CEA). • Minimum of 8+ years experience working in the development of electro-mechanical systems design, verification and validation • Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools • Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected • Experience with complex, cross-functional development projects • Experience working with and leading cross-cultural teams • Proven ability to apply situational leadership concepts across various intra and inter-departmental matters • Demonstrated time management, decision making, presentation and organization skills • Previous experience in HF/ID engineering and commercialization process with drug delivery devices and combination drug/device products is desired • HF/ID experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal) • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines The position requires also requires the following: • Proven experience in the HF/ID principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/analysis • Proven experience with using sketch models, low and high fidelity prototypes to identify and eliminate potential use errors early in the development process • Experience working directly with customers to gather, synthesize and convert user research into concepts that differentiate products in the market • Experience working directly with customers to develop and evaluate new product features, user interfaces and ergonomic designs, and with ensuring customer satisfaction • Thorough knowledge of relevant human factors regulations, standards and guidance for medical devices and pharmaceutical packaging • Good understanding of the principles of Medical Device and healthcare regulations including FDAs Quality System Regulation (QSR), ISO 13485:2003, 14971, EN 60601, Council Directive 93/42/EEC, etc. • Experience in design of formative and summative human factor studies to address the needs of the requirements setting, design testing, verification and validation stages of medical device development • Experience in writing human factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports) • Proven leadership and experience managing multiple projects with high demand schedules • Experience in management of external partners • Experience with establishing departmental or program objectives following company policies and establishing procedures that are measureable with outcomes can be quantified2012-02-25 18:46:50United StatesAmgenCalifornia14074BRCAThousand Oaks, CA26756596http://www.amgen.jobs/xml/26756596/jobUSASouth San FranciscoAuto req 14023BR Job Posting Title Sr Scientist - Pharmaceutics Career Category Scientific Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Amgen Job Description The position responsibilities include independently designing and conducting preformulation characterization of small molecules, developing formulations to support in-vivo animal studies, solid state characterization and salt and form selection for clinical candidate. The position responsibilities also include developing small molecule parenteral formulation for clinical use. A successful candidate will participate and represent pharmaceutics in a multi-disciplinary team, supervising scientific projects, providing critical evaluation of scientific data and results, and providing technical mentoring and expertise to associate level staff. Basic Qualifications Doctorate degree & 2 years of scientific experience OR Master’s degree & 8 years of scientific experience OR Bachelor’s degree & 10 years of scientific experience Preferred Qualifications A Ph.D. in Pharmaceutical Chemistry, Physical Chemistry, Physical Organic Chemistry, Organic Chemistry, or scientific field 3+ years of relevant post doctoral and industrial experience. A thorough understanding of basic pharmaceutics such as solubility, physicochemical properties, and chemical stability. Experience in developing small molecule parenteral clinical formulation as well as an understanding and familiarity with the solid-state characterization techniques (DSC, TGA, XRPD, microscopy, moisture uptake, HPLC etc). Good communication skills (oral and written), good computer skills, and problem solving skills are required.2012-02-24 19:34:10United StatesAmgenCalifornia14023BRCASouth San Francisco, CA26740014http://www.amgen.jobs/xml/26740014/jobGBRCambridgeAuto req 13694BR Job Posting Title Sr Associate IS Bus Sys Analyst Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Uxbridge Amgen Job Description Overview: The jobholder will provide technical support and leadership across International Drug Safety functions, developing, maintaining and operating new and existing services whilst meeting Information Systems (IS) technical standards and business requirements. Relevant domain experience of Drug Safety business processes and technologies will be strongly favoured. Key Responsibilities: • Provide technical 2nd and 3rd line support for Amgen Business Applications • Provide co-ordination of major incidents relating to Safety applications support where required • Intake of all Global Safety change requests related to Regulatory Reporting Rules and E2B requirements, analysis with business to clarify requirements , prioritise and track status and progress through to implementation • Participate in the end-to-end Change Management process for Reporting Rules requests inclusive of CAB approvals, change owner tasks, writing & executing validation documentation and production of release notes • Provide operational direction and support for Global Safety Adverse Event intake channels (fax, e-mail, telephone etc.) across all global Amgen affiliates • Liaise with business to define requirements and internal IS functions on development, testing and implementation of Safety related enhancements for the Adverse Event Intake system • Provide International IS assistance to the Pharmacovigilance Legislation core team to assess technical impacts of new legislation on Safety systems and feedback into Global Safety IS team • Provide support to International Safety IS Business Partner as required in areas including representation at internal customer and cross functional IS Business Partner meetings, internal and external audits and inspections Basic Qualifications • Degree qualified in an IS related discipline or equivalent • Substantial relevant knowledge and experience gained in an IS environment Preferred Qualifications Knowledge: • Intimate knowledge and experience of Drug Safety systems and supporting business processes • Experience of analysing business requirements related to E2B and Reporting Rules • Data interfaces/file transfer, reporting and analysis skills • Documentation management • Knowledge of Unified Modeling Language • Network, infrastructure, operating system & web technology fundamentals • Software development lifecycle • Database & SQL fundamentals • Technical diagram/process flow charting • Entity relationships, use cases, design and concepts • Change control techniques • MS Office & MS Project fundamentals2012-02-24 19:33:07United KingdomAmgenNone13694BRNoneCambridge, GBR26739982http://www.amgen.jobs/xml/26739982/jobUSAThousand OaksAuto req 13086BR Job Posting Title Sr Scientist - Cell Sciences & Technology Career Category Process Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Cell Science and Technology department is recruiting a Senior Scientist level researcher within the cell line development and engineering functional area. The successful candidate will become a key member of a team focused upon the development of production cell lines for Amgen's large molecule biotherapeutic pipeline. The successful candidate will help direct lab personnel in both cell line and technology development programs. This team member will work towards the continued development of new, cutting-edge technologies to enhance outcomes and improve current scientific understanding, directed towards improving production cell line development and performance; with yield, speed, and efficiency in mind. The Senior Scientist will enhance and improve established platform approaches and utilize solid problem solving skills as well as out-of-the-box thinking to deliver technology improvements. Basic Qualifications - Doctorate degree & 2 years of scientific experience OR - Master’s degree & 8 years of scientific experience OR - Bachelor’s degree & 10 years of scientific experience Preferred Qualifications Candidates will require a solid scientific understanding of cell line development and associated technologies. Candidates will require strong mentoring capabilities, data driven decision-making and project management skills to help drive the team towards new performance levels. It is highly desirable that candidates with demonstrated independence, innovation, some previous bioprocess experience and a strong track record apply for this position. To be successful in this role, candidates should possess: - Ph.D. in molecular / cell biology or associated life science, combined with a minimum of 3+ years postdoctoral experience in a bioprocess development role or similar environment. - Strong molecular biology skills are essential together with expertise in mammalian cell culture, in particular stable cell line generation and clone screening. - Expertise in transcriptomics or similar ‘omics’ technologies and/or current gene knockout technologies highly advantageous. - Proven interdisciplinary project management skills - Ability to effectively mentor, motivate and manage more junior staff - previous FTE management experience essential - A track record in resolving and overcoming issues associated with the cell line development process and associated technologies - Recognized in the scientific community through a sustained record of publications and/or patents - Previous experience in the biotechnology/pharmaceutical required.2012-02-24 04:09:09United StatesAmgenCalifornia13086BRCAThousand Oaks, CA26721437http://www.amgen.jobs/xml/26721437/jobUSAWashington D.C.Auto req 14015BR Job Posting Title Reimbursement Exec Dir Career Category Government Affairs Employee Subgroup Executive FT Country (State/Region) United States - District of Columbia Location (City) Washington D.C. Amgen Job Description •The Executive Director, Medical Policy will serve as the lead on clinical matters in Amgen’s DC office and represent the function and company on clinical issues dealing with Federal (US) payers. •The Executive Director, Medical Policy will also work collaboratively with the US Health Policy & Reimbursement BU Leads, Global Health Economics, and the Global Government Affairs team to support the company’s Federal (US) coverage and reimbursement objectives. •The Executive Director, Medical Policy will work collaboratively across functions to ensure a comprehensive view of the business, policy, and health economics issues and create and maintain strong collaborative working relationships with key stakeholders. These stakeholders include colleagues in other Global Value & Access functions (including Global Health Economics), Global Government Affairs, the Business Units, and marketing, development, law, regulatory, and operations groups. •The Executive Director, Medical Policy will oversee and conduct relevant research and integrate clinical, market, and payer information to engage on coverage reimbursement objectives. •The Executive Director, Medical Policy reports to the Executive Director, U.S. Health Policy & Reimbursement. The position is based in the Washington, DC office. Basic Qualifications -Completed medical degree (M.D. or equivalent) -10 or more years of relevant professional experience (8 or more years of related professional experience for candidates with an additional Master, JD, PhD degree/equivalent in a relevant field of study, such as health policy, business, or similar discipline) -At least 8 years biotechnology/pharmaceutical industry reimbursement experience and/or government / commercial payer experience Preferred Qualifications •Strong understanding of Federal (US) payer environment, including areas of (1) approval, coverage, and reimbursement for both physician-administered and self-administered therapies and (2) health policy •Detailed understanding of Federal (US) Executive and Legislative branch health care policy and payment rate-setting authorities, processes, and responsible parties •Detailed understanding of Medicare and Medicaid statutes, regulations, and sub-regulatory policies related to coverage and reimbursement of health care products and services •In-depth experience in dealing with government payer programs and interacting with government program decision-makers •Ability to formulate health policy strategies that improve patient access to innovative therapies and implement these strategies to shape the external policy environment •Ability to review and summarize detailed clinical literature, including disease state information and target product profiles, in order to (1) understand and explain implications for payer actions and to (2) develop submissions for payer engagement •Strong project management skills with ability to work in a matrix environment •Excellent communication skills, including interpersonal skills to foster collaboration and oral/written presentation skills •Demonstrated success as a team leader •Direct government or payer experience and/or experience in product commercialization desirable •Previous experience in one of Amgen’s therapeutic areas of focus preferred2012-02-24 04:08:44United StatesAmgenDistrict Of Columbia14015BRDCWashington D.C., DC26721425http://www.amgen.jobs/xml/26721425/jobUSAThousand OaksAuto req 14014BR Job Posting Title Principal Scientist - Comparative Biology & Safety Sciences Career Category Preclinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen is seeking an experienced scientist to actively contribute in the drug development process from target selection and lead optimization through product registration. Working in a collaborative team environment with other colleagues in Research and Translational Sciences (e.g. therapeutic area scientists, drug metabolism, chemistry, protein sciences, early clinical development), the incumbent will contribute to the selection and safety assessment of small molecule and biologic therapeutics and represent Comparative Biology & Safety Sciences (CBSS) on drug development teams within Amgen. As a Principal Scientist in CBSS, you will design, implement, analyze and integrate a wide range of datasets from investigative studies and nonclinical safety assessment programs in support of drug development. Experience in resolving nonclinical safety issues through the establishment of novel protocols to solve experimental questions, in addition to devising strategies and planning activities to achieve project goals is required. An understanding of cutting-edge science and technology employed to enhance investigation of drug development safety liabilities is needed. You will participate and contribute to key project teams and provide regular updates as appropriate to senior management. Basic Qualifications Doctorate degree & 5 years of scientific experience OR Master’s degree & 12 years of scientific experience OR Bachelor’s degree & 15 years of scientific experience Preferred Qualifications A D.V.M., M.D. and/or a Ph.D in a biological science with expertise in a specific disease discipline, comparative medicine or pathology. A minimum of 5 years of industry or academic experience demonstrating a sustained record of achievement. Experience is needed to critically evaluate and interpret integrated sets of data from scientific experiments and then translate the potential clinical impact. Excellent verbal and written communication skills are necessary. Additional abilities expected include managing conflict, prioritization skills, resilience, and the demonstration of leadership through proactivity and influence, especially in a team environment. Post-doctoral research experience in toxicology, pathology or a disease specialty area. Board certification in toxicology or pathology. The preferred candidate will also have a working knowledge of computational and database tools for assessing multi-dimensional data and an ability to effectively query the literature and other public domain data repositories. The ability to work independently and to build productive cross-functional collaborations both internally and externally is also preferred.2012-02-22 20:28:59United StatesAmgenCalifornia14014BRCAThousand Oaks, CA26687824http://www.amgen.jobs/xml/26687824/jobUSAThousand OaksAuto req 14010BR Job Posting Title Post Doctoral Fellow - Protein Mass Spectrometry Career Category Process Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen Process & Product Development is seeking a postdoctoral fellow for developing and applying hydrogen/deuterium exchange (HDX) related technologies for protein product development. The duration of the fellowship is 2-3 years, with at least two years of commitment. The successful candidate will work with a cross-site team to develop mass spectrometry (MS)-based HDX methodologies for routine use, and apply these methodologies for product-development issues such as protein folding and aggregation. Primary responsibilities for this position include a) developing a robust and user-friendly LC/MS-based HDX platform for collecting and analyzing HDX-MS data; b) applying the platform for product development related issues such as conformation stability of different protein isomers, mechanism of protein aggregation, etc.; c) transferring the developed technologies to other Amgen labs; and d) exploring other HDX technologies such as FTIR, particularly data analysis tools. The project will include a collaboration effort and require travel to the other Amgen site in Seattle, WA. The candidate will write scientific articles about the developed technologies and their applications, as well as any significant discoveries from these technologies. The candidate should be experienced in protein mass spectrometry, and have excellent writing and communication skills. Basic Qualifications This position requires a PhD and experience in protein mass spectrometry. PhD must be awarded before the start of the post doctoral position. Preferred Qualifications Experience in MS-based HDX is preferred, and experience with protein FTIR or NMR is a plus.2012-02-22 20:27:33United StatesAmgenCalifornia14010BRCAThousand Oaks, CA26687723http://www.amgen.jobs/xml/26687723/jobUSAThousand OaksAuto req 13787BR Job Posting Title Sr Associate Scientist Career Category Process Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Seeking a highly motivated individual to function as a member of a commercial (drug product) process development team, focused on providing support to technology transfers, process characterization and commercial manufacturing. Position will perform experiments, organize data and analyze results with minimal supervision. Evaluation of product impact due to process variables will be a critical deliverables for this role. Understanding of degradation mechanisms for biologics, analytical methods, laboratory practices, and basic statistical methods is a need for this role. The position will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, and communicate data to the cross functional group. Experience with root cause analysis and technical investigations in the fill/finish area is a plus. Cross functional teamwork will be a critical component of this job. Regular interactions with Quality and Regulatory functions are expectations for this role. Effective communication skill is a requirement with the ability to exert influence a plus for this role. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmaceutical Sciences or related field. • 2+ years experience within the pharmaceutical/biotechnology industry; Experience to include understanding of physical / chemical stability of proteins, and interpreting results from various analytical methods on proteins. Process characterization, scale-up, and/or technology transfer experience. • Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality. • Familiarity with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing.2012-02-17 19:41:02United StatesAmgenCalifornia13787BRCAThousand Oaks, CA26597058http://www.amgen.jobs/xml/26597058/jobUSAThousand OaksAuto req 13954BR Job Posting Title Scientist Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the globe, Amgen fosters an inclusive environment of diverse, committed and highly accomplished people. People who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. We are currently seeking a Scientist for our Clinical Immunology group. This role will: • Design and execute specific scientific experiments for development, validation and implementation of methods capable of detecting anti-drug neutralizing antibodies or for measurement of drug biological activity in clinical and nonclinical study samples • Develop and implement new and novel protocols to address specific issues and/or troubleshoot and improve currently existing assays towards being more sensitive, transferable, and high-throughput • Conduct data analysis and interpretation, and assesses impact of the data on the project • Provide technical support and expertise to department operating groups when needed • Represent the department on cross-functional project teams • Provide scientific oversight to transfer of assays to CROs • Assist senior-level Scientists in managing clinical and/or non-clinical programs • Contribute as lead author on scientific documents such as journal publications, technical reports, etc. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience Preferred Qualifications A successful candidate in this role should: • Post doc experience preferred • Demonstrate innovation in cell signaling, in vitro assay design • Be able to solve complex problems demonstrating a deep understanding in a scientific area of expertise. • Demonstrate ability to drive scientific excellence and innovation. • Knowledge of the drug development process • Have the ability to effectively present scientific information both internally and externally to influence decisions and/or scientific practices • Demonstrate knowledge of the IND/NDA process • General knowledge of the field of Immunology, Oncology, Immunochemistry, or Cell Biology and pertinent immunologic assays. • Experience in in vitro cell-based assays and related technologies, in-depth knowledge of signal transduction processes. • Development, validation, transfer and implementation of assays detecting and characterizing antibodies to protein products in biological matrices and/or measuring drug activity. • Development, validation, transfer and implementation of fluorescence-based assays in cell lines, animal model and/or human specimens in collaboration with analysts and scientists in a variety of clinical / therapeutic areas. • Project Management as it pertains to oversight of vendors, assay transfers and implementation of outsourced assays. • Ability to communicate complex ideas to audiences with varying degrees of knowledge • Initiative • Attention to detail • Independence of thought demonstrated through hypothesis formulation, experimental design, interpretation and innovation • Demonstrated critical thinking with an ability to integrate data and information to solve complex problems • Ability to collaborate on a functional and/or cross-functional team as a leader and/or a member • Ability to build and manage a team2012-02-17 19:39:09United StatesAmgenCalifornia13954BRCAThousand Oaks, CA26597026http://www.amgen.jobs/xml/26597026/jobESPBarcelonaAuto req 13951BR Job Posting Title Value & Access Director Career Category Government Affairs Employee Subgroup Salaried FT Country (State/Region) Spain Location (City) Barcelona Amgen Job Description The candidate will be located in the affiliate of Amgen Spain (Barcelona), and reports to General Manager with dotted line to the Regional Access Head EU & AUZ. He/She will be a member of the Country Management Team. The candidate must oversee and coordinate the development and implementation of strategies to secure/maintain access at optimal prices for all Amgen in-market and launching products within the affiliate. Main Responsibilities: • Lead V&A team within the affiliate; sets direction for access planning and implementation, fosters collaboration with cross-functional partners, and mentors/supervises direct reports • Ensure close partnership with Governmental Affairs (GA) to develop optimal approach with governmental (both national and regional payers) • Achieve ACCESS: Anticipate together with GA environmental and policy changes; Collaborate proactively with payers and HTAs; Consider pricing strategies and creative alternatives; Evidence to demonstrate value; Shape together with GA the policy environment; Strategy development and flawless execution to ensure access goals are achieved • Anticipate the changing payer and policy landscape by closely monitoring national and regional pricing and HTA actions • In partnership with Affiliate GA proactively engage and collaborate with payers in strategic relationships. If appropriate, and in collaboration with the Regional Access team, engage with payers and HTAs in discussions of our pipeline evidence generation plans to gain feedback and to foster collaborative relationships • Engage with ICO Pricing and Contracting team to develop and implement local price policies and consider creative pricing strategies (e.g., risk-sharing; or conditional coverage schemes) if needed to secure access • Engage with Regional IHE team to generate the right value evidence—as expected by national and regional authorities—to effectively address threats to in-line molecules and demonstrate value of our pipeline products. Ensure that local HE team proactively partners with international and global HE function on critical value proposition elements (evidence, models, HTA submissions, training, etc.) • Shape the environment, in partnership with GA, by effectively engaging with key stakeholders (e.g., payers, policy makers, economic KOLs) • Partner with Regional team to drive development and implementation of affiliate access strategy across the portfolio o Integrate pricing and contracting, reimbursement and payer planning, health economics, and HTA and payment policy o Integrate product strategy, complementary added vale services and value proposition with affiliate price and reimbursement mechanisms to determine optimal access strategy with contingency plans into strategic plan o Articulate strategy and tactical plans into comprehensive plan for each product o Build realistic access and pricing assumptions into forecast o Leverage all available resources (e.g., clinical, regulatory, commercial, health economic, etc.) to develop and implement tactical plans and identify and overcome access barriers o Execute strategy and monitor progress to determine need for changes in strategy • Partner with Affiliate GA Head to define negotiation strategy and develop political stakeholder and government agency engagement plan depending on needs • Engage with Regional IHE Head and/or regional IHE Product Leads to ensure that affiliate needs for pipeline programs are appropriately incorporated and prioritized in planning international and global programs Basic Qualifications • University Degree and a complimentary MBA education will be a plus • At least 2 or 3 years of experience in a similar position and at least • Strong understanding of affiliate payer environment, including coverage and reimbursement, pricing and contracting, value drivers, formulary management, health technology assessment, HTA and payment policy • Demonstrated experience in access strategy development and implementation Preferred Qualifications • Accomplished team and business leader • Experience with direct payer engagement preferred, including established relationships with local decision makers and influencers. Concrete examples on implementing successful value proposition to payers will be valued. • Strong understanding of strategic pricing and contracting, including innovative approaches such as risk-sharing deals • Understanding of health policy preferred • Ability to review clinical and health economic literature, including disease state information, clinical trial design and results, and pharmacoeconomic studies in order to understand implications for value to payers2012-02-16 22:00:31SpainAmgenNone13951BRNoneBarcelona, ESP26576316http://www.amgen.jobs/xml/26576316/jobNLDBredaAuto req 13960BR Job Posting Title Specialist QA Career Category Quality Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Amgen Job Description Objectives Provides the QA oversight review and approval of validation strategies and documents Provides QA oversight review and approval of Packaging Engineering strategies and documents Position Specific Tasks Operational - Provide guidance for validation impact assessment for change control requests. Participate in ABR projects and improvement efforts. - Ensures that Quality policies, procedures and programs are properly implemented in daily Process Development operations and remain in compliance - Provide coaching, guidance and compliance direction to Facilities, Engineering , Maintenance and Process Development. - Work with other disciplines in developing requirements and strategies for large and/or highly complex process, system and facility modifications. - Develop solutions to complex validation problems requiring the use of ingenuity and creativity while maintaining compliant. - Work with project managers to complete the validation responsibilities of projects within schedule, budget and quality constraints. - Provide Quality oversight and approval for process development, engineering, validation projects and validation deliverables - Provide Quality oversight for good engineering practice documentation and system development. Process Maintenance: - Ensure Validation process at the site is maintained according to Corporate and GMP requirements and procedures reflecting process are in place and effective. - Integrate advanced validation engineering techniques ensuring alignment with industry standards. - Develop and provide Validation Training - Act as Validation contact in corporate and regulatory inspections, as needed. Basic Qualifications Minimum Requirements - Bachelor’s degree in Life Sciences or Engineering field or equivalent. - Typically 5+ years of related professional experience. OR - Master’s degree in Life Sciences or Engineering field or equivalent. - Typically 3+ years of related professional experience. OR - PhD in Life Sciences or Engineering field or equivalent. - Typically 1+ years of related professional experience. - Fluent in English. - Direct experience with regulated environment required. - Strong knowledge of GAMP, ASTM E2500, Annex 13, ICH Q7A, CFR 11, 210 and 211. Preferred Qualifications Preferred Requirements - Typically 10+ years of related industry experience in anufacturing and/or Quality Assurance. Strong knowledge of Good Distribution Practices.2012-02-16 21:59:39NetherlandsAmgenNone13960BRNoneBreda, NLD26576301http://www.amgen.jobs/xml/26576301/jobUSAThousand OaksAuto req 13873BR Job Posting Title Manufacturing Specialist - NPI/Packaging Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role will work within the New Product Introduction group of Amgen’s ATO Fill and Packing Organization and will be a key process leader in the introduction of new products within the Packaging department. The specialist will be a representative for ATO Packaging within the clinical commercialization program and serve as a key manufacturing operations liaison for new product introductions with an high degree of expected interaction with Quality, Planning, Engineering, Clinical Planning, Process Development, Global Operations teams, and other supportive and client groups. Additional responsibilities will include routine interaction with key quality and manufacturing systems, as well as with Operational Excellence (OE) initiatives, and global networks. Areas of scope and responsibilities include but are not limited to: • Supporting/Leading New Product Introductions (NPIs) • Ability to write, revise, and own manufacturing documentation (SOPs, Manufacturing Procedures, Device requirements (MPs), Forms) • Owner/lead author for Non-Conformances (NC’s), Corrective and Preventive Actions (CAPA’s), and Change Controls records that occur in association with the new product introduction process. • Work closely with Regulatory, Quality, and required accessors to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the new product introductions • Operational Excellence (OE) core team member who will champion OE initiatives, and facilitate the drive towards continuous improvement as it relates to new product introductions processes and shared opportunities with client and support groups • Work closely with Quality, Engineering, Process Development, Validation, and Operations to resolve project management issues in a timely manner • Assure appropriate escalation to various levels of management when timeline requirements for new product introduction are at risk or exceeded • Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams • Apply advanced process, operational, scientific expertise, compliance knowledge and analytical and troubleshooting skills to support manufacturing operations • Manage generation and presentation of key operating metrics for functional area • Provide training to manufacturing staff in support of new product introduction where appropriate Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelor’s degree & 5 years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) • Project management experience • Detailed technical understanding of packaging operations • Experience participating in and leading cross-functional teams • Experience in managing multiple, competing priorities in a fast-paced environment • Strong technical writing and verbal presentation skills • Ability to be flexible and manage change • Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms • Ability to communicate/manage upwards to high level stake holders (Director and above) • Highly detailed orientated • Exceptional organizational skill • Experience with a Current Good Manufacturing Practices (cGMP) • Experience with change control and non-conformance management systems/processes Preferred Qualifications: • Extensive technical knowledge of drug product packaging, drug product delivery devices, and a broad understanding of related disciplinary areas • Experience interacting with representatives of regulatory agencies • Detailed technical understanding of packaging operations • Strong experience with Microsoft Office suite - PowerPoint, Word, Outlook • Advanced Microsoft Excel experience in the management/analysis of data; including use of Excel Pivot Tables and advanced Excel chart management (formula statements, etc) • Strong experience with Microsoft SharePoint environment including the creation and management of Ninetex workflow • Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc. • Understands the core functional business processes and their role in Amgen's commercialization program2012-02-16 21:59:19United StatesAmgenCalifornia13873BRCAThousand Oaks, CA26576291http://www.amgen.jobs/xml/26576291/jobUSAThousand OaksAuto req 13564BR Job Posting Title Clinical Research Medical Director - Hematology / Oncology Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This Clinical Research Medical Director will work within the Hematology/Oncology Therapeutic Area. The responsibilities for this role include: - Supporting the development, execution and communication of the global scientific/medical evidence plan - Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program - Supporting the development of key scientific external relationships with opinion leaders - Participating and providing clinical input into safety and regulatory interactions Key Activities: - Provide clinical/scientific input during the development and execution of clinical trials - Interpret clinical trial data - Participate in safety assessments - Participate in interactions with regulatory agencies - Author CSRs, publications and regulatory submissions - Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL - Identify new clinical research opportunities - Support in-licensing and out-licensing activities and partner relationships - Support product lifecycle management for new indications as directed by Global Development Leader - Provide clinical content input to: - Regulatory interactions and documents - Safety interactions and documents - Materials to be used in Scientific Affairs - Materials to be used by the Commercial Organization Basic Qualifications - MD - Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Preferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent - Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities - Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) - Experience in clinical research in hematology and/or oncology2012-02-16 21:58:36United StatesAmgenCalifornia13564BRCAThousand Oaks, CA26576276http://www.amgen.jobs/xml/26576276/jobUSAThousand OaksAuto req 13963BR Job Posting Title Principal Scientist Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This is an exciting opportunity in the Early Development/ Molecular Sciences group at Amgen that could be situated in either the Seattle, WA or Thousand Oaks, CA campus for an individual to explore and apply pharmacodynamic and patient stratification biomarkers in the context of informing the decision-making process in drug development for cardiovascular therapeutics. The successful candidate will be responsible for leading and coordinating the biomarker effort for a portfolio of concurrent research and clinical projects. This responsibility would extend from efforts discovering and evaluating candidate biomarkers to overseeing the execution of biomarker assessments in clinical trials. The candidate will drive the implementation of biomarker strategy in clinical studies through close collaboration with discovery research, preclinical and early clinical development teams in the metabolism and general medicine areas. The candidate will also be responsible for organizing and contributing to the cross-functional and cross-site team interaction including meetings, reports and presentations. Basic Qualifications • Doctorate degree & 5 years of scientific experience OR • Master’s degree & 12 years of scientific experience OR • Bachelor’s degree & 15 years of scientific experience Preferred Qualifications •Ph.D in life sciences and 2+ years of post-doctoral experience and 4+ years of industry experience. •Experience in the discovery and implementation of biomarkers within clinical studies for cardiovascular disease (e.g. lipid regulation, dyslipidemia, atherosclerosis). •Strong desire to be part of the flexible and dynamic environment of early development, and be capable of supporting a broad portfolio of novel projects. •A strong background in cardiovascular biology, with emphasis on the understanding of pathway interventions applied as therapeutics. •Strong skills in critical thinking, laboratory experimentation and analysis, and understanding of the advantages and limitations of exploratory analyses in the clinical setting. •Effective communication and interpersonal skills and the ability to work in a matrix environment are essential.2012-02-15 22:00:25United StatesAmgenCalifornia13963BRCAThousand Oaks, CA26547305http://www.amgen.jobs/xml/26547305/jobUSAThousand OaksAuto req 13910BR Job Posting Title Medical Sciences Medical Dir - Oncology Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Medical Sciences Group is looking for a strong leader in Hematology/Oncology. The Medical Sciences leaders identify, organize, and execute early phase clinical and translational projects and substantially contribute to drug development. Throughout this continuum, they identify and manage external collaborators and consultants in completion of key projects. These experts represent Medical Sciences internally and externally, contributing intellectual insight into experimental design and data analysis. They typically serve as project leaders for at least one of Amgen’s Product Strategy Teams through their role as an Early Development Leader (EDL). This person filling this position must have demonstrated expertise in conducting translational and/or clinical oncology research, and will be the primary Medical Sciences contact for basic scientists studying hematologic and solid tumor malignancies as well as for clinical research scientists overseeing later clinical development. In addition, the candidate will have the following responsibilities: Serve as an internal clinical expert in translational and clinical oncology. Serve as medical monitor for clinical trials and assists in resolving major issues that may affect the studies. Present information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams. Coordinate clinical approaches to operational issues and assign monitoring and safety reporting resources. Provide guidance and assistance in the identification and management of oncology phase 1 collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects. Ensure appropriate training, recruitment, and development requirements for matrix team resources. Basic Qualifications •MD •Two(2)or more years of clinical research and/or basic science research experience Preferred Qualifications •MD plus accredited residency in Oncology and/or Malignant Hematology, board certified •MD/PhD and a strong basic science or clinical research background in academics or pharma •Effective presentation and communication abilities (both written and oral) •Ability to anticipate problems and find creative solutions •In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale •A record of high quality peer-reviewed publications •Experience functioning as a medical expert in a complex matrixed environment •Previous experience in early phase development and/or biomarker work is a strong plus2012-02-15 21:59:43United StatesAmgenCalifornia13910BRCAThousand Oaks, CA26547283http://www.amgen.jobs/xml/26547283/jobUSAThousand OaksAuto req 13888BR Job Posting Title Medical Sciences Medical Dir Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The candidate must be able to identify and organize preclinical and clinical scientific data in order to execute on early clinical studies that substantially contribute to early product development. Serve as a leader within Early Development (ED), with an interest and growing capability in representing the department on internal groups, such the ED protocol review committee. Identify and maintain relationships with key external collaborators. Contribute critical intellectual insights to strategy for generating decision-making, early clinical trial data. Collaborate in a team atmosphere, on interpretation and reporting of early clinical trial data. Responsible for responding to queries from regulatory agencies and participate in negotiations with these groups. The successful candidate will have the opportunity to lead late stage pre-clinical/early clinical Product Strategy Teams (PST) for Amgen’s early development pipeline. Basic Qualifications • MD • 3 years clinical trial experience in industry and/or academic setting Preferred Qualifications • Residency in Internal Medicine or related discipline • Subspecialty fellowship training in Clinical Pharmacology, or an Internal Medicine subspecialty, with a background in translational medicine • Experience interacting with or serving on an IRBs or Ethics Committees • Board certification or eligible • M.D./Ph.D. in biological science • Excellent oral and written communication skills • Excellent interpersonal skills • Experience in early clinical trials • Solid understanding of GCP and Healthcare Compliance • Experience in basic research and clinical trial methodology • Publication track record • Ability to lead, manage and motivate teams2012-02-14 20:00:48United StatesAmgenCalifornia13888BRCAThousand Oaks, CA26520634http://www.amgen.jobs/xml/26520634/jobDEUMunichAuto req 13952BR Job Posting Title Health Economics Senior Manager Career Category Health Economics Employee Subgroup Salaried FT Country (State/Region) Germany Location (City) Munich Amgen Job Description Insbesondere gegenüber gesundheitspolitischen Entscheidungsträgern spielen Sie eine bedeutende Rolle hinsichtlich der Vermarktung und Positionierung unserer Produkte und gewährleisten in Zusammenarbeit mit dem Value & Access- sowie unserem Medical-Team die kompetente und umsichtige Ausarbeitung unserer produktspezifischen Value Dossiers. Mit den nachfolgenden Verantwortlichkeiten unterstützen Sie maßgeblich die Erstattung unserer Produkte und deren Zugang zum Markt: - Eigenverantwortliche Erstellung von AMNOG-Dossiers/ Health Technology Assessments (HTA) in Anlehnung an unsere Global Value Dossiers sowie deren Einbindung in die lokalen Business Strategien in Anlehnung an die europäische Strategie - Entwicklung und lokale Adaptation der produktspezifischen „Value Proposition - Design und Durchführung von Beobachtungsstudien und Datenbankanalysen im Rahmen profunder Versorgungsforschungsprojekte, auch in Zusammenarbeit mit Kostenträgern - Entwicklung und Implementierung lokaler Health Economics-/HTA Kommunikations- und Publikationsstrategien in Anlehnung an unsere europäischen Pläne - Aktive Teilnahme an lokalen HEOR/HTA Workshops und Symposien mit Fach- und Wirtschaftsgremien sowie Ausschüssen im gesundheitspolitischen Bereich (Kooperation mit IQWiG) - Darstellung des wirtschaftlichen und klinischen Nutzens unserer Produkte bei den Entscheidungsträgern - Ausbau des Meinungsbildner-Netzwerkes im gesundheitspolitischen Umfeld - Lokale Adaptation gesundheitsökonomischer Modellierungen - Aktive Zusammenarbeit mit den europäischen Health Economics Kollegen und Arbeitsgruppen - Ansprechpartner für die Produktteams für alle Fragen bezüglich Health Economics, „Value Propositions und Erstattungsfragen - Erstellung und Durchführung interner Trainingsprogramme für den Bereich Gesundheitsökonomie Basic Qualifications - Abgeschlossenes Studium, idealerweise in Gesundheitsökonomie oder Medizin/Naturwissenschaften mit nachgewiesener profunder Zusatzqualifikation in Gesundheitsökonomie - Mehrjährige Berufserfahrung in der Pharmaindustrie, innerhalb des Krankenversicherungswesens oder gesundheitsökonomischen Beratungsfirmen - Fundierte Kenntnisse der Methodik gesundheitsökonomischer Modellierung, Design und Implementierung von Kosten-Effektivitätsstudien sowie von Krankheitskostenstudien - Kenntnisse und idealerweise Erfahrung in den Methoden der Erstellung systematischer Literaturreviews - Fundierte Kenntnisse der Methoden der Versorgungsforschung - Fundierte Kenntnisse der lokalen Erstattungsrichtlinien im Gesundheitswesen - Erfahrung in der Onkologie wie auch in der Nephrologie wären von Vorteil - Analytisches Denken, sicheres Einschätzungsvermögen des wirtschaftlichen und gesundheitspolitischen Geschäftsumfeldes und ein Gespür für daraus resultierende Entwicklungen und Marktchancen - Sehr gutes und sicheres Auftreten, Kommunikations- und Präsentationsfähigkeiten sowie Verhandlungsgeschick und Entscheidungsfreude, Überzeugungsfähigkeit und Ergebnisorientierung - Sehr gute Englischkenntnisse in Wort und Schrift - Sicherer Umgang mit MS-Office, insbes. Excel, Kenntnisse in Modellierungssoftware (z.B. TreeAge) sind von Vorteil - Reisebereitschaft Preferred Qualifications Was wir Ihnen bieten: - Die Möglichkeit, Ihre Karriere bei einem der innovativsten und erfolgreichsten Unternehmen der Branche zu gestalten - Die Entwicklung Ihrer fachlich-professionellen Fähigkeiten sowie Ihrer persönlichen und sozialen Kompetenzen - Ein durch Offenheit und Erfolgsorientierung geprägtes Arbeitsumfeld - Attraktive Vertragsbedingungen und Sozialleistungen Möchten Sie sich bewerben? Dann laden wir Sie als zukunftsweisendes, innovatives Unternehmen herzlich auf unser Karriere-Portal unter www.amgen.de ein. Wir bitten Sie, sich dort entsprechend zu registrieren und uns Ihre Bewerbung (auf o.g. Requisiton-Nr. 13952BR) online zu übermitteln. Selbstverständlich bewahren wir alle datenschutzrechtlichen Bestimmungen. Für Fragen vorab steht Ihnen Frau Martina Rech (Staffing Manager) gerne unter der Telefonnummer (089) 14 90 96-1112 zur Verfügung.2012-02-14 19:52:24GermanyAmgenNone13952BRNoneMunich, DEU26520420http://www.amgen.jobs/xml/26520420/jobIRLDublinAuto req 13864BR Job Posting Title HVAC & Utilities Validation Engineer Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Job Title HVAC/Utilities Validation Engineer Job Description HVAC/Utilities Validation Engineer As a HVAC/Utilities validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the HVAC/Utilities for a Sterile Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards. Major Responsibilities • Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for HVAC and Utilities for a Sterile Fill Finish Facility. • Ensure all aspects of HVAC/Clean Utility Validation adhere to required policies and procedures, including safety and training. • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. • Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures. • Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for HVAC, Clean Steam, Process Air and WFI Systems. • Participate as required in project activities. • Review of Existing Site Systems to ensure compliance. • Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed. • Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents • Collate and report on relevant Validation data/matrices. • Assist in deviation and exception resolution and root cause analysis. • Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader. • Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant. Basic Qualifications Experience/Background • A third level qualification in Science, Engineering or a relevant Quality discipline. • Minimum 4-6 years experience in a similar role. Education Requirements • A third level qualification in Science, Engineering or a relevant Quality discipline.2012-02-13 19:30:14IrelandAmgenNone13864BRNoneDublin, IRL26495641http://www.amgen.jobs/xml/26495641/jobIRLDublinAuto req 13863BR Job Posting Title Sterile Filling & Inspection Validation Engineer Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Job Title Sterile Filling and Inspection Validation Engineer Job Description Sterile Filling and Inspection Validation Engineer As a Sterile Filling and Inspction validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the Sterile Syringe Filling and Inspection for a Sterile Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards. Major Responsibilities • Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Sterile Syringe Filling, Isolator and Inspection for a Sterile Fill Finish Facility. • Ensure all aspects of Syringe Filling, Isolator and Inspection Validation adhere to required policies and procedures, including safety and training. • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. • Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for Syringe Filling, Isolator and Inspection Systems. • Participate as required in project activities. • Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed. • Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents • Collate and report on relevant Validation data/matrices. • Assist in deviation and exception resolution and root cause analysis. • Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader. Basic Qualifications Experience/Background • A third level qualification in Science, Engineering or a relevant Quality discipline. Syringe Filling and Isolator Technology Experience essential Automated Inspection Technology Experience an advantage • Minimum 4-6 years experience in a similar role. Education Requirements • A third level qualification in Science, Engineering or a relevant Quality discipline.2012-02-13 19:30:03IrelandAmgenNone13863BRNoneDublin, IRL26495637http://www.amgen.jobs/xml/26495637/jobIRLDublinAuto req 13867BR Job Posting Title Sr Packaging Validation Engineer Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Job Title Senior Packaging Validation Engineer Job Description Senior Packaging Validation Engineer As a senior Packaging validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the Packaging and Labelling and Shipping of Sterile Filled Syringes and Vials are in compliance with Division Quality System requirements and recognised international standards. Major Responsibilities • Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Vial and Syringe Packaging for a large scale packaging operations. • Leading the team to ensure all aspects of activity within the Packaging Validation adhere to required policies and procedures, including safety and training. • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. • Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures. • Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective. • Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed. • Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents • Collate and report on relevant Validation data/matrices. • Assist in deviation and exception resolution and root cause analysis. • Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader. • Participate as required in project activities. • Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant. Basic Qualifications Experience/Background • A third level qualification in Science, Engineering or a relevant Quality discipline. • Minimum 5-10 years experience in a similar role. Preferred Qualifications Overall knowledge in equipment, facility, cleaning and steaming validation. Technical understanding of pharmaceutical/biotechnology unit operations. Project management skills Skilled at initiation and leading cross functional teams Database and spreadsheet application skills Strong technical writing and oral communication skills Facilitation and presentation skills Experience with leading complex investigations and CAPAs Ability to evaluate compliance issues and interact with regulatory inspectors2012-02-13 19:29:10IrelandAmgenNone13867BRNoneDublin, IRL26495601http://www.amgen.jobs/xml/26495601/jobUSAThousand OaksAuto req 13841BR Job Posting Title Exec Dir Regulatory Affairs - Bone TA Career Category Regulatory Employee Subgroup Executive FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role leads the Bone Therapeutic Area team within Amgen's Regulatory Affairs department. The Therapeutic Area Head (TAH) manages a team responsible for developing and executing regulatory strategies and managing effective regulatory agency interactions to achieve desired regional labeling and global registration. The TA Head will represent Global Regulatory Affairs as a member of the Therapeutic Area Steering Committee (TASC) within the Amgen Commercialization Process in addition to providing high-level strategic guidance to Global Regulatory Leaders. Key Activities: • Consult with Global Regulatory Leaders (GRL) in development of global regulatory strategies and approve Global Regulatory Plan and Global Strategic Plan • Global oversight of all regulatory aspects between and across products within a therapeutic area • In collaboration with Amgen regional staff, interact and negotiate with key regulatory agency officials in the execution of Global Strategic Plans • Oversee core regulatory and cross-functional teams to ensure effective agency interactions • Provide technical expertise in inspections, negotiate the need for inspections, review responses to observations • Provide input to TASC, senior management review committees, governance boards, other cross-functional product meetings • Provide guidance to team on regulatory strategies, precedence and risk management • Consult and review contingency planning/risk assessment for products within a therapeutic area development strategies and agency interactions • Monitor, assess and communicate impact of relevant global regulations, guidance’s current regulatory environment and competitor labeling • Assist corporate training on regulatory affairs and contribute to the design and content development of department training programs • Provide coaching, mentoring, and development of staff Basic Qualifications • Doctorate degree and 6 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies OR • Master’s degree and 10 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies OR • Bachelor’s degree and 12 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies AND • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources Preferred Qualifications • Advanced degree • Regulatory submissions experience specific to bone products • Experience interacting with senior regulatory agency representatives Knowledge and Skills leveraged in the role: • Strong communication skills – both oral and written • Ability to understand and communicate scientific/clinical information • Demonstrated ability to lead teams2012-02-11 19:45:48United StatesAmgenCalifornia13841BRCAThousand Oaks, CA26476662http://www.amgen.jobs/xml/26476662/jobUSAThousand OaksAuto req 13890BR Job Posting Title Principal Scientist - PKDM Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen is seeking a highly motivated and team-oriented candidate for the position of Principal Scientist in the Quantitative Pharmacology Group of PKDM Department. The Principal Scientist will serve as a PK/PD expert and Pharmacometrican to support Amgen Development and Discovery programs in the Oncology Therapeutic Area. The successful candidate will implement advanced modeling & simulation (M&S) strategy, develop M&S cutting edge methodology, and work collaboratively with cross-functional teams to optimize PK/PD study design and study protocol. He/she will be responsible for hands-on PK/PD analyses, modeling & simulations, report writing, and the preparation and maintenance of Investigator Brochures, IND/IMPD/CTX/RTQ/CTD, and other summary documents for regulatory submissions. He/she may transition into the role of PKDM Development Project Team Representative and independently represent the function area when appropriate. Development of junior members and interaction with the line-management will also be key responsibilities. Basic Qualifications •Doctorate degree & 5 years of scientific experience OR •Master’s degree & 12 years of scientific experience OR •Bachelor’s degree & 15 years of scientific experience Preferred Qualifications •PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 7+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training •Specialized in PK/PD modeling and population-based analyses/simulations with established track-record records of model-based drug development •Experience in supporting preclinical/clinical PK, PK/PD, and modeling & simulation components of regulatory documentations. •Leadership quality for effective team building with strong decision making and problem solving skills •Excellent interpersonal, technical, and communication skills to lead cross-functional teams •Candidate with R&D experience to support small and/or large molecule oncology therapeutics •Demonstrated experience with modeling and simulation software (e.g. NONMEM, SAS, S-Plus, Pharsight Clinical Trial Simulator) •Excellence and eminence in field of PK/PD and modeling & simulation with peer-review articles and external presentations.2012-02-10 18:17:40United StatesAmgenCalifornia13890BRCAThousand Oaks, CA26456588http://www.amgen.jobs/xml/26456588/jobUSABoulderAuto req 13823BR Job Posting Title Sr Engineer - Mfg Projects Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - Colorado Location (City) Boulder Amgen Job Description Amgen Colorado’s Engineering team is responsible for delivering capital and expense improvement projects to our client’s business needs. We target small to moderate sized projects located within operating business units. We feature staff with diverse engineering backgrounds with intimate knowledge of operations and working in GMP environments. We minimize impact to client operations due to excellent planning, coordination, and controls. The Sr. Engineer is responsible for engineering design, implementation, construction support, technical execution and commissioning for multiple capital and expense projects at Amgen Colorado. This involves preparation of engineering studies, conceptual design alternatives, schematic and design details, and commissioning protocols. • Supports the project team during engineering studies geared toward developing the technical and business justification for engineering projects. • Work with clients and stakeholders from manufacturing, process development, facilities, quality assurance and validation to develop and define user requirements. • Responsible for identifying and refining design alternatives during conceptual schematic design evaluations. • Responsible for executing and/or directing, coordinating and supervising the work of consultants and engineering firms during the schematic and detailed design phases. • Executes and/or directs technical resources during the implementation phase (includes construction, startup, commissioning, and validation). • Responsible for turnover packages prepared during the detailed design phase and project close out. • Responsible in ensuring that all Amgen standards and procedures are followed by the project team. • Verifies that all change control procedures are properly documented. • Works closely with other discipline and/or project engineers to coordinate the design and implementation. • May work in as a discipline or project engineer depending on the needs of each project. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelor degree in Engineering and 8+ years of related engineering experience with four of those years engaged in projects in a manufacturing environment. Demonstrated understanding of project life cycle, versatility, adaptability, decision making skills, collaboration, accountability, problem solving skills, teamwork, and quality control on engineering projects. Position requires excellent technical writing and verbal communication skills. Demonstrated track record of being science-based, competing intensely and winning, creating value for patients, staff and stockholders, being ethical, trusting and respecting each other, working in teams, ensuring quality, and collaborating, communicating, and being accountable. ? Experience with design and implementation in a manufacturing environment, and with validation and change control methodology strongly desired. ? Knowledge and skills in Microbial and Mammalian Fermentation, Cell Culture and Purification systems strongly desired. ? Demonstrated leadership experience ? Project management experience ? Technology transfer experience ? Knowledge of cGMP pharmaceutical manufacturing process design requirements. ? High level experience with design, programming, and commissioning activities for all automation/process systems and controllers (such as SLC, PLC, DeltaV, BMS, HMI & SCADA). ? Ability to review and approve engineering documentation such as requirements and design documents, I/O diagrams, one-line diagrams, panel layout diagrams, system architecture diagrams, and instrument data sheets.2012-02-10 18:16:30United StatesAmgenColorado13823BRCOBoulder, CO26456571http://www.amgen.jobs/xml/26456571/jobTURField BasedAuto req 13899BR Job Posting Title Sr Biopharmaceutical Rep Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) Turkey Location (City) Field Based Amgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications2012-02-09 23:45:03TurkeyAmgenNone13899BRNoneField Based, TUR26445021http://www.amgen.jobs/xml/26445021/jobUSAThousand OaksAuto req 13870BR Job Posting Title Clinical Research Medical Director - Oncology - Xgeva Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This Clinical Research Medical Director is responsible for: - Supporting the development, execution and communication of the global scientific/medical evidence plan - Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program - Supporting the development of key scientific external relationships with opinion leaders - Participating and providing clinical input into safety and regulatory interactions Key Activities: - Provide clinical/scientific input during the development and execution of clinical trials - Interpret clinical trial data - Participate in safety assessments - Participate in interactions with regulatory agencies - Author CSRs, publications and regulatory submissions - Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL - Identify new clinical research opportunities - Support in-licensing and out-licensing activities and partner relationships - Support product lifecycle management for new indications as directed by Global Development Leader - Provide clinical content input to: - Regulatory interactions and documents - Safety interactions and documents - Materials to be used in Scientific Affairs - Materials to be used by the Commercial Organization Basic Qualifications - MD - Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Preferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent - Experience in GU Oncology - Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities - Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) - prior oncology clinical research / experience Knowledge - In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale - Familiarity with concepts of clinical research and clinical trial design, including biostatistics - Sound scientific and clinical judgment - Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements - Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication - Demonstrated ability as a medical expert in a complex matrix environment - History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues2012-02-09 23:44:48United StatesAmgenCalifornia13870BRCAThousand Oaks, CA26445010http://www.amgen.jobs/xml/26445010/jobITAMilanAuto req 13284BR Job Posting Title Strategic Sourcing Sr Manager Italy – Productivity Lead Career Category Supply Chain Employee Subgroup Salaried FT Country (State/Region) Italy Location (City) Milan Amgen Job Description Reporting to the Affiliate Finance Director and Director Strategic Sourcing, the person will be responsible in the Italian affiliate for: - Secure the availability of goods and services in strict and consistent compliance with Amgen’s requirements at minimum total cost and risk and as to local F&A. - Ensure effective management of local strategy development, selection and contracting processes, supply base control and performance and the operational purchasing process to the International Procurement Director: - Ensure an effective and efficient local Sourcing and Supplier management process in accordance with established Procurement policies and guidelines - Ensure early procurement involvement in sourcing projects The main activities will be: Local, ad-hoc sourcing: Opportunity identification: identify local improvement opportunities with respect to management of Purchase demand, Supply base and Total Cost on a local level Requirements definition: identify and define specific stakeholder requirements; Tendering: define evaluation/selection criteria, define and manage RFI and RFP processes on the basis of the local sourcing strategy, derived from the category sourcing strategy; Supplier Selection: evaluate and negotiate proposals, ensure and validate selection of the best supplier; Supplier Contracting: complete and implement the contract in accordance with legal standards and Procurement policies and guidelines; Category management: Supply base analysis: monitor, analyze and report Affiliate’s actual spend, trends, forecasts and Supplier base data; Strategy development: participate in International category strategy development European Sourcing: participate in International Sourcing teams Infrastructure development: support Strategic Sourcing infrastructure development and integration. Purchase to pay: Purchase to pay: assist and monitor the operational purchase to pay process for the Affiliate concerned and ensure conformance to procurement process policies and guidelines Supplier performance: Performance Monitoring: monitor and report supplier performance on the basis of pre-determined, relevant and measurable KPIs Supplier performance improvement: establish, agree and implement improvement plans. Reporting: Benefits tracking: develop, maintain and report Key Performance Indicators that clearly reflect the achievement of objectives in each business area Basic Qualifications - Indirect Purchasing knowledge: sourcing process, commodity management and analysis, supplier management and development, pricing theory and policy, negotiation, supply chain, make or buy. BSc/HBO (technical/economic/administrative) or equivalent - Purchasing related training (Nevi, Isfah, CIPS, MBA) - Negotiation (at least 1 course) - At least 5 years Purchasing experience in a profit driven and international environment (Project) Management experience (team or direct) - Experience with tendering processes, supplier negotiations and contracting, including eSourcing - Experience with ERP - Computer skills (MS-office environment)and master user in Excel - Willingness to travel - Fluency in English and Italian, both in oral and written communication Preferred Qualifications - Business process related training - At least 5 years Business Process related experience in a Pharmaceutical or similar environment - Fluency in multiple languages - Skills and knowledge in Finance2012-02-08 20:05:02ItalyAmgenNone13284BRNoneMilan, ITA26410392http://www.amgen.jobs/xml/26410392/jobTURIstanbulAuto req 13648BR Job Posting Title Sr Biopharmaceutical Rep Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) Turkey Location (City) Istanbul Amgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications2012-02-08 20:03:54TurkeyAmgenNone13648BRNoneIstanbul, TUR26410312http://www.amgen.jobs/xml/26410312/jobUSAThousand OaksAuto req 13541BR Job Posting Title Sr Associate IS Bus Sys Analyst (Web) Career Category Information Systems Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role is primarily responsible for working closely with internal Amgen clients, client-facing IS groups, external vendors, and IS partners to oversee & assist development of external websites and associated solutions leveraging the J2EE/.NET stacks that may or may not leverage an underlying Content Management System. Responsibilities include client engagement, monitoring emerging client needs/industry developments, requirements elicitation, process and systems analysis, identification of new capabilities/tools/automation solutions and approaches for addressing business needs, propose changes to existing service components, define standards/guidelines/processes for external website development, and supporting the development of business cases for proposed solutions. Basic Qualifications Master’s degree OR Bachelor’s degree & 2 years of directly related experience OR Associate’s degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience Preferred Qualifications • Web development experience in J2EE, .NET stacks • Ability to use a Content Management System to deploy/manage website content • Strong web site and page design and layout skills • Web usability • Information Architecture development skills • Search Engine Optimization • Web metrics reporting • Integration with Web Metric solutions • Unit and Integration testing • Implement website security • System analysis, integration • Ability to work with diverse teams • Vendor management • Technical Writing • Process development • Comfortable giving presentations to client groups • Ability to effectively manage client relationships • Ability to quickly adapt to changes in client needs and reformulate plans accordingly • Strong organizational and work planning skills are needed • Competent at using Microsoft Office technologies. • Knowledge in areas: o Information Architecture o Portals & Collaboration Tools o Iterative Development o Formalized Requirements Gathering o Experience with LDAP, VPNs and ASP services also a plus o Development of policies, SOPs and associated documents o Internet protocols including: TCP/IP and HTTP and Web technologies. Strong business analysis skills are required in order to work with client organizations, understand/gather their requirements, lead functional requirements discussions, provide subject matter expertise and authority in defining use or no-use of tools and techniques, and develop/oversee development of solutions. Seeking forward looking candidates who are comfortable with a fast paced service and are able to bring innovation and thought leadership in implementation of technology solutions and tools to meet client and the service’s needs. Successful candidates will possess strong skills in developing test case documentation and have demonstrated the ability to coordinate, lead and document formal testing of IT systems. Excellent documentation and writing skills are key. The ability to document and communicate processes and follow accepted Amgen IS policies and standards is mandatory. The successful candidate will establish and maintain a positive business relationship with managers, staff, and external business partners that utilize the COE’s services. He or she will demonstrate a thorough ability to obtain understanding of the functional area business models, processes, and priorities, and leverage that knowledge in the delivery of production solutions to meet client automation needs. Candidates must be able to work independently and provide recommendations on strategies for meeting client needs within the scope of the COE’s service offerings. He or she should have the ability to see the big picture and zoom-into specific areas as and when needed.2012-02-08 02:39:37United StatesAmgenCalifornia13541BRCAThousand Oaks, CA26389652http://www.amgen.jobs/xml/26389652/jobUSAWashington D.C.Auto req 13703BR Job Posting Title Admin Coordinator - Washington, DC Career Category Administrative Employee Subgroup Hourly FT Country (State/Region) United States - District of Columbia Location (City) Washington D.C. Amgen Job Description The Administrative Coordinator (AC) will be primarily responsible for complex administrative support activities, supporting multiple Executive Directors/Directors/Sr Managers in the Global Government Affairs organization. Key Activities: •Initiating/facilitating/participating in cross-functional team meetings •Independently coordinating web-interface meetings •Developing slide presentations. •Scheduling interviews •Assisting with special projects as requested by the Directors and others within group. • Screen and act on incoming phone calls • Maintain distribution, contact and personnel lists • Coordinate mailings and courier/deliveries • Coordinate functional processes such as invoicing and payments • Manage the administrative aspects of relationships with outside experts and vendors • Participate in department project teams • Provide backup support to additional department ACs • Update and maintain all dues, memberships, subscriptions etc. This role will leverage an experienced AC who enjoys working in a fast-paced environment, and can ensure timely coordination of the department members’ below listed administrative needs. • Manage individual and team calendars (Outlook) • Coordinate local and international meetings: arrange travel, meeting arrangements, visitor accommodations • Organize meeting rooms, including logistics, catering and equipment needs • Prepare agendas and take action items as required. This role will require the incumbent to be flexible, take initiative and work well independently and in teams. This role will proactively anticipate needs, communicate expectations, disseminate and compile information. This role will leverage an individual who is detail-oriented, able to work on multiple projects simultaneously and organize and prioritize workflow. This role will require the individual to be able to handle sensitive and confidential information with diplomacy and discretion. The individual will need to take a proactive approach to identifying breakdowns in service, information flow and process, and resolve issues appropriately. This role will act as a liaison to internal department staff, cross-departmental areas, and external contacts for those individuals. This role will be called upon to interact with various levels of Amgen management and external clients. This role will call upon excellent interpersonal skills and be able to positively influence others. In order to be successful in this role the incumbent will need to be able to effectively communicate, both orally and in writing, with internal staff, supporting functional units. Modifying communication style as appropriate for the varied audience will be important. This role will be able to, with minimal direction, anticipate next steps, identify issues/problems and propose solutions. Will also demonstrate a service-oriented approach to all activities, a willingness to learn new approaches and adapt to change, and will lead by example in promoting teamwork. Basic Qualifications • Associate’s degree & 2 years of directly related experience OR • High School diploma / GED & 4 years of directly related experience Preferred Qualifications Amgen experience -5+ years of experience in an administrative support role supporting large teams at different levels -Managing multiple calendars including coordination across multiple time zones •Excellent written , verbal, and presentation skills in communicating key business and clinical information •Advanced knowledge of MS Excel, PowerPoint, and Word (i.e. word processing, presentations, and spreadsheet skills) as well as Cognos, Sharepoint, and the Learning Management System at Amgen •Experience providing administrative support to remote staff •Outstanding organizational and interpersonal skills •Ability to work in a fast-paced ,deadline- driven environment •Discretion in dealing with proprietary information2012-02-08 02:39:01United StatesAmgenDistrict Of Columbia13703BRDCWashington D.C., DC26389649http://www.amgen.jobs/xml/26389649/jobUSASeattleAuto req 13373BR Job Posting Title Scientist - Biotech Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - Washington Location (City) Seattle Amgen Job Description A Scientist would be expected to act as a lead technical support for a pre-commercial drug product program within process development to achieve the resolution of technical issues, to author technical documents and support all technical issues around commercialization of the drug product. Support of technology transfer and site selection, equipment selection, process design, validation strategy, and relevant GMP documentation is also required. The scientist applies fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve processing issues and develop a robust commercial product, as well as evaluating changes such as process improvements, equipment, scale, and raw materials Participate as author for process transfer documentation, technical reports, batch records, GMP documentation and regulatory filings. Travel will be required. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or Life Sciences. 4+ years of relevant biotech experience in process development within a pharmaceutical or biotechnology corporation. Ability to apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to develop the drug product process, troubleshoot manufacturing operations, evaluate equipment design, and scale up the drug product process. Experience with process development for biologics including lyophilization cycle development. Experience participating in global, cross-functional teams working on technology transfer of biologics.2012-02-08 02:38:38United StatesAmgenWashington13373BRWASeattle, WA26389646http://www.amgen.jobs/xml/26389646/jobUSAThousand OaksAuto req 13751BR Job Posting Title Specialist IS Business Systems Analyst (IS Technical Lead / Developer Service-Now) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position will be part of the Technology Services team within the Integrated Service Management function, and will be responsible for providing application and development maintenance and administration support for the Integrated Service Management tool (ISM) This position will be a Developer/Administrator for Service-Now Application and will work as a member of the support team to configure and maintain the Service Management tool. This position will provide technical assistance, workflow development, and software configuration/customization. This may include but not limited to: custom reports, data imports, LDAP integration, custom scripting and third party software integrations. Responsible for the design and development of ITIL tool. Develops design and functional specifications, produces deliverables related to changes or enhancements with the tool. Responsible for Java Scripting and Configuration of tool. May be responsible for gathering, compiling and synthesizing information with regard to technology processes or systems. Includes documenting requirements, design, and producing and executing positive and negative test scripts. Responsibilities will include: - Providing software customization assistance including, but not limited to: screen tailoring, workflow administration, report setup, data imports, LDAP integration, custom scripting and third party software integrations - Answering how to” technical and application configuration questions - Facilitating roll out of new applications and modules - Assisting in troubleshooting patch / release management issues - Aiding in translating business requirements into technical requirements - Helping to implement new functionality including configuration and testing - Writing Custom Reports - Writing application documentation - Implementing new requirements - Maintaining validation and training documentation This position will be expected to develop recommendations and lead the implementation of improvements in documented practices and reports. Basic Qualifications - Doctorate degree OR - Master’s degree & 3 years of directly related experience OR - Bachelor’s degree & 5 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - Bachelor's degree in Computer Science or related field - Proven skills in Windows Administration and Java Scripting - ITIL tool experience - Experience in all aspects of SDLC from requirements, design, testing, and support - Demonstrated skills in Web Technologies or web-based scripting technology (XML, HTML, JAVA Script, AJAX, CSS, HTTP, SOAP etc.) - Web applications, networks, protocols and email (SMTP, POP3) - The ability to take complex end-user requirements to system requirements to code - Understanding of enterprise IT architecture - Working knowledge of relational databases - Basic understanding of ITIL v3 methodologies Experience in these areas is also preferred: - Web Services integrations - Experience with Service-Now.com configuration or implementation - Experience configuring other SaaS solutions such as Salesforce.com a plus - ITIL Certification - CMDB design and usage experience - Web Services integrations and experience with web services via APIs - Experience with IT Service Management, Service Desk, Asset Management and Change Management - Knowledge of LDAP - Active Directory, eDirectory, OpenLDAP; Discovery Tools; Single Sign-on using: Digested Token, SAML 1.1, SAML 2.0. - Experience in implementing, monitoring, analyzing and supporting IS service management processes/tool - Regulatory processes and controls experience, excellent documentation The following attributes and abilities are also highly preferred: - Self-motivated, a positive can-do attitude & willingness to learn, forward thinking, assertive, and able to focus on finding and developing unique opportunities to create value by enabling and engaging in creative dialogue with various key stakeholders - The ability to work independently and with a team - Strong business analysis, data analysis, and problem analysis skills - Able to organize and schedule tasks, develop realistic action plans incorporating time constraints and task priorities. - Demonstrated ability to successfully negotiate with clients - Strong analytical, leadership, and project management skills as well as strong personal commitment to quality service - Strong presentation skills, interpersonal skills, verbal and written communications skills2012-02-02 01:06:29United StatesAmgenCalifornia13751BRCAThousand Oaks, CA26261227http://www.amgen.jobs/xml/26261227/jobUSASouth San FranciscoAuto req 13691BR Job Posting Title Sr Counsel - Biotech (Large Molecule) Career Category Law/Legal Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Thousand Oaks Amgen Job Description Position may be based in our Thousand Oaks, CA or San Francisco, CA locations. This role will be involved in patent application drafting and prosecution, research and licensing agreements, legal opinions and strategies, trademark and copyright matters, and potentially patent litigation support. The role will be responsible for identifying patentable subject matter; drafting, filing and prosecuting patent applications; developing legal strategies relating to products and product candidates; analyzing patents and preparing infringement, validity and freedom-to-operate opinions; conducting due diligence in support of licensing activities; negotiate and draft research agreements; and provide advice and counsel to R&D and business personnel on a variety of IP related matters. Will work individually and in legal teams and cross-functional R&D and business teams. Basic Qualifications - JD degree from an accredited law school and admission to practice law required - 4 Years of experience practicing patent or intellectual property law Preferred Qualifications - 10 plus years of experience preferred Experience in all aspects of U.S. and foreign intellectual property law relating to biotechnology, preferably in the pharmaceutical industry with a law firm or corporation. - An advanced degree or experience in biology is considered a plus. - Excellent analytic, legal drafting and oral and written communication skills. - Strong management and leadership skills as well as a strong client service focus and the ability to work independently and in teams, efficiently, prioritize workflow, meet demanding deadlines, and manage multi-dimensional projects in a fast-paced environment.2012-02-01 02:26:51United StatesAmgenCalifornia13691BRCASouth San Francisco, CA26231381http://www.amgen.jobs/xml/26231381/jobGBRCambridgeAuto req 13453BR Job Posting Title Medical Development Sr Mgr Career Category Medical Affairs Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Amgen Job Description Overview: The Oncology TA lead leads a high-performing office and field-based team, providing medical expertise across the organization to generate strategies, clinical data, analysis and communications that support the safe and effective use of our medicines by patients, physicians and payers . Key responsibilities • Set UK/Ireland goals and dashboards to evaluate performance, approving TA plans, goals, proposals and deliverables • Be the single point of accountability for all UK/Ireland TA activities ensuring alignment of early-stage strategy with late-stage TA objectives • Drive the data generation, establishing and communicating the strategy for the UK/Ireland TA • Manage resources, budgets and forecast accuracy within area of responsibility ensuring adequate resources and budget across all programs (study and non-study) and maintain budget accountability. • Assist the Medical Lead in identifying and resolving clinical/scientific issues and direct UK/Ireland Medical Advisors in navigating products through internal governance and external regulatory portals • Assist UK/Ireland Medical Advisors in interactions and communication with external customers, key organizations, and institutions • Assess risk and identifying issues, conflicts or gaps (Affiliate/Sub-Regional) across the portfolio • Perform portfolio level risk assessments and prioritization of programs • Chair Affiliate/Sub-Regional TA Team meeting and the Local Development Team (LDT) • Serve as a key interface to communicate Internationally and locally important issues and status of programs to Amgen IRD and UK/Ireland Management • Foster and improve International collaboration and coordination • Partner with the UK/Ireland Business Unit for all product lifecycle management activities • Provide input, review, approve the UK/Ireland lifecycle management plan and ensure alignment across the portfolio • Provide scientific/clinical oversight for the compilation of regulatory submissions across the portfolio • Provide clinical oversight of product safety evaluation within the Affiliate/Sub-Regional TA • Provide support and leadership for advisory boards Basic Qualifications • Medical Degree (MD) • Extensive experience in designing and managing clinical trials across different phases of development, in providing advice to Medical Advisor within country/ region and resolving clinical trial-related issues • Substantial experience gained in a pharmaceutical or biotechnology company • Broad and formal leadership experience Preferred Qualifications • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale • In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials • Medical knowledge in the relevant therapeutic area • Sound scientific and clinical judgment • Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups • Knowledge of Good Clinical Practices (GCP), EMEA regulations and guidelines, and applicable international regulatory requirements • Understanding of new drug commercialization and business practices • Understanding of resourcing and budgeting • Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication • Demonstrated ability to organize and lead expert Medical Advisory Panels • History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues • Track record in effectively managing risk and compliance • Building strong relationships with KOLs within DA • Coaching and mentoring Medical Advisor within a Medical Department • Extensive experience working in cross-functional teams Competencies: • Decision Making • Leadership (Scientific, Technical and Departmental) • Problem Solving • Written and Oral Communication • Innovation • Initiative • Delivery Focus • Conflict management • KOL engagement2012-02-01 02:26:20United KingdomAmgenNone13453BRNoneCambridge, GBR26231372http://www.amgen.jobs/xml/26231372/jobUSAWest GreenwichAuto req 13625BR Job Posting Title Sr Project Mgr Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - Rhode Island Location (City) West Greenwich Amgen Job Description The Project Management Organization (PMO) is responsible for Program and Project Management, Project Portfolio Management and Project Support functions at the Amgen Rhode Island (ARI) site. The Senior Project Manager position presents an opportunity for a qualified candidate to further enhance their leadership skills, apply proficiency in project management to effectively manage large, highly complex programs, demonstrate versatility, and cultivate financial acumen and overall understanding of Amgen’s business. This highly visible position interacts with all levels of the organization. The candidate must have a proven track record in project management, strong leadership and communication skills, and the ability to approach issues from a strategic perspective. This includes the ability to translate strategy into challenging, actionable objectives to effectively drive cross functional teams, advocate client positions throughout the project life cycle, and make value-based decisions. Primary responsibilities include leadership of multi-faceted, cross-functional and global projects as well as mentoring less experienced project managers at the Amgen Rhode Island site. The PMO leads a wide breadth of projects, including: - New Product Introductions and Tech Transfers - Large Capital Projects - Process related improvements (i.e., next generation product introductions) - Global System deployments (i.e., SAP/ERP/MES) - Operational Excellence initiatives (e.g., Business process improvements, supplier relationship initiatives, etc.) Under minimal guidance, the candidate must manage all aspects of their project(s): planning, cost, schedule, risk, communications, resources, team dynamics and performance, implementation, monitoring, completion and follow-up. Basic Qualifications ? Doctorate degree & 2 years of directly related experience OR ? Master’s degree & 6 years of directly related experience OR ? Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Project management Professional (PMP) certification • Strong knowledge of biotech manufacturing processes and/or Amgen information systems • Strong leadership and motivational skills • Strong project management skills • Experience leading large cross-functional teams • Demonstrated ability to forge and maintain strong relationships within multiple functional areas • Ability to tactfully and effectively negotiate and influence • Ability to communicate and present ideas to all levels of staff and management • Ability to multi-task and function in a dynamic environment • Experience leading teams or organizations (e.g. management of direct staff) • High proficiency in project management methodology and tools (e.g., MS Project, @RISK, etc.) • Understanding of operational excellence, including continuous improvement methodologies (e.g., Lean, Six Sigma, Catalyst, etc.)2012-01-30 23:42:37United StatesAmgenRhode Island13625BRRIWest Greenwich, RI26200954http://www.amgen.jobs/xml/26200954/jobUSAThousand OaksAuto req 13695BR Job Posting Title Health Economics Senior Manager - Bone Health Career Category Health Economics Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Develops Health Economics strategies and projects that leverage the value proposition created by the Global and Regional Health Economics, Medical and Business teams. Develops, implements and oversees the health economics and outcomes projects to support the Amgen product across its lifecycle. Responsibilities: 1. Develops Global and Regional value propositions 2. Develops pharmacoeconomic models (cost utility, cost effectiveness, cost offset, budget impact, etc), both independently and in collaboration with vendors and key opinion leaders. 3. Develops annual strategic plans and research projects that support the value proposition including outcomes research, patient reported outcomes, and health economics modeling 4. Creates and maintains the Global Value Dossier 5. Performs health economics projects from inception to completion and publication including creation of Study Concept Documents, Protocols, Analysis Plans and Final Study Reports 6. Review and critique medical and evidence-based outcomes literature 7. Manages researchers and health economics vendors external to the company 8. Works with teams to create and implement payer, value and publication plans 9. Works with Clinical Development study teams 10. Interacts with and presents to multiple departments within Amgen: - Health Economists in Europe, Canada and Australia; - Development including Clinical Science, Epidemiology and Biostatistics; - Global Commercial including the Global Commercial Leader and Global Pricing; - and US Business Units including Product Director, Access Managers, Corporate Accounts and Global Government Affairs. 11. Builds relationships with Key Researchers and Opinion Leaders 12. Manages project budgets Basic Qualifications -Doctorate degree & 2 two years of directly related experience OR -Master’s degree & 6 six years of directly related experience OR -Bachelor’s degree & 8 years of directly related experience Preferred Qualifications -Masters, PharmD or PhD in Health Economics, Outcomes Research, Health Services Research. -4 or more years of experience in global outcomes research including dossier submissions for reimbursement. -3 or more years of experience developing pharmacoeconomic models. -3 or more years of experience in PRO/HRQOL research including questionnaire design, evaluation, and/or analysis. -Experience working with consumers of outcomes information. -Sophisticated modeling skills.2012-01-27 20:49:31United StatesAmgenCalifornia13695BRCAThousand Oaks, CA26163818http://www.amgen.jobs/xml/26163818/jobUSALongmontAuto req 13452BR Job Posting Title Dir EH&S Career Category Quality Employee Subgroup Salaried FT Country (State/Region) United States - Colorado Location (City) Longmont Amgen Job Description Job Summary: An experienced Environment, Health & Safety Director (EHS) to provides vision and strategy for site and/or global EHS initiatives. Responsible for keeping site senior management informed on the status of environment, safety and health matters affecting the site. Assists Site Quality Executive Director in formulating and executing company practices as they related to environment, safety and health performance. Delivers results through influence and communicating effectively with clients and practical integration of EHS with business practices. Independently take actions to drive improvement in EHS performance and practices. Manage complex problems and coordinate the implementation of innovative solutions. Functions (Duties/Accountabilities): EHS Management: Develop a management system which ensures that EHS is a key component of all site activities. Applies practical environment, safety, and health operating standards to ensure continuous improvement in EHS performance at the site. Influence line management to ensure that EHS is managed by line management as a core skill. Implement CAPA program to ensure actions are taken in a timely manner for effective close out of all findings from incidents, risk assessments, inspections and audits. Incident management: Incident investigation and root cause analysis, reducing potentially serious incidents, injuries, environmental incidents, case management and injury prevention programs Risk Management: Risk assessment for various aspects of EHS and capable of implementing a program at all levels of the facility. Knowledge and experience of process hazard evaluation techniques such as What If, HAZOP, FMEA. Safety culture programs: Develop and implement Amgen safety culture program to integrate EHS as part of the day to day operations. Ensure early reporting by staff of unsafe conditions and behavior and near misses. Project design review: Implement process for carrying out EHS review of projects, a management of change process, and handover and commissioning processes. Contractor safety management: Ensure contractors comply with Amgen EHS requirements. EHS Program Compliance: Provide technical guidance for the implementation of Amgen’s Environment, Industrial Hygiene, Occupational Health and Safety programs to ensure compliance. Engineering safety: Permit to work, Lock out tag out, confined space entry, cranes and hoist Personal Protective Equipment: - Managing hazardous substances including flammable and combustible materials, biologics, regulated carcinogens and controlled substances - Employee exposure determinations - Ergonomic design and assessment - Fire and life safety - Waste management - Air and waste water permitting and compliance Process safety management: Oversee management of chemical inventory and waste management programs (chemical, biohazard, radiation, universal, etc.). Regulations: Implement systems to ensure compliance with applicable EHS regulations. Evaluate existing and new regulations’ impact upon Amgen operations. Develops new programs and implement changes as necessary. Training: Implement EHS training strategy for Amgen staff & contractors and develop new training programs as required. Environmental Sustainability: Implement programs to ensure accurate data is collected for the sites environmental impact and to reduce the ongoing environmental impact of the site’s operations. Internal Auditing: Communicate audit results to site senior management. Review findings for trends and/or improvement opportunities that affect the site. Supervision: Managing staff and/or technical personnel in multi-tiered organization. Basic Qualifications Doctorate degree and 4 years of directly related experience OR Master’s degree and 8 years of directly related years OR Bachelor’s degree and 10 years of directly related experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications MS Degree environmental, safety, industrial hygiene, technical, scientific or engineering 12 or more years of experience developing and implementing EHS programs in a biotechnology/pharmaceutical company Experience in implementing an EHS management system (OHSAS 18000, ISO 14000). 7 years of supervisory experience Knowledge with European regulations as they pertain to pharma/ biotech operations Applied knowledge and understanding of EHS principles and practices, regulatory standards, and requirements in context of business activities. Postgraduate professional qualification preferred (e.g. Certified safety practitioner (CSP)) Leadership, team building, strong communication skills, action oriented, self starting, program development and project management. Proficient in Microsoft Office and other computer software systems. Good technical & business writing skills and team skills.2012-01-26 22:26:16United StatesAmgenColorado13452BRCOLongmont, CO26140230http://www.amgen.jobs/xml/26140230/jobUSAThousand OaksAuto req 13582BR Job Posting Title Regulatory Affairs Sr Mgr (GRAAS Biosimilars-CMC) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans. - Coordination of global regulatory CMC activities relevant to the successful execution and implementation of biosimilar CMC regulatory strategies and plans - Development of CMC and analytical dossiers required for registration of biosimilar products - Management of long term CMC planning and regulatory CMC submissions for licensed products Key Activities: Regulatory Strategy and Filing - Provide expertise in the development, communication, and implementation of global CMC regulatory strategies in support of Biosimilars Operating Unit’s goals and product portfolio execution - Ensure regulatory documents (including analytical similarity packages and quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents as required) are developed with high quality and delivered in a timely manner - Lead cross-functional teams in development and submission of Quality documents, including responses to questions from regulatory authorities - Maintain product licenses per regulatory requirements and updated according to long-term plans - Support development and execution of clinical and non-clinical plans - Develop and deliver analytical similarity packages that meet biosimilar regulatory requirements, as directed by the RA CMC Lead - Deliver CMC information for submissions (including Module 3, analytical similarity assessments) - Prepare for and participate in CMC-related agency interactions - Represent RA CMC on the TOST and TOET - Provide CMC functional support for Amgen Biosimilars Operating Unit - Collaborate with other GRAAS functions on biosimilar issues, (eg, CMC, Regulatory Operations, Devices) - Comply with critical GRAAS CMC processes Regulatory Intelligence - Monitor, assess and implement regional CMC regulatory requirements - Review and assess CMC impact of health authority decisions for competitive products - Generate and communicate CMC intelligence to the Amgen Biosimilars Operating Unit Collaboration - Participate in vendor oversight and management for regulatory CMC operations, as required - Provide regulatory risk assessment to the GRAAS Biosimilars function and to CMC filing teams - Identify process needs to meet internal challenges - Escalate CMC issues, progress, and metrics to the GRAAS Biosimilars function - Represent Biosimilars Regulatory Affairs CMC on committees, as necessary Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - CMC-specific regulatory knowledge and experience - Ability to understand and communicate scientific information - Ability to anticipate and prevent potential issues - Ability to communicate regulatory requirements to ensure expectations are understood - Industry experience in manufacture, testing (QC/QA), or distribution - Global regulatory CMC knowledge and experience - Regulatory submissions experience - Working with policies, procedures and SOPs - Experience in analytical similarity or comparability assessments and development of associated packages2012-01-25 21:04:52United StatesAmgenCalifornia13582BRCAThousand Oaks, CA26111472http://www.amgen.jobs/xml/26111472/jobUSAThousand OaksAuto req 13567BR Job Posting Title Regulatory Affairs Sr Mgr (GRAAS Biosimilars) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Group Purpose: To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans. Job Summary: - Coordination of global regulatory activities relevant to the successful execution and implementation of biosimilar regulatory affairs strategies and plans - Development of regulatory dossiers and briefing documents required for clinical trials and registration of biosimilar products - Ensure compliance with regulatory requirements to support ongoing clinical trials - Ensure compliance with regulatory requirements for licensed products Key Activities: Regulatory Strategy and Execution - Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, MAs, and Responses to Questions for products within the biosimilars portfolio in compliance with approved filing plans, timelines, and regulatory requirements - Provide regulatory direction on regional regulatory requirements to optimize product development timelines - Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning - Support development and execution of clinical/ non-clinical strategies - Provide review, input, and regulatory advice into study concept documents, study protocols, informed consent forms, statistical analysis plans, clinical study reports and related regulatory documents used to support product development and registration - Participate and collaborate with labelling teams on the development of global product labels and core data sheets to align commercial objectives with expected regulatory guidance and precedent - Collaborate with Amgen affiliates as required to ensure effective implementation of global regulatory strategies and plans - With minimal supervision, participate in development of risk management and contingency planning - Ensure and lead regulatory compliance for biosimilar products (eg, PMCs and other agency commitments) Regulatory Intelligence - Monitor, assess and implement regional regulatory requirements, guidelines, and policies relating to biosimilar products - Review and assess impact of regulatory decisions for competitive products - Generate and communicate biosimilar intelligence Collaboration - Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products - Contribute to appropriate, and participate in, vendor oversight and management for regulatory and safety operations - Identify process needs to meet internal challenges - Escalate regulatory issues, progress, and metrics to the GRAAS Biosimilars function - Represent Biosimilars Regulatory Affairs on committees, as necessary Knowledge and Skills - Comprehensive understanding of Regulatory and Safety functional activities and how they affect projects and processes - Regulatory experience with product filings - Ability to understand and communicate scientific and clinical information - Ability to anticipate and prevent potential issues - Ability to communicate regulatory strategies and requirements to ensure expectations are understood - Cultural awareness and sensitivity to achieve results across different regions Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - RAC - Regulatory knowledge of global regulations - Regulatory submissions experience - Working with policies, procedures and SOPs - Interacting with regulatory agency representatives - Understanding of drug development2012-01-25 21:04:29United StatesAmgenCalifornia13567BRCAThousand Oaks, CA26111457http://www.amgen.jobs/xml/26111457/jobTURIstanbulAuto req 12334BR Job Posting Title Sr Biopharmaceutical Rep Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) Turkey Location (City) Istanbul Amgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications2012-01-17 22:01:03TurkeyAmgenNone12334BRNoneIstanbul, TUR25943896http://www.amgen.jobs/xml/25943896/jobUSAThousand OaksAuto req 13402BR Job Posting Title Legal Coordinator, Employment Law Career Category Law/Legal Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Legal Coordinators are primarily responsible for complex administrative support activities, which may include preparing and/or processing technical material/reports/forms using a wide variety of text editing software and managing features (formatting, editing, deleting, updating, etc.), creating, testing and implementing Microsoft Word macros and templates, and occasionally assisting supervisor in coordination of management issues, (i.e., focal reviews, goals and department/staff goals and objectives). Legal Coordinators will also manage multiple and/or complex calendars, coordinate domestic/international travel arrangements, and expense reporting. Additional responsibilities include independently coordinating calendar meetings, complex onsite/offsite meetings, leading administrative projects, providing management with status/activity reports, and selecting appropriate format for presentations. Assisting staff members with compiling documents for submissions including the formatting and distribution of submissions. Legal Coordinators will also be responsible for taking, transcribing, and distributing meeting minutes, project tracking (i.e., budget, database, timelines), as well as demonstrating the ability to interact with outside vendors and various levels of management. Basic Qualifications • Associate’s degree & 2 years of directly related experience OR • High school diploma / GED & 4 years of directly related Preferred Qualifications - Large law firm or in-house law department experience highly desirable. - Outlook, Word, Excel and PowerPoint experience are preferred - Associates degree is preferred2012-01-11 20:37:04United StatesAmgenCalifornia13402BRCAThousand Oaks, CA25834400http://www.amgen.jobs/xml/25834400/jobMEXMexico CityAuto req 10219BR Job Posting Title Product Mgr Employee Subgroup Salaried FT Country (State/Region) Mexico Location (City) Mexico City Amgen Job Description 40000163, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40000163, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40000163, To Be Added When Table Structure is Built, - Preferred Qualifications2012-01-07 19:06:21MexicoAmgenNone10219BRNoneMexico City, MEX25756784http://www.amgen.jobs/xml/25756784/jobUSAThousand OaksAuto req 13073BR Job Posting Title Global Safety Medical Director - Oncology Career Category Safety Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This is an opportunity for a Medical Director to serve in a Global Safety Officer GSO role within the Oncology Therapeutic area in Amgen Global Safety. The role is located at Amgen's headquarters in Thousand Oaks, California. The Global Safety Medical Director (also known as the Global Safety Officer (GSO)) leads by establishing the direction and priorities of the Global Safety Team (GST) and is accountable for all product safety related GST decisions for assigned products and is the key interface between the GST, Therapeutic Area Head (TAH), Amgen Global Safety Senior Management, and other Amgen functional areas. The GSO, supported by the Global Safety Project Manager, is responsible for the timely communication of safety recommendations and/or actions from the GST to internal and external stakeholders. This role leads single projects which can be of moderate or high complexity / scope or multiple projects of lower complexity closely collaborating with the Therapeutic Area Head. Key Activities: Accountable for identification, assessment, and communication of potential safety signals as leader of GST pharmacovigilance activities GST representative on the PST (commercialization) accountable for GST PST deliverables Lead response to regulatory safety queries Lead development of strategy and creation of product risk management plans including maintenance and updates Accountable for Global Safety Strategic Plan (GSSP) Safety representative for assigned products at meetings with Regulatory authorities, data safety monitoring committees, advisory boards Participate in planning, review and sign off of clinical trial safety documents for content including: o Clinical Summary of Safety (CSS) o 120 Day safety update o Protocol safety sections o CSRs o ICFs o Study safety monitoring plans o Investigator Brochures Basic Qualifications MD or DO degree from an accredited medical school 2+ years of safety experience Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications Drug safety, biotech/pharmaceutical or regulatory agency experience Board Certification by an accredited medical or surgical board e.g. ABIM, ABMS, EUMS2011-12-23 19:32:33United StatesAmgenCalifornia13073BRCAThousand Oaks, CA25538814http://www.amgen.jobs/xml/25538814/jobGBRUxbridgeAuto req 13137BR Job Posting Title Regulatory Affairs Mgr Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Uxbridge Amgen Job Description 40001053, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40001053, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40001053, To Be Added When Table Structure is Built, - Preferred Qualifications2011-12-21 22:00:18United KingdomAmgenNone13137BRNoneUxbridge, GBR25502621http://www.amgen.jobs/xml/25502621/jobCHEZug - HQAuto req 13040BR Job Posting Title Regional Access Lead Career Category Government Affairs Employee Subgroup Salaried FT Country (State/Region) Switzerland Location (City) Zug - HQ Amgen Job Description The person must oversee and coordinate development and implementation of strategies in Emerging Europe (Russia, Turkey, MEA) to secure/maintain access at optimal prices for all Amgen in-market and launching products. This individual must work with collaborators in the IP3 and IHE organization as well as the Emerging Markets Europe Team, distributors, partners, and the individual Affiliate Value & Access Leads to translate” product strategy into specific operational tactics that are most effective at a country-specific level. Internal Accountabilities • Partner with Executive Director, ICO EM Europe, to understand strategic business imperatives and access objectives • Foster collaboration with cross-functional partners as well as PALs and Affiliate V&A Leads in support of access in EM Europe • Ensure close partnership with IHE Lead in EM Europe to align strategy and evidence generation to support value proposition • Ensure close partnership with International Governmental Affairs Lead in EM Europe to develop optimal approach with governmental payers • Ensure close partnership with International Pricing and Contracting Lead in EM Europe to align pricing and contracting strategies with overall access plans Accountabilities for External-Facing Activities • Anticipate changing payer landscape across the EM-Europe region by building and maintaining deep understanding and knowledge of payers, including emerging trends that can impact access for Amgen products • Support local strategies and execute regional strategies within EM Europe to collaborate proactively with payers and HTAs, particularly in understanding payer perceptions, engaging in discussions of our pipeline evidence generation plans, and fostering collaborative relationships. • Coordinate with ICO Pricing and Contracting EM Lead, and EM Team, as well as Affiliate V&A Leads to ensure robust price and contracting strategies across the portfolio in EM Europe and consider alternative pricing mechanisms as needed to secure access (Support ICO Pricing and Contracting). Ensure appropriate business case development and assessment of trade-offs when considering price reductions to secure reimbursement • Coordinate with IHE EM Europe Lead and Affiliate V&A Leads to ensure robust value evidence generation and articulation of product value that is aligned with access strategies in EM Europe (Support IHE) • Partner with HTA and Payment Policy Team and Affiliate V&A Leads to understand key policy issues and inform Amgen policy positions in order to shape the policy landscape (Support HTA and Payment Policy Team) • Drive development and implementation of access strategies within EM Europe across the portfolio • Coordinate access training and best-practice sharing across EM Europe, especially among affiliates that share similar pricing and reimbursement structures Deliverables • Emerging Europe Payer Situational Analysis: annual snapshot of reimbursement planning assumptions including identification of evolving trends • Payer Research: Primary and secondary research with payers within the Emerging Markets Europe to answer specific questions needed to refine local access strategies. Intended to supplement research done by GP3 and other regional V&A colleagues. Includes: • Emerging Markets Europe sections of ICO Product Value and Access Plans (Collaborate with PALs) and Global Payer Plans (Collaborate with GPLs) • Affiliate/Distributor/Partner Access Plans (Collaborate with and provide dotted-line supervision to Affiliate V&A Leads; review plans with assigned personnel from distributors and partners) • Achievement of access plan: price at or above target, timely reimbursement when deemed desirable for appropriate target population Basic Qualifications • Higher education (University degree) and an MBA is highly valued • At least 2-3 years of experience in a similar position • Strong understanding of European Emerging Markets payer environment and demonstrated capability/experience in coverage and reimbursement, pricing and contracting, value drivers and value communication, value evidence, health technology assessment, HTA and payment policy • Strong leadership skills with demonstrated ability to lead cross-functional teams and engage in productive debate and collaboration with senior leaders across the organization • Excellent communication skills, including interpersonal skills to foster collaboration and succeed in a highly matrixed environment • Strong oral/written presentation skills • Strong strategic planning skills—both at the product level as well as at the country (cross-portfolio) level • Ability to conduct situation analysis of external pricing and reimbursement environment and to synthesize relevant information to support development of country-specific strategic plans • Ability to identify the most compelling way in which to demonstrate and communicate product value to payers • Capability to interact with external stakeholders at multiple levels and to influence course of action through value communication, policy arguments, and negotiation Preferred Qualifications • Customer and HTA agency engagement • Direct payer experience and/or experience in product commercialization desirable • Regional or global experience strongly preferred • Strategic planning and health policy experience strongly preferred • Strong understanding of strategic pricing and contracting, including innovative approaches such as risk-sharing deals • Ability to review clinical and health economic literature, including disease state information, clinical trial design and results, and pharmacoeconomic studies in order to understand implications for value to payers2011-12-16 19:10:56SwitzerlandAmgenNone13040BRNoneZug - HQ, CHE25420880http://www.amgen.jobs/xml/25420880/jobMEXField BasedAuto req 10246BR Job Posting Title Sr Biopharmaceutical Rep Employee Subgroup Sales Incentive FT Country (State/Region) Mexico Location (City) Field Based Amgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications2011-12-10 21:07:25MexicoAmgenNone10246BRNoneField Based, MEX25288986http://www.amgen.jobs/xml/25288986/jobMEXField BasedAuto req 10253BR Job Posting Title Sr Biopharmaceutical Rep Employee Subgroup Sales Incentive FT Country (State/Region) Mexico Location (City) Field Based Amgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications2011-12-09 20:24:33MexicoAmgenNone10253BRNoneField Based, MEX25276926http://www.amgen.jobs/xml/25276926/jobMEXField BasedAuto req 10251BR Job Posting Title Sr Biopharmaceutical Rep Employee Subgroup Sales Incentive FT Country (State/Region) Mexico Location (City) Field Based Amgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications2011-12-08 21:29:22MexicoAmgenNone10251BRNoneField Based, MEX25259576http://www.amgen.jobs/xml/25259576/jobMEXMexico CityAuto req 10226BR Job Posting Title Product Mgr Employee Subgroup Salaried FT Country (State/Region) Mexico Location (City) Mexico City Amgen Job Description 40000163, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40000163, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40000163, To Be Added When Table Structure is Built, - Preferred Qualifications2011-12-06 19:04:36MexicoAmgenNone10226BRNoneMexico City, MEX25209001http://www.amgen.jobs/xml/25209001/jobUSAThousand OaksAuto req 12719BR Job Posting Title Sr Associate IS Bus Sys Analyst (SharePoint) Career Category Information Systems Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Ideal Candidate will be a highly motivated, detail oriented, and self-sufficient individual with strong technical and communication skills to assist in maintaining our SharePoint infrastructure including SharePoint 2010 and SharePoint 2007 farms. As part of the growing Web and Collaboration group, the candidate will work closely with other administrators, developers, architects and business analysts. This position will play a strong technical role in providing SharePoint expertise to the Web Services COE. Responsibilities may include system ownership, custom development, technical troubleshooting, metrics development, basic architectural analysis, and vendor management. Candidates should possess a strong ability to learn new technologies, and be able to work in a high pressure, fast paced environment. Basic Qualifications • Master’s degree OR • Bachelor’s degree & 2 years of directly related experience OR • Associate’s degree & 6 years of directly related experience OR • High school diploma / GED & 8 years of directly related experience Preferred Qualifications Excellent documentation and writing skills are crucial. The ability to develop, document and communicate processes and follow accepted Amgen IS policies and standards is mandatory. Candidates must be able to work independently and provide recommendations on strategies for meeting client needs within the scope of the COE’s service offerings. He or she should have the ability to see the big picture and zoom-into specific areas to provide a creative approach to problem solving, innovation and issue resolution. The Candidate should have good interpersonal skills and the ability to communicate and collaborate proactively with others. Experience with software development processes including source code control, functional and performance testing, and technical documentation, as well as, experience managing an enterprise-class system is highly desired. • SharePoint 2007 or SharePoint 2010 • Formalized requirements gathering • Active Directory or similar authentication protocols • Working knowledge of SQL Server database architecture • Microsoft Online Services (BPOS/Office365) • Microsoft Server Administration • Software Development Methodologies • Unit and Integration Testing • Object-Oriented Programming Languages (i.e. C#) • Web Technologies2011-12-04 19:40:37United StatesAmgenCalifornia12719BRCAThousand Oaks, CA25175614http://www.amgen.jobs/xml/25175614/jobUSAThousand OaksAuto req 12909BR Job Posting Title Reimbursement Director - Emerging Markets, Global Pricing & Payor Planning Career Category Government Affairs Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Participate as a member of Amgen's Global Pricing and Payer Planning Team with specific focus on Asia and/or Latin America. The global team is responsible for strategic planning to support value and access for all Amgen molecules in development, beginning in Phase I-II and extending throughout commercialization across the Amgen portfolio. This includes lifecycle planning and access support for our inline molecules. Additionally, the team is responsible for global strategic pricing, including recommendations for global price bands and launch sequence. As a global function, this team is responsible for global pricing & access strategy across all regions, including those in Emerging Markets. Each Director in Emerging Markets will cover a specific region and will represent payer needs of that region and be a resource to the Global Payer Leaders. He/she will assess the pricing and access environments for various markets and the associated implications for the Amgen portfolio. Additional responsibilities will include development of processes/procedures to incorporate value & access activities for Asia and/or Latin America into the commercialization process and deliverables. The Global Payer Leaders represent payer needs on the multi-disciplinary Product Strategy Team for one or more molecules. They also lead Global Payer Team(s) that support the payer planning process, including the situation analysis and the creation of global payer plans. Each global payer plan integrates coverage and reimbursement, pricing, value evidence, and policy into the development of a strategic plan that supports the overarching commercial objectives and links to the clinical attributes of the molecule. The plan elucidates and communicates the strategies and tactics to secure and maintain access throughout the lifecycle of a specific molecule. Each member of the team must work collaboratively across functions to ensure a comprehensive view of his/her assigned product/region and create and maintain strong collaborative working relationships with key stakeholders. These stakeholders include colleagues in marketing, development, health economics, regulatory, operations, and government affairs. The individual must also oversee and conduct relevant payer/pricing research and integrate cross-functional information to develop and communicate strategy. In addition to product-specific or regional responsibilities, each team member also participates in one or more cross-portfolio projects each year. These projects either serve to advance the team’s knowledge of and readiness for the global payer environment, support specific market or product assessments, or attempt to influence payer policy development. Examples include: Payer assessments to support potential mergers/acquisitions, exploration of new payer trends (e.g., bundling), or development of a policy white paper to shape external price and reimbursement policies in the global arena. Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience Preferred Qualifications • Strong understanding of pricing, payer and access environments in emerging markets in Asia and Latin America, including local pricing and access strategies; affordability issues and healthcare reform and future trends • Previous assignment with responsibility in Asia and/or Latin America • Understanding of payer environment, both within the US and globally, including coverage and reimbursement, pricing, value drivers, formulary management, health technologies assessment, health policy • Ability to conduct situation analysis of external pricing and reimbursement environment and synthesize relevant information to develop strategic plans • Ability to conduct qualitative and quantitative pricing studies and to formulate price policy recommendations • Ability to formulate health policy strategy and implement these strategies to shape external pricing and reimbursement environment • Ability to review clinical and health economic literature, including disease state information, clinical trial design and results, and pharmacoeconomic studies, in order to understand implications for value to payers • Excellent communication skills, including interpersonal skills to foster collaboration and succeed in a highly matrix environment; strong oral/written presentation skills • Demonstrated success as a team leader with strong team management skills • Direct payer experience and/or experience in product commercialization desirable • Strategic planning and health policy experience strongly preferred • Pharmaceutical pricing experience strongly preferred • Oncology pricing, reimbursement, and access experience desirable2011-12-02 22:31:03United StatesAmgenCalifornia12909BRCAThousand Oaks, CA25162788http://www.amgen.jobs/xml/25162788/jobUSAWest GreenwichAuto req 12850BR Job Posting Title Sr Specialist Manufacturing Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) United States - Rhode Island Location (City) West Greenwich Amgen Job Description Manufacturing Senior Specialist Description: Independently lead the execution of manufacturing/quality systems such as non-conformance investigations, process validation, major change control initiatives, development of staff training, new product introductions, and corrective and preventative actions. Apply advanced process, operational, scientific expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as the primary production process owner for operations and assist with system ownership responsibilities. Independently make complex decisions regarding operations, process or business practices. Lead cross-functional teams through implementation of major projects, corrective and preventative actions. Applied Process Expertise 1. Serve as subject matter expert in manufacturing. 2. Provide real time support for production manufacturing failures and recovery. Non-Conformance and CAPA 3. May be responsible for managing the site NC and CAPA program for manufacturing. Process and Equipment Validation 4. May serve as a liaison and coordinator for manufacturing validation activities. 5. Lead process validation projects. Compliance 6. Support regulatory inspections by directly interfacing with inspectors to review batch records, process validation, non-conformances, etc. 7. Present process overviews to inspectors and accompany inspectors on tours of process areas. 8. May serve as a quality system owner. Change Control 9. Serve as a manufacturing change owner for major change controls Projects and Initiatives 10. Serve as a project manager of cross-functional projects. 11. May represent manufacturing on site and global teams and initiatives. ** Other functions that may be assigned Basic Qualifications Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies Previous technical experience managing people, and leading teams on major projects, initiatives or programs Aseptic processing practical experience Demonstrated proficiency of written and verbal communication skills (including technical writing and technical presentations) Ability to communicate and collaborate effectively with technical and senior management staff. Track record of increasingly complex manufacturing or manufacturing support experience in biotechnology, pharmaceuticals or a related industry Experience that has provided the candidate with a detailed understanding of the regulatory and compliance environment, the GMP processes and the business processes associated with typical biotechnology / pharmaceutical manufacturing operations Experience leading cross-functional teams in investigations into manufacturing deviations and determination of potential manufacturing impact and root cause, and application of corrective actions. Able to solve complex problems and make scientific risk based recommendations under ambiguous circumstances Experience representing Amgen while interacting with representatives of regulatory agencies. Experience in managing multiple, competing priorities in a fast paced environment.2011-12-02 22:30:56United StatesAmgenRhode Island12850BRRIWest Greenwich, RI25162784http://www.amgen.jobs/xml/25162784/jobUSAThousand OaksAuto req 9815BR Job Posting Title Health Economics Senior Manager - Oncology Career Category Health Economics Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Assists in the development of Health Economics strategies and leads projects that leverage the value proposition created by the Global and Regional Health Economics, Medical and Business teams. Develops, implements and oversees health economics and outcomes projects to support the Amgen product across its lifecycle. Responsibilities: 1. Assists in the development of Global and Regional value propositions 2. Develops pharmacoeconomic models (cost utility, cost effectiveness, cost offset, budget impact, etc), both independently and in collaboration with vendors and key opinion leaders. 3. Assists in the development of annual strategic plans and research projects that support the value proposition including outcomes research, patient reported outcomes, and health economics modeling 4. Assists in the creation and maintenance of the Global Value Dossier 5. Performs health economics projects from inception to completion and publication including creation of Study Concept Documents, Protocols, Analysis Plans and Final Study Reports 6. Review and critique medical and evidence-based outcomes literature 7. Manages health economics vendors external to the company 8. Works with teams to create and implement payer, value and publication plans 9. Works with Clinical Development study teams 10. Interacts with and presents to multiple departments within Amgen: - Health Economists in Europe, Canada and Australia; - Development including Clinical Science and Biostatistics; - Global Commercial including the Global Commercial Leader and Global Pricing; - and US Business Units including Product Director, Access Managers, Corporate Accounts and Global Government Affairs. 11. Builds relationships with Key Researchers and Opinion Leaders 12. Manages project budgets Basic Qualifications -Doctorate degree & 2 two years of directly related experience OR -Master’s degree & 6 six years of directly related experience OR -Bachelor’s degree & 8 years of directly related experience Preferred Qualifications -Masters, PharmD or PhD in Health Economics, Outcomes Research, Health Services Research. -3 or more years of experience in global outcomes research including dossier submissions for reimbursement. -3 or more years of experience developing pharmacoeconomic models. -3 or more years of experience in PRO/HRQOL research including questionnaire design, evaluation, and/or analysis. -Experience working with consumers of outcomes information. -Sophisticated modeling skills.2011-12-01 22:28:45United StatesAmgenCalifornia9815BRCAThousand Oaks, CA25141667http://www.amgen.jobs/xml/25141667/jobUSAThousand OaksAuto req 12946BR Job Posting Title Business COE Mgr Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role will consist of supporting ongoing business processes and systems for master data and security in the ERP system. The manager will support an ongoing system of services and controls over master data to assure accuracy and integrity, which in turn provides a reliable basis for sustainable business processes and decision making. The governance of master data is required to ensure consistency (i.e. global compliance with defined uses) and usage across processes and systems with a scope of Material, Customer, Vendor, Employee, and Asset (WBS Element). The manager will also support the goals of Amgen’s business units by assuring the appropriate access to ERP as well as specific identified systems (e.g., GCPS, eFinity), in compliance with various rules and regulations with respect to Amgen’s ERP framework, i.e. SOX, GMP, Unblinding, Privacy. Specifically this role will: • Develop and support SAP master data and security governance and control systems • Drive value-add improvement of security and master data management especially in the ERP system • Manage and develop data conversions, mass updates, and data-quality reports/metrics • Monitor SAP data quality • Protect SAP master data design integrity • Assess proposed changes for SAP master data impact • Monitor ERP access via SOX 40.1.3 SAP Security Monitoring • Support SOX Process Owners’ and business leads with their quarterly SOX certification processes and related audit observations • Authorize changes to security roles, limiting the risk of segregation of duties occurrences, and maintaining the confidentiality of restricted information • Monitor all security role changes promoted to production • Demonstrate thorough understanding of business processes and priorities as related to the ERP system • Lead cross-functional teams • Participate in key projects Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Understanding of SAP master data and/or security • SAP experience using Virsa or GRC or equivalent software • Prefer 3 years of experience in a business function using an ERP system • Experience with access controls/design in IS systems • Experience in internal controls design and operational effectiveness • Computer related system qualification in a regulated industry • Experience defining data-conversion requirements and/or review of data for an ERP implementation • General understanding of Biotech/Pharmaceutical company operations • Understanding of ETL (extract, transform, load) • Understanding of systems outside of ERP, such as Ariba, EDI, Maximo, WERUM is a plus. • CranSoft experience a plus • Minimum 6 years of experience working with an ERP system • Firm understanding of relational databases • Experienced in SQL Server queries or equivalent basic programming • Information Systems Audit and/or SOX certification experience • Skilled at planning and project management • Competencies include business analysis and process mapping • Ability to work independently under minimal direction • Effective team member • Excellent written and verbal communication skills • Detail oriented; excellent organizational and analytical skills • Positive attitude and a strong work ethic2011-11-29 18:32:37United StatesAmgenCalifornia12946BRCAThousand Oaks, CA25085030http://www.amgen.jobs/xml/25085030/jobUSAThousand OaksAuto req 12729BR Job Posting Title Biomedical Data Stewardship Sr Manager Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description • Drive and facilitate the expansion of data presentation standards within GBDS taking primary responsibility for standardizing the presentation of clinical trial results in Tables, Figures and Listings. The role is positioned within the Biomedical Data Stewardship (BMDS) organization and the successful candidate would work alongside other BMDS staff in the development of end-to-end data standards and ensure that TFL requirements are considered in the development of collection standards. • Lead the Global Standardized Data Presentation Governance Committee • Lead the continuous improvement of data presentation processes and supporting technology Responsibilities: • Ensuring best data presentation practice through leadership of cross-functional Global Standardized Data Presentation Governance Committee • Maintaining compliance and compatibility with CDISC standards particularly ADaM. • Contributing to the development and strategy of the GBDS Data Stewardship organization Key Activities: • Collaborate cross-functionally and within GBDS Data Stewardship to drive forward compliance with standards, processes and training • Track key metrics and reporting to GBDS and R&D Senior Management • Lead, motivate and develop the Global TFL Committee • Develop and maintain strong working relationships with key stakeholders Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - Bachelors degree in statistics/ biostatistics, programming, life science, computer science - 8 years work experience in data management, biostatistics or programming in the Pharmaceutical or Biotech arena - 3+ years experience in a global organization - Demonstrated ability to influence decision making - Development of policies and SOPs - Experience collaborating on global cross-functional teams - Knowledge of project management, documentation writing, training, and compliance - Interest in process improvement methodologies - Use of software and data applications within drug development - Appreciation of computer system architecture and hardware2011-11-28 21:33:28United StatesAmgenCalifornia12729BRCAThousand Oaks, CA25067075http://www.amgen.jobs/xml/25067075/jobUSASouth San FranciscoAuto req 12764BR Job Posting Title Clinical Data Management Systems Manager - Electronic Data Capture (EDC) Operations Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Thousand Oaks Amgen Job Description This role may be based at Amgen's corporate headquarters in Thousand Oaks, California, or at Amgen's South San Francisco site. The CDM Systems Mgr – EDC Operations is the technical Subject Matter Expert and point-of-contact to ensure electronic clinical data management operations of Amgen’s global Electronic Data Capture Operations service. The manager will have operational responsibility for delivery of electronic data collection systems such as Medidata Rave and Oracle InForm. These responsibilities include the delivery of EDC system capabilities, design and implementation of key system integrations, and the development of system-related EDC best practices. The position is expected to partner effectively with other CDM Systems staff to seamlessly ensure high quality deliverables such as EDC platform upgrades, EDC architecture design, integrations with internal and external clinical systems, custom report programming, and other clinical data management activities related to the use electronic data capture technology. Through active service management of service providers the manager is responsible for representing Amgen in supporting the Operational Management Team and Functional Management Team governance bodies in partnership with Amgen Global Supplier Services, ensuring quality service delivery and supplier performance. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • 3+ or more years of experience in a technical role within clinical data management, clinical development, or IS/IT • Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements • Experience successfully implementing and operating clinical data management collections systems specifically EDC platforms such as Medidata Rave and/or Oracle InForm • Medidata Rave, Oracle InForm hands-on operational and system knowledge desirable • Work experience integrating other clinical technologies including but not limited to IVRS, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred • Experience and ability creating and effectively presenting concepts and materials to senior and executive levels • Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary • Knowledge of ITIL v3 and basic Industry IS best practices • Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills • Excellent time management and organization skills required • Must have sound problem resolution, judgment, and decision-making abilities • Must be able to work well in a global team-based matrix environment with minimal supervision • Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable • Leadership Skills : The manager, EDC Operations will be a highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. The manager will have extensive clinical trial technical experience and leadership expertise. He or she will have substantial technical background to deliver the EDC operations associated with the Amgen portfolio. With strong negotiation skills, he or she will be able to address conflict head-on and facilitate rapid resolution to issues. The ideal candidate has a proven track record and experience in either working in and/or leading a technical team. The candidate must be able to represent Amgen’s business requirements and needs by effective partnering and working with outsourced service delivery partners such as an FSP, ensure operational experience with clinical database management systems (preferably Medidata Rave and Oracle InForm) and have strong communication skills to maintain a high level of transparency between CDM systems centers of excellence, clinical study team members, CDM business units, and other stakeholders.2011-11-28 21:31:18United StatesAmgenCalifornia12764BRCASouth San Francisco, CA25067023http://www.amgen.jobs/xml/25067023/jobUSAThousand OaksAuto req 12650BR Job Posting Title Regulatory Affairs Sr Mgr (device) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The RA CMC Group is responsible for generation of the global regulatory strategy and providing feedback to the team for plans and execution of the strategy. Facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Job Summary: Develop and implement regulatory strategies to support both new and existing combination products and innovative delivery devices. Key Activities: • Provide strategic expertise regarding regulatory requirements for drug delivery device related projects • Interface with Regulatory Authorities as appropriate • Work in conjunction with Global RA product leads and Regional RA representatives • Serve as Regulatory Affairs representative on Cross Functional Teams regarding drug delivery devices • Support Regulatory Filings and provide team guidance regarding: o US 510(k) filings o CE Mark requirements o Device quality management system requirements o ISO requirements o Clinical requirements for drug delivery devices o Device registration maintenance including Registration renewals o Complaints and Recalls • Review and approve selected regulatory documents • Represent Regulatory Affairs to outside departments, product teams and regulatory agencies • Represent Amgen at external events (PhRMA, PDA, ISPE, BIO, etc.), as appropriate • Develop and maintain regulatory awareness through meetings, conferences and regulatory contacts • Serve as the primary resource within the RA-CMC team to support drug/device combination products or other drug delivery device projects Basic Qualifications • Doctorate degree and 2+ years of directly related experience OR • Master’s degree and 6+ years of directly related experience OR • Bachelor’s degree and 8+ years of directly related experience OR • Associate’s degree and 10+ years of directly related experience OR • High school diploma / GED and 12+ years of directly related experience Preferred Qualifications - Degree in Life Sciences, Engineering or related field - 7+ years of related experience in the pharmaceutical/biotechnology or medical device industry - 5+ years experience in Regulatory Affairs - Regulatory experience with Drug/Device combination products or drug delivery device product filings a requirement - Ability to work within a matrix team environment - Able to operate in a fast paced, dynamic environment - Able to manage and execute activities to meet agreed upon timelines - Strong oral and written communication skills - Strong negotiating and leadership skills - International experience – preferred2011-11-03 23:36:13United StatesAmgenCalifornia12650BRCAThousand Oaks, CA24581799http://www.amgen.jobs/xml/24581799/jobUSAThousand OaksAuto req 12623BR Job Posting Title Sr Engineer - Facilities/Utilities Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description • As a member of the Clinical Bulk Facilities & Engineering organization, this position serves as the plant engineer and system owner for facility/utility systems and equipment in a bulk biopharmaceutical manufacturing facility. Responsibilities include providing operational support, troubleshooting, and optimization for assigned equipment; directing and coordinating equipment maintenance to improve reliability; and applying advanced engineering principles to the design and implementation of new equipment. • Support system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts (including identifying cycle reduction time opportunities, efficiency gains, and yield enhancement opportunities). • Lead technical root cause analysis, incident investigations, and troubleshooting on equipment (mechanical, electrical, instrumentation and control system problems). Previous formal training and/or demonstrated experience is preferred. • Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.) • Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. • Responsibilities will include support of capital projects. This role involves the application of advanced process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations. • Ensures the logical, systematic translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements. • Desired skills include demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices; ability to apply knowledge of engineering principles and practices outside of discipline expertise to a broad variety of assignments in related fields; and ability to employ advanced techniques within area of engineering expertise. • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of experience directly related to the job OR Bachelor’s degree & 5 years of experience directly related to the job OR Associate’s degree & 10 years of experience directly related to the job OR High school diploma / GED & 12 years of experience directly related to the job Preferred Qualifications • Bachelor’s degree in Chemical Engineering or Mechanical preferred • 6+ years of relevant work experience with 5+ years experience in operations/manufacturing environment • Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.) is critical. Detailed understanding of industry regulations and ability to interpret in establishing current practices. • Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization. • Ability to apply advanced engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. • Strong leadership, technical writing, and communication/presentation skills are required. • Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage. • Direct experience in equipment engineering and troubleshooting with compendial water systems (ie. Water for Injection, Purified Water, and Clean Steam), plant utility systems (eg. clean gases, chilled water, plant steam), and clean room HVAC systems. • Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformances, corrective and preventative actions, and validation practices. • Experience in design and startup engineering directly related to bulk biopharmaceutical production including facility design, procurement, construction, startup, and validation is preferred. Equipment acquisition and design engineering experience is desired. • Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.2011-11-01 22:17:20United StatesAmgenCalifornia12623BRCAThousand Oaks, CA24526977http://www.amgen.jobs/xml/24526977/jobUSAThousand OaksAuto req 12624BR Job Posting Title Sr Engineer - Process Equipment Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description • As a member of the Clinical Bulk Facilities & Engineering organization, this position serves as a project/plant engineer for facility systems and process equipment in a bulk biopharmaceutical manufacturing facility. Responsibilities include applying advanced engineering principles to the design and implementation of new equipment; providing operational support, troubleshooting, and optimization of assigned manufacturing process equipment; and directing and coordinating equipment maintenance to improve reliability. • This position serves as a lead or discipline engineer for capital projects. This role involves the application of advanced process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should understand engineering processes from initial conceptualization through project turnover to operations. • Ensures the logical, systematic translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements. • Desired skills include demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices; ability to apply knowledge of engineering principles and practices outside of discipline expertise to a broad variety of assignments in related fields; and ability to employ advanced techniques within area of engineering expertise. • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. • Supports system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts (including identifying cycle reduction time opportunities, efficiency gains, and yield enhancement opportunities). • Lead technical root cause analysis, incident investigations, and troubleshooting on equipment (mechanical, electrical, instrumentation and control system problems). Previous formal training and/or demonstrated experience is preferred. • Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.) • Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of experience directly related to the job OR Bachelor’s degree & 5 years of experience directly related to the job OR Associate’s degree & 10 years of experience directly related to the job OR High school diploma / GED & 12 years of experience directly related to the job Preferred Qualifications • Master’s degree in Chemical Engineering or Bioengineering preferred • 8+ years of relevant work experience with 7+ years experience in operations/manufacturing environment • Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.) is critical. Detailed understanding of industry regulations and ability to interpret in establishing current practices. • Direct experience in equipment engineering and troubleshooting with fermentors, bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems. • Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization. • Ability to apply advanced and diverse engineering principles to the design and implementation of major system modifications, introduction of new processes, and capital projects. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. • Strong leadership, technical writing, and communication/presentation skills are required. • Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage. • Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformances, corrective and preventative actions, and validation practices. • Experience in design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation is preferred. Equipment acquisition and design engineering experience is desired. • Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.2011-11-01 22:17:12United StatesAmgenCalifornia12624BRCAThousand Oaks, CA24526976http://www.amgen.jobs/xml/24526976/jobUSABoulderAuto req 12441BR Job Posting Title Specialist IS Bus Sys Analyst Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - Colorado Location (City) Boulder Amgen Job Description The Center of Excellence (COE) Business and Application Support organization is responsible for supporting the business processes and application software being implemented through Amgen’s ERP Program. Business Analysts within this team must possess thorough knowledge of the processes within their area of specialization as well as a comprehensive understanding of the configuration associated with the specific SAP components that are used to enable these processes. The Specialist, IS Business System Analyst will be primarily responsible for providing business and application support of the production environment. The analysts will interact with members of the Client-Facing IS teams as well as with our Super Users and Business Partners. The analysts will also work directly with members of the COE’s Technical and Infrastructure team to assist with the resolution of technical incidents as well as the implementation of new functionality. The Business Systems Analyst will serve as a liaison between our Business Partners and the COE in the development of new application functionality. In this role, the Business Systems Analyst will be responsible for performing the analysis and design associated with new requirements. The Business Systems Analyst will collaborate with the Development organization to create functional and technical specifications and complete the necessary testing and documentation associated with these changes. The analyst will also work closely with the Computer System Validation group to ensure that all enhancements are implemented in a quality manner. Limited travel (5-10%) both within and outside the US is expected. Basic Qualifications -Doctorate degree OR -Master’s degree & 3 years of directly related experience OR -Bachelor’s degree & 5 years of directly related experience OR -Associate’s degree & 10 years of directly related experience OR -High school diploma / GED & 12 years of directly related experience Preferred Qualifications -2+ years experience operating within a validated systems environment (FDA, European Agency for the Evaluation of Medicinal Products, Ministry of Health, etc.). -2+ years of SAP project or production support team leadership role. -2+ years experience with storage and/or handling unit management. -2+ experience with IDOC interface. -Participation in 1 full ERP Implementation. -Basic knowledge of SAP’s ABAP programming language. -Basic knowledge of Tier 2 systems (I.e. MES). -Knowledge in SAP organization design and integration with FICO, SD LE, IM/WM. -Experience using document repository and change management tools such as: Sharepoint, EDMQ, ISM, and Solution Manager. -SAP Certification in modules within MM, PP. -Excellent verbal, written and interpersonal communication skills.2011-10-25 20:39:30United StatesAmgenColorado12441BRCOBoulder, CO24410997http://www.amgen.jobs/xml/24410997/jobUSAThousand OaksAuto req 12252BR Job Posting Title Senior Manager Corporate IT Audit Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen seeks an IS - Sr. Manager, Corporate Audit for our Thousand Oaks, CA office. This individual will demonstrate a high level of professionalism and the ability to manage multiple projects simultaneously. Other duties include: • Execute Annual Audit Plan (SOX and Non-SOX) as approved by the Audit Committee • Provide leadership, guidance and coaching to audit staff in the execution of the Audit Plan and to achieve audit goals and objectives • Manage all internal reporting for the department, generating and supporting the development of standard and ad-hoc management reports • Support audit management in the preparation and development of executive presentations to the audit committee and executive management • Develop training programs for department including technical audit training, CPE certification, Six Sigma certification and professional career development • Assist directors, managers and staff of Amgen Corporate Audit, in providing independent, objective assurance and consulting services designed to add value and improve the operations of the Company • Participate in determining whether Corporate Audit’s process and document management systems, control and governance processes are adequate and functioning in a manner appropriate to a Company of our size and market • Interact with Amgen senior and mid-level management • Exercise sound judgment and initiative in handling business issues of significance to Corporate Audit and the Company • Assist on special projects as needed • Discharges responsibilities in a manner that is consistent with The Institute of Internal Auditors’ Code of Ethics, Standards for the Professional Practice of Internal Auditing and Statement of Responsibilities or Information Systems Audit and Control Association (ISACA). • Travel up to 25% per year Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree or & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Eight or more years of experience in finance, accounting or auditing • Eight or more years of experience in operations and project / change management • Four or more years of supervising staff or managing project teams • Bachelor's degree with an emphasis in accounting, finance, business administration, computer science, or in a life science related area • Advanced degrees / certifications such as CISA, CIA, CISSP, CISSM, CRISK, CGEIT, CPA and MBA is strongly preferred • External audit (e.g., Big Four) and /or internal audit (e.g., Fortune 500) experience is highly desirable • Working knowledge of enterprise applications such as ERP (SAP) systems, COSO framework and good audit experience of auditing ITIL, COBIT and other technical IS processes area a plus • Other desired experience in data management, data loss prevention, data security and classification • Self-starter with excellent project management and communication skills (both verbal and written), including the ability to effectively and confidentially interact with Amgen senior management • Excellent and insightful financial, analytical, interpersonal, team-building, leadership and conflict resolution skills • Proficient in Microsoft Word, Excel, and Power Point • Pharmaceutical / biotechnology industry experience is desirable2011-09-29 09:13:12United StatesAmgenCalifornia12252BRCAThousand Oaks, CA23915639http://www.amgen.jobs/xml/23915639/jobUSABoulderAuto req 12161BR Job Posting Title Specialist IS Bus Sys Analyst (Warehouse Management and Serialization) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - Colorado Location (City) Boulder Amgen Job Description The Center of Excellence (COE) Business and Application Support organization is responsible for supporting the business processes and application software being implemented through Amgen’s ERP Program. Business Analysts within this team must possess thorough knowledge of the processes within their area of specialization as well as a comprehensive understanding of the configuration associated with the specific SAP components that are used to enable these processes. The Specialist, IS Business System Analyst will be primarily responsible for providing business and application support of the production environment. The analysts will interact with members of the Client-Facing IS teams as well as with our Super Users and Business Partners. The analysts will also work directly with members of the COE’s Technical and Infrastructure team to assist with the resolution of technical incidents as well as the implementation of new functionality. The Business Systems Analyst will serve as a liaison between our Business Partners and the COE in the development of new application functionality. In this role, the Business Systems Analyst will be responsible for performing the analysis and design associated with new requirements. The Business Systems Analyst will collaborate with the Development organization to create functional and technical specifications and complete the necessary testing and documentation associated with these changes. The analyst will also work closely with the Computer System Validation group to ensure that all enhancements are implemented in a quality manner. Limited travel (5-10%) both within and outside the US is expected. Basic Qualifications -Doctorate degree OR -Master’s degree & 3 years of directly related experience OR -Bachelor’s degree & 5 years of directly related experience OR -Associate’s degree & 10 years of directly related experience OR -High school diploma / GED & 12 years of directly related experience Preferred Qualifications -24x7 on-call support is necessary to resolve critical business & technical incidents. -5+ years experience in performing SAP configuration within the MM/Procurement/WM Modules, including experience with PP integration. The successful candidate will also possess a thorough understanding of the business processes enabled by these SAP components. -3+ years experience performing systems analysis, design and translating business requirements into functional and technical specifications. -2+ years experience operating within a validated systems environment (FDA, European Agency for the Evaluation of Medicinal Products, Ministry of Health, etc.). -1+ years experience implementing RF for warehouse transactions -1+ year of AII/OER experience. -2+ years of SAP project or production support team leadership role. -2+ years experience with storage and/or handling unit management. -2+ experience with IDOC interface. -Participation in 1 full ERP Implementation. -Basic knowledge of SAP’s ABAP programming language. -Basic knowledge of Tier 2 systems (I.e. MES). -Experience using document repository and change management tools such as: Sharepoint, EDMQ, ISM, and Solution Manager. -SAP Certification in modules within WMS, MM, LE. -Excellent verbal, written and interpersonal communication skills.2011-09-16 22:30:02United StatesAmgenColorado12161BRCOBoulder, CO23674745http://www.amgen.jobs/xml/23674745/jobUSAThousand OaksAuto req 11636BR Job Posting Title Dir Information Systems Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Director Information Systems will act as the Operations Information Systems (OIS) leader supporting the Manufacturing of the Future initiative to include building of new manufacturing sites as well as modifications of existing facilities. Responsibilities Include: • Leading the application and evolution of Amgen Operations Information Systems S95 blueprint and technical architecture to the manufacturing of the Future facility requirements. • Accountability for delivering the OIS work streams in alignment with the larger program and Amgen IS organization. • Will form and manage strong relationships and work collaboratively with multiple areas across the enterprise to communicate, govern, and deliver the IS scope. • Providing technical & program/project leadership to the project teams in all project phases (design, delivery, startup, commissioning, validation and operational support) as well as IS project manager oversight to ensure the program/project budget, schedule and staffing is commensurate to enabling the manufacturing automation and information systems to attain the performance standards required to support the business objectives. • Influencing the development of business area strategy where appropriate. • Strong program / project management and leadership skills, including but not limited to the following: client interfacing and resolution of client concerns, developing and reporting project results, technical guidance of a project from concept to delivery, detailed project planning, vendor/contract management, system commissioning and validation, technical solution evaluation, schedule tracking. Basic Qualifications - Doctorate degree & 4 years of directly related experience OR - Master’s degree & 8 years of directly related years OR - Bachelor’s degree & 10 years of directly related experience AND - 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications - Demonstrated working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and will direct efforts of automation & Information Systems integrators, vendors, contractors, and Amgen teams in the successful execution of efforts by using appropriate development methodologies to establish a Process Automation System, Manufacturing Execution System, IT infrastructure, and Systems and Data Integration that meets Operations' business requirements. - Demonstrated working knowledge on automation systems & manufacturing information systems in cGMP regulated environments, FDA cGxP and 21 CFR Part 11 regulations, software development lifecycle and system validation. - Direct experience with Shop floor Automation systems (DCS, PLC/SCADA, BAS), MES systems, Manufacturing IT infrastructure, and Plant Systems & data integration, and Information Management required. Experience with Emerson DeltaV, Rockwell PLC/SCADA/Batch, OSIsoft PI data historian, Werum PAS/X, MES and BMS is preferred. Experience in other areas of Information Systems supporting manufacturing business unit is a plus. - Demonstrated working knowledge of enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering. - ERP experience is a plus.2011-09-15 19:42:22United StatesAmgenCalifornia11636BRCAThousand Oaks, CA23645739http://www.amgen.jobs/xml/23645739/jobUSAThousand OaksAuto req 11901BR Job Posting Title Principal IS Architect - Data Architecture Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Providing easy access to accurate information is a key source of competitive advantage for Amgen. The Principal IS Architect - Data Architecture role will be responsible for identifying key challenges for easy data access, proposing a strategy for efficient data and information life-cycle management, and driving the execution of this data architecture strategy. This position will leverage existing project opportunities and/or initiating new efforts to make progress toward the target architecture and ensure the consistency of Amgen’s data, business intelligence and application strategies. Job Responsibilities • KEY RESPONSIBILIITY: Perform data modeling, data governance, and data architecture design. • Conduct interviews with business leaders and users to identify information challenges and pain points. • Work with IS and business clients to establish a vision and a target state of enterprise data architecture to address the information challenges and pain points. • Analyze business requirements to assess data implications and develop data lifecycle and integration management strategies • Partner with business users, Client-facing IS teams, project teams, architects, and technical leads to deliver the required information capabilities and utilize information capabilities. • Facilitate data management and data governance for information stakeholders • Provide leadership to the discipline of data architecture and mentor junior staff in the field of data and information architecture Basic Qualifications -Doctorate degree & 2 years of directly related experience OR -Master’s degree & 6 years of directly related experience OR -Bachelor’s degree & 8 years of directly related experience OR -Associate’s degree & 10 years of directly related experience OR -High school diploma / GED & 12 years of directly related experience Preferred Qualifications -Bachelors degree in Engineering, Information Systems or Computer Science -10 years experience in Data Architecture and Governance, Information Management Strategy, and Master Data Management Strategy -5 year experience in enterprise-scale database application design/development or enterprise-scale database management operations -Demonstrated knowledge and experience in Enterprise Architecture strategy and information integration strategies. -Knowledge of life science business process and data desirable -Strong problem solving and interpersonal skills; consulting experience desired -Excellent written, oral communication and influencing skills -Ability to work both independently and as a team member with personnel at all levels in the organizational hierarchy. -Deep technical expertise in data management and data modeling -Demonstrated knowledge and experience delivering projects to meet business needs.2011-08-24 20:15:19United StatesAmgenCalifornia11901BRCAThousand Oaks, CA23225778http://www.amgen.jobs/xml/23225778/jobUSASeattleAuto req 11647BR Job Posting Title Specialist System Administrator - VDI XenDesktop Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California United States - Washington Location (City) Seattle Thousand Oaks Amgen Job Description This position can be located in Seattle, WA or Thousand Oaks, CA. The primary responsibility of this position is to architect, setup and support a Virtual Desktop Infrastructure (VDI) for a large Enterprise. Candidate will be responsible to work with the desktop team to set up the images and applications needs based on changing business requirements. The Job responsibilities will also include evaluating new features and recommending the solutions to Management from time to time. Responsibilities will include management, oversight and direct support of specialized systems and applications. Job Responsibilities • Interface with customer, technology and business contacts to document customer challenges and requirements. • Provides Design, implement and optimize technology or process solutions to meet customer requirement for thin client computing. • Provides technical leadership for design and engineering engagements and for problem/performance issues resolution for all aspects associated with the VDI solution. • Responsible for ongoing management of VDI infrastructure. • Performs necessary systems maintenance in accordance with vendor best practices and Company change management policies. • Designs system migration architecture as required. • Responsible for runbook design, development, and ongoing updates. • Responsible for capacity planning and disaster recovery planning and design as applicable. • Provides ITIL process planning as applicable. • Recommend changes to procedures which result in operational optimization • Participate in Root Cause Analysis (RCA) reviews when applicable. • Rotational 24x7 On-Call Support Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • 5+ years as a Citrix/VDI/Virtualization Administrator • Experience in Design and implementation of Citrix XenDesktop Solution • Proven knowledge of virtualization technologies – VMWare, XenServer, HyperV • Proven understanding of XenApp, App-V or other like technologies • Experience in Citrix installation, application streaming, content redirection setup, ICA files creation, roaming profile management, and folder redirection. • Mid to senior level programming/scripting • Experience in installation and monitoring of Application Servers • Solid grasp of TCP/IP networking fundamentals. • Multiple years of experience in troubleshooting issues in a fast-paced high-availability production environments with an emphasis on remote "lights-out" management of systems. • Outstanding troubleshooting ability. • Certifications in related technologies • Experience with various MS based applications • Experience in Application Sequencing with App-v Remote location solutions with App-V Integration with Citrix Xendesktop / Xenapp • Experience Powershell scripting • Experience working in a regulated environment (Pharmaceutical industry) • Virtualization experience (VMware / Hyper-V/XenServer) • NetApp/SAN storage experience • Familiarity with SQL Databases or Messaging system solutions • Excellent data-driven problem solving and analytical skills • Experience leading large initiatives in multiple functional areas of a complex organization • Proven experience as part of a high performance team Ideal candidates should have experience in the life sciences area and is very comfortable with architecture, handling multiple projects and bringing a wealth of ideas on how to accomplish system management tasks for complex systems across multiple locations.2011-08-12 22:18:34United StatesAmgenCalifornia11647BRCASeattle, CA22999180http://www.amgen.jobs/xml/22999180/jobUSAThousand OaksAuto req 11568BR Job Posting Title Associate Engineer - Drug Delivery Systems Career Category Operations Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position reports into the Drug Delivery Systems (DDS) group under Global Drug Product and Device Development in Thousand Oaks. This position will be required to apply advance and diverse engineering principles to execute the proper design, qualification and implementation of devices, diagnostics and ancillary items utilizing associated systems such as documentation, equipment and processes. Basic Qualifications • Bachelor’s degree OR • Associate’s degree & 4 years of directly related experience OR • High school diploma / GED & 6 years of directly related experience Preferred Qualifications BS degree in Mechanical Engineering, or other Engineering/Life Sciences 3 years of experience in engineering specific to the device or biotech/pharmaceutical industry. 3 years experience with device design, production and validation Knowledge of device development, manufacturing and test equipment, injection molding, and material science is important to the position. The position requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment. Independent thinker with demonstrated skills working in teams or leading project teams.2011-07-29 19:29:32United StatesAmgenCalifornia11568BRCAThousand Oaks, CA22717361http://www.amgen.jobs/xml/22717361/jobUSAThousand OaksAuto req 5103BR Job Posting Title Senior Manager of Technical Accounting Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This key role in the Finance organization will work closely with Amgen's corporate development groups to provide accounting support related to licensing and other M&A transactions. The position will report to the Director, Technical Accounting and will also assist in providing thought leadership and current best practices surrounding technical accounting issues globally. Specifically, this role will: - Provide advice on the accounting treatment and structure related to all licensing and other M&A transactions - Ensure key stakeholders (including, but not limited to, the Chief Accounting Officer, leadership within Corporate External Reporting and Accounting Operations, and Amgen’s independent auditors) are aware of contemplated deals and the potential impact to Amgen. - Collaborate with different business functions and teams to perform accounting due diligence on potential transactions - Ensure optimization for all contract provisions related to ongoing accounting obligations such as reporting, royalties, audits, etc. - Compile opening balance sheet purchase accounting entries including the sourcing and management of any related purchase accounting valuation activities - Document conclusions on executed transactions in technical accounting memos. Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree or & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications The ideal candidate should have strong knowledge and experience in the application of U.S. generally accepted accounting principles (GAAP) especially as it relates to accounting for acquisitions, partnerships and licensing transactions. He/She will have outstanding communication capabilities and must be comfortable and confident dealing with all levels of management within the organization. - 7 plus years of progressive accounting / finance experience including corporate level public company experience - CPA and 4 or more years of Big 4 audit firm experience required - Strong written, verbal communication, and presentation skills are required - Detail oriented; strong business analytical skills - Positive attitude and a strong work ethic - Ability to work in cross-functional team environment - A person of the highest personal integrity - Pharmaceutical/Biotech experience a plus - Knowledge and understanding of International Financial Reporting Standards (IFRS) a plus. - Knowledge of business valuation methods and M&A experience a plus Personal Competencies - Integrity - Holds to well-articulated core values and expected behavior, and holds others to the same standard - Technical Knowledge - Deep knowledge of general accounting standards and the standards impacting areas critical to the Biopharmaceutical industry (manufacturing, research and development, revenue recognition, M&A, licensing, etc.). - Driving Results - Sets compelling goals and aggressive schedules for improvement while remaining flexible in a rapidly changing environment. Able to influence other functional areas in order to achieve results. - Communication - Is highly articulate; makes arguments, both written and oral, in a compelling and concise manner.2011-06-25 18:26:38United StatesAmgenCalifornia5103BRCAThousand Oaks, CA22025629http://www.amgen.jobs/xml/22025629/jobTURIstanbulAuto req 9039BR Job Posting Title Market Access Manager Career Category Government Affairs Employee Subgroup Salaried FT Country (State/Region) Turkey Location (City) Istanbul Amgen Job Description Responsibilities: • Develops and implements Amgen’s political engagement strategy with officials, regulatory agencies and key policymakers. • Directs projects and activities to create a favorable pharma environment • Monitors government initiatives/legislation, surveys impact on the organization and develops the organization's response to legislation • Represents the organization in front of key government officials and policymakers • Builds relationships with local authorities, regulatory agency heads and key policymakers • Enhances the organization's image among authorities Basic Qualifications University Degree Minimum 3 years of experience in industry Minimum 2 years of experience in a similar position Fluency in English, both oral and written communications Computer skills (MS Office programs) Preferred Qualifications Minimum 2 years in a big pharmaceutical company2011-04-01 23:13:07TurkeyAmgenNone9039BRNoneIstanbul, TUR20488398http://www.amgen.jobs/xml/20488398/jobUSASeattleAuto req 8552BR Job Posting Title Specialist Systems Administrator ( Backup Expert / Lead) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California United States - Washington Location (City) Seattle Thousand Oaks Amgen Job Description This position can be located in Seattle, WA or Thousand Oaks, CA. This senior backup administrator / architect position is part of the Storage & Backup team in Application Hosting Services within the Enterprise Services organization, and is responsible for supporting the enterprise backup environment for both NetBackup and NAS/SAN storage in a globally distributed environment. This role requires demonstrated senior level architecture development/oversight and data lifecycle management expertise to help design a comprehensive data lifecycle management service. In addition, responsibilities include L3 support of critical backup operations involving thousands of servers in multiple locations in a global environment, assisting with the design and implementation of the next generation backup service and the company’s data lifecycle management architecture and strategy, and serving as the SOX focal for the Data Protection Service. Functions (duties/accountabilities) include the following: Serves as a technical consultant in the area of IT Backup, Backup Compliance, Archive and Data Lifecycle Management. Reviews and ensures Backup policies support the company Records and Retention policies, and aligned with Industry Best Practices. Provide direction for installation, configuration and support of backup and Disaster Recovery environments. Troubleshoot problems and provides rotational 24x7 on-call escalation for support of production backup systems. Ensure proper alerting for the backup environment, backup jobs, and data replication are in place. Create and/or update documentation of Backup and Disaster Recovery environments and associated documented processes. Interact closely with management, engineers, application resources, Database Administrators, Windows and UNIX Administrators, and other architects to plan and support the environments and align with the backup group’s overall strategy and direction. Oversee backup provisioning, monitor systems, forecast future capacity demands, conduct performance tuning, system controls, and documentation; install, configure, upgrade and troubleshoot issues Manage and keep Disaster Recovery environment in sync with primary on a specified periodic basis so in the event of disaster, operations can be restored in approved timeframes. Automate backup processes with custom scripts, consolidate and upgrade systems. Design a self-service backup architecture that incorporates data management lifecycle services. Develop data life cycle management policies for the company. Define and report metrics, Critical Success Factors (CSF’s), and Key Performance Indicators (KPI’s) for the processes. Serve as the SOX focal in the area of backups for compliance purposes, and have a deep subject matter expertise regarding compliance in a regulated environment. Communicate and manage expectations of the users during the planning and rollout of changes to the Incident management tools and/ or process. Participate in regular incident review meetings to ensure incidents are being resolved promptly in order to minimize service outages. Interact and collaborate with site leads across the globe to develop / implement best practices for the backup and storage areas Basic Qualifications - Doctorate degree OR - Master’s degree & 3 years of directly related experience OR - Bachelor’s degree & 5 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications BS in Computer Science, Computer Information Systems or Computer Engineering Two (2) or more certifications in the following areas: backup, SOX and/or DR vendor certifications (EMC, NetApp, HP, NetBackup, CSOX, etc.). 5+ years or more as a backup lead engineer/architect (planning, designing, configuring and supporting large enterprise backup environments. Extensive domain knowledge and/or experience with Veritas NetBackup Administration, NetBackup Command Line, Quantum Tape Libraries, Bocada Enterprise Reporting, NetApp VTL devices, Data Domain De-Duplication Appliances, Quantum DXi, Iron Mountain Connected Backup (CDP), UNIX System Administration, Bare Metal Restores, BladeLogic and Systems Analysis/Design, Symantec eVault, NetApp SnapLock. Strong oral and written communication skills, excellent interpersonal skills, and the ability to interact well with multiple levels of management. Strong technical and analytical skills. Able to organize and schedule tasks, develop realistic action plans, and incorporate time constraints and task priorities. Ability to take initiative and work with minimum direction in a high demand environment. Works effectively as a team member and leads cross-functional teams. Demonstrated ability to present designs, service direction, and scorecard results to executive management. Advanced Microsoft Excel, Word, and PowerPoint skills aare highly preferred.2011-03-07 22:11:23United StatesAmgenCalifornia8552BRCASeattle, CA19982570http://www.amgen.jobs/xml/19982570/job