Amgen Jobshttp://www.amgen.jobs2012-02-22 12:25:30USAThousand 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 Masters degree and 6+ years of directly related experience OR Bachelors degree and 8+ years of directly related experience OR Associates 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 preferredUnited StatesAmgen2011-11-03 23:36:13CaliforniaCAThousand Oaks, CA24581799http://www.amgen.jobs/xml/24581799/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 Bachelors degree OR Associates 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.United StatesAmgen2011-07-29 19:29:32CaliforniaCAThousand Oaks, CA22717361http://www.amgen.jobs/xml/22717361/jobUSAThousand OaksAuto req 12973BR 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 Leader of Operations Information Systems (OIS) global Automation organization and direct the activity of others in internal and external reporting relationships. This position is based in Thousand Oaks, California. Travel at various times is anticipated to support globally distributed staff and automation portfolio execution. This position will be responsible for delivery of a global portfolio of Automation and IS systems in capital projects, setting global Automation strategy, and serve as the point Technical Authority for Automation at Amgen. This position will also be responsible for providing and advancing automation platform-specific practices and standards on systems architecture, software libraries, and system lifecycle management. The individual will have client executive relationship management responsibility with Amgen Corporate Engineering executives as primary client, as well as site business executives as stakeholders of the delivered systems and solutions. The candidate must be able to influence the development of business area strategy where appropriate. Responsibilities: The Director will manage a staff of Automation Engineers distributed globally across Amgen locations, in delivery of automation services utilizing and enhancing the Automation Global Delivery Model and Business Practice. The Automation portfolio spans across Amgen Process Development, Clinical, and Commercial 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. The individual will chair the Amgens Global Automation network through a cross site and cross functional team setting, and will participate in several Global Engineering forums representing the voice of Amgen Automation network. The individual will also oversee the program management of the IS sponsored Amgen Automation Long Range Planning and capital reinvestment, budgeting, and execution process requiring significant collaboration across sites and functions (IS, Engineering, Finance) as well as Investment Lifecycle Management capital request and approval coordination. The individual will also manage key strategic automation supplier relationships from both product and services side as required. Ensure compliance with Amgen and industry practices, policies, procedures, legal requirements and goals of project sponsors and approved methodologies with supporting documentation and monitoring. Basic Qualifications Doctorate degree & 4 years of directly related experience OR Masters degree & 8 years of directly related years OR Bachelors 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 Bachelors degree in Engineering, Information Systems, Computer Science or the Life Sciences Master's degree in Engineering, Information Systems, Computer Science or Business Administration (MBA) 15 + years experience providing process automation and information systems solutions and support to manufacturing organizations in the biotechnology or pharmaceutical industries. Candidates will have worked on automation systems and executed projects of small to large sizes in cGMP regulated manufacturing environments, preferably both in Bulk API and Formulation/Fill/Finish facilities, and will be knowledgeable regarding FDA cGxP and 21 CFR Part 11 regulations and understand software system validation. Candidate will have led project teams in all project phases (design, delivery, startup, commissioning, validation and operational support) as well as automation & IS program management & technical oversight to 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. 10 + years Experience with Rockwell Automation PLC/SCADA/Batch, Emerson DeltaV, OSIsoft PI Data Historian, Werum MES and Siemens BAS is preferred. Experience in other areas of Information Systems supporting manufacturing business units in IT infrastructure and business systems. Candidates must have demonstrated working knowledge and application of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards in successful execution of appropriate development methodologies to establish a PCS, BAS, and MES implementation and Systems Integration that meets Operations' business requirements. Candidates should demonstrate program management, project management & engineering 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, management of suppliers/contractors/Systems integrators/OEMs, system commissioning and validation, technical solution evaluation, schedule tracking. Ability to build and manage cohesive teams of employees and external business partners and operate across functional boundaries, both internal and external. Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans. Ability to enhance and apply corporate blueprint and standards using business drivers to local business needs and project requirements. Ability to develop, and present business cases, project plans, and updates to senior management. Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical, project management, and business expertise.United StatesAmgen2011-11-30 18:32:13CaliforniaCAThousand Oaks, CA25108701http://www.amgen.jobs/xml/25108701/jobUSAThousand OaksAuto req 12606BR Job Posting Title Engineer - Package Engineering 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 Package Engineering (PE) group under Global Drug Product and Device Development in Thousand Oaks, CA. 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, manufacturing fill/finish equipment and 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 for both large and small molecules product. 2) Write tests 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 PE 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 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) 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. Basic Qualifications Masters degree OR Bachelors degree & 2 years of directly related experience OR Associates degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience Preferred Qualifications MS in Packaging or Engineering 5 years of packaging/engineering experience with 2+ years within the Pharma/Bio industry 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 timelinesUnited StatesAmgen2011-10-27 21:54:51CaliforniaCAThousand Oaks, CA24457550http://www.amgen.jobs/xml/24457550/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 - Masters degree & 8 years of directly related years OR - Bachelors 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.United StatesAmgen2011-09-15 19:42:22CaliforniaCAThousand Oaks, CA23645739http://www.amgen.jobs/xml/23645739/jobUSAThousand OaksAuto req 12528BR Job Posting Title Engineering Projects Sr Mgr Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description As Part of the Global Capital Projects Management Group within Engineering, this Sr. Project Manager will be responsible for independently managing and overseeing complex capital projects involving the planning, design, reconfiguration or construction, of the company buildings, structures or equipment. This position will lead a team of engineering expertise leveraged from both in the company and industry, for unusually complex technical projects, to coordinate the implementation of highly innovative and ingenious solutions in support of Amgen infrastructure. Functions: Defines project scope, forms project team, develops project strategy, master schedule and spending schedule, for complex projects supporting the engineering, construction and start up activities for various facilities ranging from administration to laboratories (Biology, Process Development, Quality, Chemistry) cGMP manufacturing, Utility plants, warehouse and distribution centers. Determines project objectives, and interprets company policies Prepare project funding documents with scope, cash flow, schedule, and deliverables Motivate project teams to a successful outcome Leads engineering and contractor evaluation and selection process Sets up logistics system, including RFQs, bid selection materials management, invoice approval. Reviews and approves cost estimates, sets up check and balance system. Integrate complete team into planning and design reviews for IDP projects Frequent review of progress vs. schedule vs. cost with appropriate teams and provide regular updates to client and management Develops and manages multiple large contracts. Develop total cost of ownership for capital projects Establishes policies for major projects, interprets, executes, and recommends modifications to company-wide policies. Basic Qualifications * Doctorate degree & 2 years of directly related experience OR * Masters degree & 6 years of directly related experience OR * Bachelors degree & 8 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications * Experience in Pharmaceutical / Biotechnology industry * Lean Construction or other continuous improvement methodology experience * Experience in Lifecycle Cost Analysis Demonstrated Competencies: Extensive experience in the application of project management skills and concepts with a critical understanding of related engineering disciplines Leadership experience with a diverse team of technical engineering and facilities management with an organization in the Pharmaceutical / Biotechnology industries Demonstrate practical ingenuity with the ability to problem solve using practical solutions Possesses internal personal skill to interface with technical scientific and management internal user groups Ability to prioritize multiple tasks and conflicting priorities across a broad range of facilities and engineering disciplines Excellent people skills featuring a demonstrated supervisory style that fits within the Amgen culture and values Interpersonal and facilitation skills necessary to forge consensus among competing clients interests on critical and time-sensitive issues--important in ensuring that, within Amgen's collaborative culture, projects are finished on time and on budget. Often acts independently to uncover and resolve issues associated with the development and implementation of processes or procedures. Strong analytical skills in the information and communication technologies Ability to work independently and collaboratively Ability to tactfully negotiate and positively influence peers and executive leadership Effective oral, visual and written communication skills with the ability to listen effectively Resilience & flexibility with the ability to react to changes quickly, and the ability to apply knowledge to new problems and new contextsUnited StatesAmgen2011-10-27 21:54:43CaliforniaCAThousand Oaks, CA24457522http://www.amgen.jobs/xml/24457522/jobUSAThousand OaksAuto req 12632BR Job Posting Title Regulatory Affairs Sr Mgr (Global Labeling) 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 facilitate the development and maintenance of drug product core labeling documents that are consistent with regulatory requirements, corporate strategy and Amgen values. Provides quality labeling documents for health authority submissions that reflect regulatory standards and key stakeholder contributions and permit the best possible patient and company outcomes. Facilitates and records/tracks labeling reviews and issue resolution. Ensures that labeling documents are accurate, current, consistent, comprehensive, and competitive with other agents in the class. Job Summary: - For development products: Provides strategic and tactical guidance to product strategy teams following the concept of Label drives development and builds the evidence based development Core Data Sheet (dCDS). - For marketed products: Leads product-specific global labeling development and maintenance activities throughout a products life cycle. Key Activities: - Evaluates development strategy impact on target product labeling - Identifies and analyzes regulatory requirements and competitive labeling - In collaboration with the product strategy team, builds the evidence-based label and labeling strategies for the product(s) - Leads cross-functional teams in the development and maintenance of TPLs, dCDSs, CDSs, USPIs/PPIs/MGs/DHCP letters and Global Negotiation Documents (GNDs) - Facilitates the corporate review and approval activities for CDS and regional labeling, including regional deviations from the CDS - Ensures alignment of labeling strategy across products - Collaborates with other Product Leads and functional area representatives to ensure adherence to established Amgen processes and corporate standards - Coordinates corporate review and approval of cross-product issues within the scope of assigned products/franchises at the discretion of Director - Facilitates implementation discussion of FDA approved product labeling - Creates and maintains cumulative annotated labeling history documents for assigned products/regions - Collaborates with regional affiliates and Business Partner representatives in the development and maintenance of regional drug product labeling - Manages labeling commitments for Business Partners as delineated in partnership/service agreements - Maintains awareness of regulatory legislation pertaining to labeling and assesses and communicates its impact on the business and products of the company - Reviews and assesses impact of draft legislation; provides input on Amgen/industry comments - May be responsible for mentoring and developing direct reports Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Masters degree & 6 years of directly related experience OR - Bachelors degree & 8 years of directly related experience OR - Associates degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - Business expert of Amgens global labeling process, including stakeholders, accountabilities, and cross-functional teams; knowledge of regulatory requirements and standards that govern drug product labeling and: - Attention to detail - Recognize and escalate issues - Time Management - Written and Verbal communications - Planning - Organizational Skills - Problem Solving - Customer Focus - Building Effective Teams - Managing and Measuring Work - Presentation Skills - Interpersonal Skills - Process Management - Conflict Management - Meeting Facilitation/Negotiation Skills - Motivation Skills - Global Business Knowledge - Strategic Agility - Microsoft suite Outlook, Word, Excel, PowerPoint - Technical competency of data entry into corporate Labeling Process Tracker (LPT) and corporate labeling document management system (EPIC)United StatesAmgen2011-11-08 19:30:40CaliforniaCAThousand Oaks, CA24753733http://www.amgen.jobs/xml/24753733/jobUSAThousand OaksAuto req 13409BR Job Posting Title Sr Project Manager - Manufacturing of the Future (MoF) Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description You will be working as the end user representative responsible for establishing, leading and managing the user requirement development and implementation of Amgens Manufacturing of the Future (MoF) S95 blueprint architecture. 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: Leading the user requirement development and supporting the evolution of Amgen Operations Information Systems S95 blueprint and technical architecture to the manufacturing of the Future facility requirements. Accountable for providing strategic and tactical guidance to enable the execution of manufacturing automation and information systems to attain the performance standards required to support the business objectives Manage multi-disciplinary project execution with the development of clearly articulated scope and quantifiable business benefits Strong program / project management and leadership skills requiring strong collaboration and coordination between client and implementation teams to deliver on project objectives Basic Qualifications Doctorate degree and 2 years of directly related experience OR Masters degree and 6 years of directly related experience OR Bachelors degree and 8 years of directly related experience OR Associates degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications 5+ years within or supporting clinical or commercial manufacturing facilities Advanced degree preferred in science, engineering, or business (MBA). 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 management Demonstrated working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and will be able to interface with the automation & Information Systems teams to provide clear Operations business requirements to support the successful project execution. 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 and quality units are a plus (TrackWise, LMS, Maximo, LIMS) Demonstrated working knowledge of enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering.United StatesAmgen2012-01-18 21:54:24CaliforniaCAThousand Oaks, CA25968550http://www.amgen.jobs/xml/25968550/jobUSAThousand OaksAuto req 13402BR Job Posting Title Legal Coordinator Career Category Administrative 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 Associates degree & 2 years of directly related experience OR High school diploma / GED & 4 years of directly related Preferred Qualifications - Outlook, Word, Excel and PowerPoint experience are preferred - Associates degree is preferred - prior law firm or in-house law department experience preferredUnited StatesAmgen2012-01-11 20:37:04CaliforniaCAThousand Oaks, CA25834400http://www.amgen.jobs/xml/25834400/jobUSAThousand OaksAuto req 13567BR 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 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 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 Units 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 Regulatory CMC - 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 - Masters degree & 6 years of directly related experience OR - Bachelors degree & 8 years of directly related experience OR - Associates degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - 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 packages - CMC-specific regulatory knowledge and experience - Ability to understand and communicate scientific information - Ability to anticipate and prevent potential issuesUnited StatesAmgen2012-01-25 21:04:29CaliforniaCAThousand Oaks, CA26111457http://www.amgen.jobs/xml/26111457/jobUSAThousand OaksAuto req 13647BR Job Posting Title Contracts & Pricing Senior Manager Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position will provide critical cross functional support for the Nephrology Pricing Team as well as other cross BU projects on an as needed basis. The core focus will be on providing close support to key business unit stakeholders including developing appropriate pricing and/or contracting strategies and executing associated tactical implementation plans. Other job responsibilities will include developing plans to support Amgen's longer term Pricing Strategy and providing Sr. Management with recommendations and updates. Applicants must have a strong track record of strategic thinking and successful implementation of initiatives within a pricing, business development, market research or other analytic business support function within the Biotech or Pharmaceutical industry. Key job responsibilities will include, but are not limited to: Understand pricing and contracting questions or ideas that our internal customers in the Business Units have Conduct appropriate analyses and develop pricing and contracting recommendations that influence decision-making of senior leadership at the Executive Director, VP GM, and SVP levels Executes assigned pricing analytic projects to support NACO business units. Responsible for all contract-related activities for assigned areas, review of contract performance, problem resolution on existing contract. Development of complex analytical models to support contracting strategies and support recommendations. In addition, to the evaluation and Q.A of all analytical models developed among team members including LEDR discount forecast models and the ASP forecast models, while insuring best practice across the team Provide recommendations and administrative support to Pricing Management and business unit relating to the design and implementation of new contract programs. Interpret and apply regulations associated with relevant legal issues (i.e. Robinson-Patman, Discount Safe harbor, Fraud and Abuse and general contract law). Evaluate contract modifications and work with contract writers and Legal to develop suitable contract language. Interface with Legal, Marketing, Business Units, Sales Management and external customers to ensure appropriate identification and evaluation of accounts. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree or & 8 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications 6+ years experience solving complex business problems and managing analytics projects. Internal Amgen experience or experience in pharmaceutical/biotech environment preferred Demonstrated track record of increasing responsibility and leadership experience Excellent project management skills and capacity to manage/lead multiple projects. Successful candidates must possess the ability to work with clients within Corporate Pricing, the Amgen Sales Force, Amgen Business Units, Legal, and Finance. The candidate must be an effective communicator and demonstrate success in a matrix environment both as a leader and member of cross-functional teams. This position requires good judgment and initiative in handling business issues of significance to Corporate Pricing. The candidate must have ability to successfully manage multiple projects with varying priorities. A strong background in contracting, finance, sales, or marketing is preferred. Candidate must possess strong verbal and written skills and be comfortable with presentations to Senior Management. Excellent interpersonal and communication skills are required as well as proven project management skillsUnited StatesAmgen2012-01-25 21:04:12CaliforniaCAThousand Oaks, CA26111447http://www.amgen.jobs/xml/26111447/jobUSAThousand OaksAuto req 13417BR Job Posting Title Category Mgr - Program Management of Operations Productivity program Career Category Procurement Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Category Manager resides in Global Strategic Sourcing (GSS). Reporting to the GSS Director, the Category Manager will initially be responsible for Program Management of Operations Productivity program, conducting supplier risk assessments and strategic sourcing and ongoing supplier management of containers for drug substance. Working within a matrix environment, the Category Manager will be responsible for portfolio management to drive financial and Total Cost of Ownership (TCO). Work with cross site Operation sourcing team to seek out opportunities and address challenges. It will also involve management reporting to Senior Leadership in Sourcing and Finance along with Operations. The Category Manager will lead the Supplier Risk assessments for GSS related to supplier quality, business, and technical capabilities during process development states and commercial support. This involves working with other category managers to collect, analyze and assimilate data while looking for process efficiencies. Finally the category manager will employ category management tools to deliver on strategic sourcing initiatives. This includes conducting business opportunity analysis, make/buy analysis, data analysis requirements gathers, development and executing of RFx, sourcing strategy development, implementation, and contract development negotiation. Skills: Financial Analysis Data Analysis & Reporting Critical Thinking Collaboration in Virtual Environments Influencing Skills Reporting Skills Basic Qualifications Doctorate degree OR Masters degree & 3 years of directly related experience OR Bachelors degree & 5 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications MBA preferred 3+ years of Strategic Sourcing experience 2+ years Biotech/Pharmaceutical experience 5+ years experience in a complex business environment Certified Purchasing Manager (CPM), Project Management Professional (PMP), and/or Green/Black Belt Six Sigma certification 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 anticipate problems requiring evaluation of intangible variables 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 identify roadblocks and effectively identify and execute resolution 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 Significant success as a leader in primary pharmaceutical drug product packaging, drug product delivery, critical raw material and /or medical device developmentUnited StatesAmgen2012-01-20 21:29:45CaliforniaCAThousand Oaks, CA26014206http://www.amgen.jobs/xml/26014206/jobUSAThousand OaksAuto req 11478BR Job Posting Title Principal IS Bus Sys Analyst (Testing COE) 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 Systems (IS) Testing Center of Excellence team within IS Applications Services Solution Development and Testing and will be responsible for managing the testing lifecycle of application systems as part of project/program teams. The successful candidate will be the IS Test Manager for large, complex, global initiatives and will partner with IS management, IS Project Managers, IS Business Analysts, IS Tech Leads, and project stakeholders to drive IS testing standards, execution, and the adoption of testing tools. Travel requirements may vary as they depend upon specific project assignments. Key Responsibilities - testing team and project team - Maintain and build client relationship - Accountable for all testing deliverables - Authors Test Plan document - Strong analytical skills to understand the business process and the system under test - Effectively, efficiently, and creatively achieve departmental business objectives by proactively prioritizing and utilizing testing resources, including time, staff, vendors and budget - Responsible for testing strategy and testing resources - Tracks respective testing progress and status - Provide testing and defect metrics - Assesses progress and effectiveness of test effort - Manages creation and quality of test deliverables - Tracks defects and monitors the workflow. Reviews and closes/defers defects. - Reviews requirements traceability (from test scripts to requirements) - Manages the testing team for assignments and issues - Proactively identify critical testing issues and changes necessary for success of project Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Masters degree & 6 years of directly related experience OR - Bachelors degree & 8 years of directly related experience OR - Associates degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - Masters or Bachelor's Degree in Computer Science, Software Engineering, MIS, or other computer-related majors. - Outstanding written and oral communication and presentation skills, including the ability to set managerial context for complex issues - Broad communications experience with depth in internal communications and change management - Demonstrates knowledge of database, web, system design, network and hardware fundamentals - Experience in HP Quality Center tool - Knowledge of Software Development Lifecycle, UML, Agile and RUP - Experience working in a regulated industry, preferably pharmaceutical industry - Strategic, data driven approach to communications and program development - Strong business acumen - Track record of coaching leaders to communicate effectively - Excellent command of English; proficiency in other languages an advantage - Ability to work cross-functionally and globally in a fast-paced environmentUnited StatesAmgen2011-11-16 22:43:20CaliforniaCAThousand Oaks, CA24910894http://www.amgen.jobs/xml/24910894/jobUSAThousand OaksAuto req 12756BR Job Posting Title Strategy Dir Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Director will identify key corporate strategic issues for analysis, respond to project requests from senior Amgen executives, and supervise / execute project work quickly with high quality results. In doing so s/he will structure the issues and analyses, manage work over one or more project teams, interact with a wide range of key constituencies inside (Finance) and outside of Amgen (consultants), and prepare and present findings to executive management. The Director is also expected to have a broad perspective on the pharmaceutical and biotechnology industries as well as companies, technologies and therapeutic areas of interest to Amgen. From time to time, s/he will partner with other functions in the Strategy and Corporate Development group. Key Responsibilities Lead and manage cross functional initiatives while delivering high-quality and timely results Conduct project scoping, chartering, execution strategy, process improvement activities, and change management Serve as primary interface with sponsors and interact with personnel in all areas of the company Recruit, train, and develop staff About Amgen and the Strategy and Corporate Development Team Amgen is a Fortune 500 company and a leader in the biotechnology industry. For more than 25 years, the company has tapped the power of scientific innovation to advance the practice of medicine and to help patients fight serious illnesses. We currently have an opportunity for a Director in the Strategy and Corporate Development team. The group executes high priority initiatives focused on increasing Amgens competitive position, improving productivity, and delivering economic value. Basic Qualifications Doctorate degree & 4 years of directly related experience OR Masters degree & 8 years of directly related years OR Bachelors degree & 10 years of directly related experience Preferred Qualifications Doctorate or Masters degree in finance, business, science, and / or technology 10+ years experience in finance, biotechnology / pharmaceutical development and / or top tier Management Consulting and / or Investment Banking firms 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 Excellent conceptual problem solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution Strong influencing skills with a demonstrated ability to influence different styles Proven experience as a member and leader of a high performing team Proven leadership skills and organization management experience Experience developing and mentoring staffUnited StatesAmgen2011-11-16 22:43:09CaliforniaCAThousand Oaks, CA24910890http://www.amgen.jobs/xml/24910890/jobUSAThousand OaksAuto req 12983BR Job Posting Title Process Improvement Senior Manager Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Process Improvement Senior Manager is a global-role based in Amgen's Global Development Operations (GDO) organization, and reports to the head of Development Operations Performance Management Services (DOPMS) Process Improvement group. The role will help drive continuous improvement projects that deliver measurable gain in cost, quality and/or cycle time within GDO and for the Center of Development Excellence (CODE). The role will support global standard trial execution process design and redesign based on emerging needs of the business (e.g., study start-up, data collection, study close-out). The role will be responsible for the following: - Managing the development and implementation of optimized business processes, process improvement, knowledge management and change initiatives. - Evaluating and managing the impact of process changes to functions, systems and other related processes both upstream and downstream -Partnering to monitor appropriate clinical operations benchmark data and/or internal metrics to measure process improvement - Maintaining alignment of process and change improvements with other current and development GDO processes. - Facilitating communication of information on project status, changes, and issues to team members - Leveraging Amgen process improvement tools and methods Basic Qualifications Doctorate degree & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree or & 8 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications BA/BS/BSc in the sciences 9 years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical product development (clinical research or clinical operations experience obtained at a biotech, pharmaceutical or CRO company) Previous management experience of direct reports, including management level staff Knowledge Extensive clinical trial execution knowledge with understanding of other functions, including Pre-Clinical, Clinical, Development Operations, and Regulatory Project management tools and processes (e.g., MS Project, PowerPoint, Visio) Strong computer literacy, including word processing, presentation and spreadsheet applications Key Competencies Able to lead cross-functional teams in the successful completion of major, complex programs Able to influence and motivate others outside of direct line of authority Able to navigate through a complex team or matrix environment Effective meeting management Strong facilitation, negotiation and conflict resolutions skillsUnited StatesAmgen2012-01-14 19:10:36CaliforniaCAThousand Oaks, CA25904452http://www.amgen.jobs/xml/25904452/jobUSAThousand OaksAuto req 11438BR Job Posting Title Dir Capital Projects Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Engineering Global Capital Projects Director is responsible for the leadership, guidance, growth and development of Amgen's Thousand Oaks Global Project Management group. The ECPD will leverage engineering expertise both in the company and industry to optimize Amgens assets throughout their life-cycle, from planning, design, construction, operations, and maintenance in support of Amgen infrastructure. Functions: Develop and manage processes and guidelines to support the design, construction and start-up and operation of complex facilities such as cGMP manufacturing facilities, laboratories (Biology, Chemistry, Process Development, Quality, etc), utility plants, warehouse and distribution centre, site infrastructure, administrative buildings, etc. Manage overall Program / Project portfolio deliverables and schedule. Establish and maintain program drivers and incorporate necessary changes. Interface with all levels of Executive Management to team members. Mentor and develop high performing team and talent within organization. Motivate and focus small, medium and large project teams. Prioritize multiple tasks and conflicting priorities across a broad range of facilities and engineering disciplines. Interface with technical, scientific and management internal user groups. Provide technical problem solving skills involving sites and functions within the corporation. Develop the correct contracting strategy appropriate for successful outcome Develop life cycle cost models for specifications and guideline. Manage small, medium to large, complexity projects supporting the engineering, construction and start up activities for G&A or Manufacturing facilities. Forge consensus among competing clients interests on critical and time-sensitive issues--important in ensuring that, within Amgen's collaborative culture, projects are finished on time and on budget. Other tasks and Duties as assigned. Demonstrated Competencies: * Possess strong leadership and management skills. * Strategic thinker with strong Business acumen. * Strong technical and business problem solving skills. * Firsthand knowledge of the inter-relationship between various corporate processes and function. * Excellent people skills featuring a demonstrated supervisory style that fits within the Amgen culture and values. * Knowledge of regulatory requirements, experience in participating with Regulatory Agencies. Basic Qualifications * Doctorate degree & 4 years of directly related experience OR * Masters degree & 8 years of directly related years OR * Bachelors 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 Engineering, Professional registration, such as a Professional Engineer license 5 + years engineering experience in biotech/pharmaceutical industry supporting manufacturing, clinical, process development and quality Understands operational aspects of BioPharm and/or engineering industries Strong communication, relationship building, leadership and mentoring skills Proven ability to manage in a highly fluid, interactive environment. Ability to travel up to 20% including overnight stays.United StatesAmgen2011-10-06 20:41:39CaliforniaCAThousand Oaks, CA24084952http://www.amgen.jobs/xml/24084952/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 Amgens 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 Amgens 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 Masters degree & 3 years of directly related experience OR Bachelors degree & 5 years of directly related experience OR Associates 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 ethicUnited StatesAmgen2011-11-29 18:32:37CaliforniaCAThousand Oaks, CA25085030http://www.amgen.jobs/xml/25085030/jobUSAThousand OaksAuto req 13612BR Job Posting Title International Government Affairs Director, Asia Pacific/Japan (Based in Thousand Oaks, CA) Career Category Government Affairs Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Lead government affairs strategy in Asia Pacific, China/Japan. Direct, enable and support IGA team on strategy development and execution in responsible markets Lead government strategy on Amgen business development and support of MIP goal Serve as lead IGA for partnerships with GV&A, MB&O, R&D on regional government issues Partner with IGA VP on Integration of Communications, Policy, Biosimilars and Advocacy in planning for responsible markets Engage Washington DC IGA team on government issues and actions Provide hands on support to Asia Pacific, Japan Markets Lead government engagement for Amgen senior executives when visiting responsible markets Hands on support of political access / lobbying campaigns in responsible markets Develop toolkits for staff and lead on messaging for responsible markets Responsible for relations with government consultants for Asia Pacific, Japan Drive Amgen engagement with trade groups on country specific issues in Asia Pacific, China/Japan Basic Qualifications Doctorate degree & 4 years of directly related experience OR Masters degree & 8 years of directly related years OR Bachelors degree & 10 years of directly related experience Preferred Qualifications Strong business acumen and commercial understanding University degree or equivalent in government affairs or international trade/relations Excellent command of the English language, both orally and in written form, foreign language a plus. Deep experience in working in Asia Pacific, China, Japan or across multiple cultures a requirement. Mature business person who has experience in delivering on government affairs for pharmaceuticals in international markets Government and industry savvy outlook and good understanding of policy with commercial and business issues gained from years of experience in the pharmaceutical or biotechnology industries Experience leading on trade associations and business councils Understands trends in the environment and has a strong understanding of government reimbursement systems Has experience in leading cross-functional projects Has experience being the COO of a team Competencies To be successful in this role requires the ability to: Leader v. manager; avoids over managing and under leading. Has an appreciation for cultural diversity Motivates and empowers employees to similarly build relationships to be successful Systematically establishes conditions for high performance teamwork based on the requirements of the situation Successfully demonstrates strategic thinking and agility in response to current and future needs Consistently links internal strategies to external trends and developments Can connect the dots from one area to another, and makes concrete suggestions on improvements and integrations Demonstrates strong and realistic confidence in oneself in challenging situations and maintains a calm focus on results over time. Models and promotes the companys key values and expectations in a systematic and proactive way Has a strong to drive to accomplish the task at hand and is able to prioritize work effectively Is able to work in a matrix with people from many different fields and has the ability to bring all of them together to function effectively Strong skill sets are required in the following areas Excellent communication skills with the ability to efficiently and productively communicate orally and in writing Focused-supports positions with hard data Possesses sound judgment and is an innovative thinker Excellent cross-functional style Act as a role model for others in line with Amgen values Can easily translate strategy and activities into business value added metricsUnited StatesAmgen2012-01-30 23:42:38CaliforniaCAThousand Oaks, CA26200955http://www.amgen.jobs/xml/26200955/jobUSAThousand OaksAuto req 13629BR Job Posting Title Undergrad Intern - Metabolic Disorders Research Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgens Metabolic Disorders Research department at our Thousand Oaks headquarters is looking for an undergraduate student interested in a 10 12 week internship to serve in a supportive role in a basic research lab within the Metabolic Disorders Therapeutic Area (TA). The individual will work with a Scientist and Sr. Associate Scientist to support basis research around drugs to control serum mineral metabolism (calcium, phosphorous), urinary protein, markers of renal damage and phosphaturic hormones (e.g., parathyroid hormone). Markers of cardiac damage and protection may also be assessed. The student will apply in vitro, ex vivo, and in vivo techniques to determine the effects of therapeutic drug/protein candidates to protect and/or recover from renal and related cardiac insults. The intern will also have the opportunity to learn about the basic biology pertinent to disease-related research that is designed to help patients fulfill unmet medical needs. The Intern will provide assistance needed to conduct experiments and collect data that requires more effort than we currently have available and/or allocated. Intern availability would help our group collect additional data to complement ongoing/planned experiments. This should serve to support publications (abstract/manuscripts), advance understanding of small molecule and/or protein therapeutic targets and increase TA productivity. 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 currently pursuing and undergraduate degree in Biological/Biomedical Sciences, molecular/cell biology, pharmacology or toxicology 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 currently enrolled at an accredited four-year college or university as a full time student Must have completed at least one full year of study at the time of application 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 Candidate will have an interest or experience in hands-on laboratory bench work Excellent written, oral communication skills and ability to work under minimum supervision. Working knowledge of Excel, PowerPoint, statistical/graphing programs would be a plus. The intern should be able to work within the specified timelines and have good interpersonal skills. The intern should be meticulous in basic laboratory procedures and should be able to pay close attention to details and procedures. The intern should be able to interact with individuals from various groups both within and outside of the assigned primary lab. Candidate should be familiar with preclinical animal research guidelines and acceptable practices.United StatesAmgen2012-01-30 23:42:27CaliforniaCAThousand Oaks, CA26200949http://www.amgen.jobs/xml/26200949/jobUSAThousand OaksAuto req 13700BR Job Posting Title Principal Systems Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen Job Description Successful candidate will participate in the development of delivery device systems. Scope will include wide range of devices including needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will work on establishing requirements for designing and developing delivery systems with high volume consumable components. The Principle Systems Engineer will work closely with members of the Product Development organization to translate high level product requirements into detailed engineering specifications, and system interface specifications which in turn support the design, development, validation, regulatory submission of these devices. The role of the Principle Systems Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Position Responsibilities Generate and manage interface control/design documents, device specifications, and system specifications. Develop and maintain device requirement traceability among related device and system requirements and specifications. Direct system function design and architecture to meet internal and external customer needs. Coordinate between various groups to ensure the device meets all requirements. Coordinate multi-product system level engineering testing. Develop and maintain system engineering processes and procedures to the latest industry standards. Monitor all system and subsystem hardware and software integration and acceptance testing. Generate, maintain, and track system and sub-system program schedules. Identify, evaluate, and track system and sub-system program risks and risk mitigations including technology, development, design interface, sub-system connectivity, and schedule. Direct internal cross-functional teams and contract manufactures or design firms to ensure system design, architecture, and verification/validation meets design input. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree & 8 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications BS in Engineering and previous experience in a medical device industry 10 years current experience with system engineering processes and procedures. Led projects from development through the 510k and PMA approval process. Broad understanding of software engineering methodologies including software verification and validation strategies. Familiarity with lean manufacturing and six-sigma methodology. Experience with DOORS, Requisite Pro, or other similar requirements management software. Familiar with the following standards: o US Good Manufacturing Practices 21CFR820 o Quality Management ISO 13485 o Risk Management ISO 14971 o EU Medical Device requirements Council Directive 93/42/EEC o Medical Electrical Equipment EN 60601 Small scale device assembly experience. Experience in model-based design and UML. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Strong problem solving, risk assessment, and risk management skills. Ability to converse technically with mechanical, electronic, software, and quality engineers. Must be capable of working on multiple projects in a deadline driven environment. Must have strong oral and written communication skills, decision making, presentation and organization skills.United StatesAmgen2012-01-30 23:42:04CaliforniaCAThousand Oaks, CA26200934http://www.amgen.jobs/xml/26200934/jobUSAThousand OaksAuto req 13707BR Job Posting Title Clinical Research Medical Director - Neuroscience 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 (Neuroscience Therapeutic Area) will be based at Amgen's Thousand Oaks, California headquarters and will report to the Executive Medical Director Global Development, Neuroscience Therapeutic Area. 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 Preferred Qualifications - MD plus accredited residency in Psychiatry or Neurology, 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) in the areas of neurology or psychiatry. 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 issuesUnited StatesAmgen2012-01-30 23:41:36CaliforniaCAThousand Oaks, CA26200923http://www.amgen.jobs/xml/26200923/jobUSAThousand OaksAuto req 13360BR Job Posting Title Marketing Director, Early Pipeline Planning, Oncology - Thousand Oaks, CA Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Early Pipeline Planning - Commercial Leader (GCL) Commercial representation in Early Product Strategy Team(s) to define commercial option space for early molecules (PST E2L Portal) and drive expected value based prioritization of early portfolio Develop Early Global Strategic Plan(s) by working closely with the other core functions represented on the Early Product Strategy Team(s), focus on Target Product Profile Drives the development of early portfolio strategy and priorities by working closely with Early PST members Represents commercial in early Licensing and M&A teams and activities Provide single commercial voice for all early pipeline issues to Therapeutic Area Steering Committee (TASC) and XRB. Includes the development of marketing input for portal decisions throughout the early commercialization process and development of commercial input for key documents. Basic Qualifications Doctorate degree & 4 years of directly related experience OR Masters degree & 8 years of directly related years OR Bachelors degree & 10 years of directly related experience Preferred Qualifications The candidate must be an excellent communicator, both in oral and written form, with strong demonstrated leadership skills. The successful candidate will also demonstrate the ability to think and operate strategically, as well as formulate, write and execute well-designed commercial strategies and plans. Frequent domestic and international travel will be required. Requirements for this position include a graduate degree (preferably in biology or medicine, post-graduate degree in science is preferred), 4-6 years of pharmaceutical and /or biotech marketing experience in oncology pipeline planning. Understanding of key cancer market trends and technologies, as well financial analytical, modeling capabilities are required. Some examples of experiences that increase competitiveness for this job are: Global pipeline planning Global Strategic Planning Leadership of cross-functional teams To be effective, this person will need to work in a very collaborative and productive way with the other major functions represented on Amgen's Early Product Strategy TeamsUnited StatesAmgen2012-01-09 21:26:35CaliforniaCAThousand Oaks, CA25783453http://www.amgen.jobs/xml/25783453/jobUSAThousand OaksAuto req 13376BR Job Posting Title Senior Manager, Strategic Planning and Operations, Latin America - Based in Thousand Oaks, CA Career Category Sales & Marketing Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position is based at Amgen's corporate headquarters in Thousand Oaks, CA and supports Amgens Latin America (LA) Region. This role will report to the LA Director of Strategic Planning and Commercial Operations. The main responsibilities of the role include: 1. Planning, coordinating cross functionally, and monitoring progress of product filings and launches associated with Tecnofarma, Amgens distributor in Argentina, Chile, Colombia, Venezuela, and potentially many other markets in LA. This includes building and maintaining a master plan in collaboration with all functions involved, facilitating project team meetings, and resolving issues. 2. As products launch, this role will support commercial activities on an ongoing basis. This includes leading product sales and volume performance analysis, ensuring timely communication of marketing materials, supporting the sales business review and budget process, developing insightful market analysis and revenue forecasts, and facilitating communication to Amgens executive leadership. 3. This role will also be involved in other aspects of distributor management including, but not limited to, supporting ad hoc requests from Tecnofarma, facilitating price analysis, assisting with the coordination of training programs, resolving other issues, etc. 4. Lastly, other projects will be assigned on an ad-hoc basis. The LA region is fast paced and an entrepreneurial spirit is key as we build the business! Basic Qualifications Doctorate degree & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree or & 8 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Direct work experience in the Latin America market is a plus MBA Preferred Minimum 6 years experience in biotech/pharma in Sales, Marketing, or Commercial Operations. We are looking for someone with business management experience as a Marketer, Commercial Operations lead, District Manager, and/or Sales Representative. This role requires a team-oriented player with a strong work ethic and an ability to handle/manage projects in a fast-paced environment. We desire a quick learner with an entrepreneurial spirit and a Commercial mind-set and with strong analytical, communication, project management, and Excel/PowerPoint skills. Competency/fluency with Spanish is strongly preferred. Additional preferred skills: Understanding of LA region and ability to drive sales Self starter. Autonomous individual Team player Ability to facilitate group discussion and meeting Excellent personal organization skill Proactive approach to problem solving Exceptional written and oral communication and presentation skills. Strong ability to present ideas and recommendations. Ability to deal with ambiguity and thrive in an entrepreneurial team Expert fluency in use of PowerPoint and ExcelUnited StatesAmgen2012-01-09 21:26:22CaliforniaCAThousand Oaks, CA25783444http://www.amgen.jobs/xml/25783444/jobUSAThousand OaksAuto req 11647BR Job Posting Title Specialist System Administrator - VDI 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 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. 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. 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 Masters degree & 3 years of directly related experience OR Bachelors degree & 5 years of directly related experience 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. Preferred Qualifications 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 teamUnited StatesAmgen2011-08-12 22:18:34CaliforniaCAThousand Oaks, CA22999180http://www.amgen.jobs/xml/22999180/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 Amgens 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 - Masters degree & 6 years of directly related experience OR - Bachelors degree or & 8 years of directly related experience OR - Associates 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.United StatesAmgen2011-06-25 18:26:38CaliforniaCAThousand Oaks, CA22025629http://www.amgen.jobs/xml/22025629/jobUSAThousand OaksAuto req 8304BR Job Posting Title Sr Engineer Career Category Quality Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description As a member of Amgen's Commercial Quality group for drug delivery, this position will provide engineering support for new product development and ensure design control systems are followed in the creation of new drug delivery devices. Responsibilities include participation in Corrective and Preventive Action projects; responsible for documentation related to investigation of product complaints, trending of quality data, and other assignments as given. With general guidance, employee will work with process development and operations to ensure robust designs are validated, qualified and launched. In addition to new development the responsibilities will include working on cross functional teams to understand product inquiries, reduce complaint rates and provide support for troubleshooting operational issues and capital projects. Experience with quality systems should include: ISO 9001: 2000 (ANSI/ISO/ASQ Q9001-2000), ISO 13485:2003 or related compliance regulations and management of engineering development procedures. Employee will apply advanced engineering principles to the design and implementation of system modifications and/or capital projects. Employee will develop, organize, analyze, present and implement results for operational issues or engineering projects of moderate scope and complexity. Basic Qualifications - Doctorate degree OR - Masters degree & 3 years of directly related experience OR - Bachelors degree & 5 years of directly related experience OR - Associates degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - BA/BS in Science, Engineering, or related field - 7+ years of Quality or Operations experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in validation, investigations and/or change control - Knowledge of Design Controls - Experience with product design enhancements/improvements - Experience in interacting with regulatory agencies - Good written and verbal communication skills - Ability to interpret and apply regulatory and quality requirements - Ability to work independently as well as on teams - Ability to prioritize and manage multiple tasks - Ability to work in a challenging and fast-paced work environmentUnited StatesAmgen2011-04-19 19:43:42CaliforniaCAThousand Oaks, CA20797767http://www.amgen.jobs/xml/20797767/jobUSAThousand OaksAuto req 8941BR Job Posting Title Senior Engineer - Device Engineering Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position reports into the Device Delivery Engineering group in Thousand Oaks. This position will work with advanced and diverse engineering principles to execute the proper design, qualification and implementation of devices utilizing associated systems such as documentation, equipment and processes. The Senior Engineering must also leverage skills with device development, manufacturing and test equipment, injection molding, and material science to advance device development program for high volume consumable devices. In this position you will be expected to be able to execute tolerance analysis, stress analysis, and mold analysis of device components. Scope will include a wide range of products including; needle protection systems, autoinjectors, and reconstitution systems. 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. Responsibilities -Support the technical execution of drug delivery projects. - Sustaining support for commercialized drug delivery projects. -Responsible for engineering aspects of the development and commercialization of drug delivery devices -Work cross-functionally with individuals and project teams in Operations to advance device programs at Amgen. -Work with Amgens partners in the support of device, diagnostics, and ancillary items. . Basic Qualifications Doctorate degree OR Masters degree & 3 years of directly related experience OR Bachelors degree & 5 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications MS in Mechanical Engineering, or other Engineering/Life Sciences 8 years of experience in engineering specific to the device or biotech/pharmaceutical industry. 2 years of experience with automated assembly equipment. Demonstrated Competencies/Skills: -Strong background in engineering and commercialization process with injectable devices, and experience in or knowledge of processes for the production of novel formulation is also desired. -Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. -Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. - 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 -Industrial 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). -Experience or knowledge in the process development of combination product aspects of these systems for macromolecules is desired. -General knowledge of regulatory, marketing, business development and quality aspects of drug delivery device/system development is also desired. -Experience with partnerships between pharmaceutical and drug delivery companies. Independent thinker with demonstrated skills working in teams or leading project teamsUnited StatesAmgen2011-04-05 20:48:36CaliforniaCAThousand Oaks, CA20538626http://www.amgen.jobs/xml/20538626/jobUSAThousand OaksAuto req 13335BR Job Posting Title Supply Chain Mgr - Transportation Career Category Supply Chain Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description As Amgen expand globally, this position is key in implementing projects that support the region strategic plans. Working cross functionally by establishing new supply routes, distribution models, systems set up, ensuring cold chain, and overall transport and distribution coordination. Responsible for the movement of imported/exported raw materials and finished products to the production and distribution points in the Latin America Region Responsible for operations management, metrics reporting, and compliance to standard policies and procedures to support the current commercial operations and emerging markets commercial launch strategy Responsible for identifying, establishing and monitoring key performance measures that will insure the achievement of best practices and operational across the deliver global network focus on commercial product Serve as a key Transportation representative for the region on various cross-functional task forces and teams to insure consistent and well-integrated practices are developed throughout the organization The position will require between 30 and 50% travel domestic and international Basic Qualifications Doctorate degree OR Masters degree and 3 years of directly related experience OR Bachelors degree and 5 years of directly related experience OR Associates degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications MBA 5 or more years of experience in transportation/logistics/supply chain Experience with distribution, transportation, and import/export regulations in the Latin America region Strong knowledge of enterprise resource planning systems and other supply chain system applications Strong communication, teambuilding and negotiating skills are critical to success in this role Biotech/Pharma experience and/or experience in a multi-national companyUnited StatesAmgen2012-01-12 19:06:52CaliforniaCAThousand Oaks, CA25859166http://www.amgen.jobs/xml/25859166/jobUSAThousand OaksAuto req 13426BR Job Posting Title Specialist IS Architect (R&D App Architecture) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgens Research & Development division is the engine for discovering and developing new therapies as well as monitoring patient safety. The Specialist IS Architect for the Research & Development Application Architecture team is responsible for delivering a solution architecture for major R&D programs while contributing to the overall technology strategy and roadmap for R&D. Job Responsibilities: - Partner with business users, Client-facing IS teams, project teams, architects, and technical leads to deliver an effective and maintainable solution architecture. - Use experience to design application and integration solutions that are architected for performance, scalability, and lifecycle efficiency. - Apply and understand Amgen enterprise standard practices and technologies that are relevant to solutions. - Provide project teams with technical direction and expertise in all aspects of solution delivery such as networking, data design, web technologies, application integration and software engineering. - Review and approve the architecture of proposed or in-progress systems. - Work within team to craft strategic technology roadmaps for R&D. - Contribute to growth of Enterprise Architecture team through technology advancement, creation of shared artifacts, and communication of best practices. Basic Qualifications - Doctorate degree OR - Masters degree & 3 years of directly related experience OR - Bachelors degree & 5 years of directly related experience OR - Associates 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 - Background in developing enterprise-class web application and/or integration solutions - 8-10 years of development experience and 2+ years working with mobile applications - Strong working knowledge of application integration patterns and technologies - Demonstrated ability to use UML for architecture modeling activities - Strong problem solving and interpersonal skills; consulting experience desiredUnited StatesAmgen2012-01-12 19:05:39CaliforniaCAThousand Oaks, CA25859131http://www.amgen.jobs/xml/25859131/jobUSAThousand OaksAuto req 11971BR Job Posting Title Sr Mgr Information Systems - OIS Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Sr. Manager in this position will report in the Operations Information Systems (OIS) organization and will be primarily responsible for managing the Thousand Oaks, California-based client facing team which develops and supports the Laboratory Information Management System (SM-LIMS), Laboratory Method Execution Systems and Chromatography Data Systems. These are the primary application platforms used by Amgen Quality Control Laboratories in Operations sites to support sample management and testing of product, environmental monitoring, and raw materials. The position will partner with key stakeholders, both in business and across IS to provide service to corporate and site-based Quality Control Laboratory clients. Manage the ongoing expectations and prioritization of client requirements. Key Responsibilities Team management and Staff development The position will initially have six to seven direct reports who are responsible for the execution of development, deployment and support of SampleManger LIMS software and services. The daily activity coordination and the career development of the each team member is a key responsibility of this position. System Owner for SampleManager LIMS (SM-LIMS) This position will be the system owner for SampleManager LIMS and will be accountable for ensuring that all responsibilities of this role are performed. The position will oversee the lifecycle management of the SM-LIMS application as well as maintenance activities, client communications, related execution of IS and OIS initiatives, disaster recovery and compliance oversight. Release Management SM-LIMS changes are managed through a release management process. This position will be responsible for working with the team and clients to determine and execute release content, timing, construction, validation, and implementation. Client relationship management This position will be responsible for managing key client relationships that are essential for the lifecycle management of SM-LIMS. This position will also participate and provide oversight for the client contacts of the business analysts on the team. New Site Implementation Coordination When new sites are implemented, this position will work with key clients and the team to coordinate and execute the OIS responsibilities associated with the new implementation. Manage budgets for external services This position is responsible for managing the use and budgets of external service providers for level 2 and level 3 support services. The position will work with OIS internal and external IS service groups to provide the contracted services. Lead SampleManager Upgrade Effort This position will be accountable for leading the upgrade of Amgens SM-LIMS implementation. Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Masters degree & 6 years of directly related experience OR - Bachelors degree & 8 years of directly related experience OR - Associates 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 Engineering, Information Systems or Computer Science. Advanced degrees and/or Life Sciences experience preferred. Past experience working in a global environment. Past experience working in a manufacturing or research laboratory. 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 clients to understand their business processes, manage scope of work expectations and suggest / recommend IS solutions. Leadership, project management, communication, analysis, customer service, change management and interpersonal skills (e.g. conflict resolution) and demonstrate ability to function in a matrix team environment. Experience with prototyping approaches to software development. Experience directing 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 developers team, preferably with an industry partner. Ability to master, with minimal support, new IS technologies and processes. Excellent 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 provide leadership through 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 satisfies 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 Amgen IS quality and compliance policies, SOPs and associated documents. Position will require 10-20% travel. 20United StatesAmgen2011-10-18 18:40:17CaliforniaCAThousand Oaks, CA24283529http://www.amgen.jobs/xml/24283529/jobUSAThousand OaksAuto req 9815BR Job Posting Title Health Economics Sr 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 years of directly related experience OR -Masters degree & 6 years of directly related experience OR -Bachelors 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.United StatesAmgen2011-12-01 22:28:45CaliforniaCAThousand Oaks, CA25141667http://www.amgen.jobs/xml/25141667/jobUSAThousand OaksAuto req 8946BR Job Posting Title Principal Engineer - Drug Delivery Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Successful candidate will lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these high volume consumable components. The Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support validation and regulatory submissions of these devices. The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Position Responsibilities Oversight and execution of drug delivery projects in the nephrology/oncology therapeutic areas. Global oversight responsibilities of device related project at Amgen sites. Responsible for engineering aspects of the development and commercialization of drug delivery devices/systems and novel formulations for macromolecules. Work cross-functionally with individuals and project teams in Marketing, Operations, and Development and serve as a primary contact with Amgen's external drug delivery partners. Work with Amgens partners in the support of device, diagnostics, and ancillary items. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree & 8 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications BS in Engineering and previous experience in a medical device industry 10 years current experience with engineering processes and procedures. Led projects from development through the 510k and PMA approval process. Familiarity with lean manufacturing and six-sigma methodology. Strong background in engineering and commercialization of injectable devices. Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. Familiar with the following standards: o US Good Manufacturing Practices 21CFR820 o Quality Management ISO 13485 o Risk Management ISO 14971 o EU Medical Device requirements Council Directive 93/42/EEC o Medical Electrical Equipment EN 60601 Small scale device assembly experience. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Strong problem solving, risk assessment, and risk management skills. Must be capable of working on multiple projects in a deadline driven environment. Must have strong oral and written communication skills, decision making, presentation and organization skills.United StatesAmgen2011-05-23 22:25:01CaliforniaCAThousand Oaks, CA21426197http://www.amgen.jobs/xml/21426197/jobUSAThousand OaksAuto req 13034BR Job Posting Title Tax Senior Manager Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Senior Manager of Tax Planning will be responsible for providing support on tax planning initiatives and implementing the companys tax strategy. This requires substantive knowledge in domestic and international taxation and strong interpersonal and communication skills. The Senior Manager of Tax Planning will have primary responsibilities for providing tax planning advice and guidance on tax planning initiatives and tax structuring, liaisoning with clients in the functional areas and managing and directing planning projects. In addition, the Senior Manager of Tax Planning will also be responsible for providing technical support to the Tax Provision, Tax Compliance, and Tax Audit groups and foreign subsidiaries, assisting with M&A due diligence and integration and assisting with international expansions. The qualified candidate should have a minimum of 7 years of tax planning experience with significant expertise in the international taxation area from a Big Four Accounting firm, a major law firm or a tax department of a multinational corporation. A solid working knowledge of international taxation and strong interpersonal and communications skills are essential. Ability to work in a fast-paced environment and a strong teamwork focus are also essential. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree or & 8 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications A Bachelors Degree in Accounting or Finance with a CPA or a degree in Law A LLM or MBT is preferred At least 7 years of experience in tax planning, along with three or more years in international tax planning, from a Big Four Accounting firm, a major law firm or a tax department of a multinational corporation Solid working knowledge and experience in international taxation and structuring Good understanding of transfer pricing and tax accounting Experience with pharmaceutical, biotech or high tech industry is preferred On a personal level, the Senior Manager of Tax Planning should: Be an experienced tax professional who functions in a fast-paced environment with a minimum of guidance Have strong interpersonal skills and the ability to work in a team-oriented environment Possess excellent written, presentation and communication skills to work with all levels of staff and management Demonstrate leadership capability and team leader/player skills Demonstrate strong organizational, planning and project management skillsUnited StatesAmgen2011-12-06 19:03:01CaliforniaCAThousand Oaks, CA25208939http://www.amgen.jobs/xml/25208939/jobUSAThousand OaksAuto req 13063BR Job Posting Title Undergrad Intern - Finance Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgens Finance departments at our Thousand Oaks headquarters is looking for undergraduate students interested in 10 12 week internships to be an integral part of the team and provide 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. Further responsibilities may include financial modeling, analysis of Finance spending, preparation and presentation of financial materials, variance analysis and special projects. In addition to day-to-day tasks, a final project and presentation will be required at the end of the internship. Associates may support the Global Commercial Operations, Research & Development, Operations, Treasury, or Tax Finance Organizations. 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 degree Must in the process of earning a Major or Minor in Economics, Business, Accounting or Finance Must have a 3.2 GPA Must be a Junior and planning to graduate in December 2012 or Summer 2013 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 Prior work experience a plus Biotechnology, pharmaceutical or healthcare industry experience is a plus but not required 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 tasksUnited StatesAmgen2011-12-06 19:03:49CaliforniaCAThousand Oaks, CA25208954http://www.amgen.jobs/xml/25208954/jobUSAThousand OaksAuto req 13073BR Job Posting Title Global Safety Medical Director 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 Inflammation 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, EUMSUnited StatesAmgen2011-12-23 19:32:33CaliforniaCAThousand Oaks, CA25538814http://www.amgen.jobs/xml/25538814/jobUSAThousand OaksAuto req 12719BR 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 The Portal & Collaboration Sr Associate Business Analyst is primarily responsible for working with internal Amgen clients and client-facing IS groups to assist with the development of portal and collaboration solutions using the SharePoint MOSS 2007 platform. Strong business analysis skills are required in order to work with client organizations, gather their requirements for web/collaboration needs, and develop solutions. Seeking forward looking candidates that look for new and creative ways to utilize technologies and tools to meet client and the programs needs. Responsibilities include client engagement, requirements elicitation, process and systems analysis, identification of automation solutions and approaches for addressing business needs, and supporting the development of business cases for proposed solutions. The successful candidate will establish and maintain a positive business relationship with managers, staff and external business partners that utilize the COEs 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. 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 COEs service offerings. 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 processes and follow accepted Amgen IS policies and standards is mandatory. Basic Qualifications Masters degree OR Bachelors degree & 2 years of directly related experience OR Associates degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience Preferred Qualifications Knowledge of Microsoft SharePoint 2007 (MOSS) Skilled in giving presentations to client groups Past position involving close interaction with client groups, and ability to effectively manage client relationships IT business analysis experience involving helping client groups optimize their business processes Project management using RUP methodology Ability to quickly adapt to changes in client needs and reformulate plans accordingly Skilled at organizing, developing and documenting client requirements Strong organizational and work planning skills are needed Strong web site and page design and layout skills High level of technical competency with Microsoft Office technologies. Development of policies, SOPs and associated documents. Knowledge in areas: o Portals and Document Management Systems o Collaboration Tools o Iterative Development o Formalized Requirements GatheringUnited StatesAmgen2011-12-04 19:40:37CaliforniaCAThousand Oaks, CA25175614http://www.amgen.jobs/xml/25175614/jobUSAThousand OaksAuto req 13220BR 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 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 -Masters degree & 6 years of directly related experience OR -Bachelors degree & 8 years of directly related experience OR -Associates 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 organizationUnited StatesAmgen2012-01-05 02:59:22CaliforniaCAThousand Oaks, CA25703357http://www.amgen.jobs/xml/25703357/jobUSAThousand OaksAuto req 13228BR Job Posting Title Grad Intern Career Category Research Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Program Summary: Amgen's corporate headquarters is located along the southern California coast between Santa Monica and Santa Barbara (40 miles west of Los Angeles). Amgens internship program offers meaningful project experiences that impact patients lives, competitive compensation, housing benefits (for eligible candidates), executive networking events, social networking events, community volunteer project opportunities, on-site fitness center and much more. Job Description: Interns will receive a valuable introduction to the role of observational research (epidemiology) in the development of therapeutics. The Center for Observational Research at Amgen, Thousand Oaks has internship positions available for highly qualified epidemiology or public health sciences PhD students. Interns will work for 10 to 12 weeks with a senior-level epidemiologist or public health scientist on projects related to disease areas in which Amgen is developing new therapeutics, e.g., oncology, nephrology, metabolic diseases, osteoporosis and inflammation. Interns will present a summary of their work in both oral and written formats (department seminar and a manuscript suitable for submission to a biomedical journal). The projects related to this opportunity will provide the intern with a better understanding of: (i) the role of public health scientists in the biopharmaceutical industry, (ii) application of pharmacoepidemiology methods to address questions of interest in drug development and commercialization, and (iii) presentation of research findings. 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 a current student in a public health sciences (e.g., epidemiology) PhD program Completed core doctoral coursework by June, 2012 Must have SAS experience 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 currently enrolled at an accredited four-year college or university as a 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 Proficient in SAS.United StatesAmgen2012-01-05 02:59:26CaliforniaCAThousand Oaks, CA25703360http://www.amgen.jobs/xml/25703360/jobUSAThousand OaksAuto req 13136BR Job Posting Title Sr Mgr Supplier Quality Career Category Quality Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This highly visible position will report to the Director of Supplier Quality Management and serves as a member of the External Quality extended leadership team. Responsible for the oversight of a segment of Amgens GMP raw materials and suppliers to make certain that quality raw materials are provided to Amgen manufacturing for the production of vital medicines to our patients worldwide Specific duties include: Manages improvements to Supplier Quality operational programs, systems, and procedures Establishment and active management of realistic personal and functional goals in alignment with key business objectives Provides leadership in ensuring consistent resolution practices for raw material and supplier related issues in accordance with cGMPs Influences site and corporate stakeholders towards achieving business goals Manage successful and timely accomplishment of assigned goals, objectives, and projects Represents department practices, programs and procedures to our internal customers Actively engages with industry groups regarding raw material, supplier, and supply chain security trends Implements innovative solutions to emerging changes in business or regulatory challenges Works in partnership with executive management to develop business plans that fosters staff development and supports the direction of the business Plans and oversees major change efforts Contributes to the business results through quality of decisions, results and advice related to raw material and supplier management Serves as a role model and mentor for direct staff and raw material stakeholders Basic Qualifications Doctorate degree and 2 years of directly related experience OR Masters degree and 6 years of directly related experience OR Bachelors degree or and 8 years of directly related experience OR Associates 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 10 years of related experience in quality supply management 8 years experience in regulated environment including, GMP 8 years in cross-functional leadership roles Executive management communication experience Public speaking/presentation experience Ability to adapt to changing business needsUnited StatesAmgen2012-01-10 18:11:00CaliforniaCAThousand Oaks, CA25802516http://www.amgen.jobs/xml/25802516/jobUSAThousand OaksAuto req 13529BR Job Posting Title Sr Project Manager - Product Strategy Team Career Category Operations 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 and 2 years of directly related experience OR Masters degree and 6 years of directly related experience OR Bachelors degree and 8 years of directly related experience OR Associates 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 marketed product development - Experience working on medical devices - Experience in oncology drug development - Excellent verbal and written skillsUnited StatesAmgen2012-01-26 22:26:06CaliforniaCAThousand Oaks, CA26140214http://www.amgen.jobs/xml/26140214/jobUSAThousand OaksAuto req 12252BR Job Posting Title Corp Audit IS Senior Manager 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 Audits 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 - Masters degree & 6 years of directly related experience OR - Bachelors degree or & 8 years of directly related experience OR - Associates 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 desirableUnited StatesAmgen2011-09-29 09:13:12CaliforniaCAThousand Oaks, CA23915639http://www.amgen.jobs/xml/23915639/jobUSAThousand OaksAuto req 12987BR 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 mechanical 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 Bachelors degree OR Associates 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 teamsUnited StatesAmgen2011-11-30 18:30:10CaliforniaCAThousand Oaks, CA25108651http://www.amgen.jobs/xml/25108651/jobUSAThousand OaksAuto req 13461BR Job Posting Title Sr Mgr Process Development Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Senior Manager will provide scientific and technical leadership to a technical group responsible for transferring and providing ongoing manufacturing support of biologics based drug product processes to a commercial drug product manufacturing site. The responsibilities include the following - 1. Technical evaluations of technologies for new drug product manufacturing plants, specifically filling technologies, Barrier Isolator, Ebeam, and Visual Inspection. Develop and characterize DP processes and equipment, and identify/ implement Operational Excellence opportunities. Provide recommendations to senior management and assist in making high impact decisions. 2. Development of process and technology transfer details for transfer of drug product processes to manufacturing plants globally. Leading cross site teams to support the above activities. 3. Providing technical evaluation support for ongoing production, qualification, validation activities, NC/CAPA support, process improvements, scale up of drug product processes. 4. Drug product lifecycle management activities, evaluating and implementing new technology related to improvements to the current process, regulatory submissions and international expansion. The candidate will author/review critical regulatory document sections and other technical documents. 5. Provide drug product technical leadership to a group of 7+ engineers and scientists to conduct the above activities. The job is knowledge-based and the candidate should possess the ability to think analytically and the desire to continue to develop technically and professionally. Domestic and International travel is expected to be 25%. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree & 8 years of directly related experience OR Associates 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 Engineering and 12+ years experience in support of Commercial Drug Product (DP) processing in specific areas such as GMP Sterile Processing, Process Characterization, Drug Product Manufacturing Technologies, and Validation. Experience with commercial drug product development, characterization, barrier isolator / ebeam / filling technologies, and/or technology transfer will be a plus. MS in Engineering, Chemical or Electrical Engineering Typically 5 or more years of management experienceUnited StatesAmgen2012-01-17 22:03:11CaliforniaCAThousand Oaks, CA25943993http://www.amgen.jobs/xml/25943993/jobUSAThousand OaksAuto req 13463BR Job Posting Title BAI Senior Manager, Primary Market Research, Rheumatology Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This Business Analysis & Information (BAI) team member is assigned to support the Amgen Inflammation Business Unit. This person will: Create productive relationships with assigned 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, commercial analysis, and forecasting Independently plan, design, and conduct multiple simultaneous complex projects (health care professional and consumer) in support of the brand plan, proactively defining the critical path, anticipating potential obstacles, and recommending actions to keep projects on track Actively collaborate with co-promote partners on shared projects 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 an 18-24 month commitment to this role. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree & 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 Inflammation therapeutic area, with established networks (suppliers, thought leaders, practitioners, etc.), understanding of the evolving market dynamics, and familiarity with key competitors (activities, strategic intent, views, assumptions) Experience with Consumer/DTC marketing in biopharma 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 environmentUnited StatesAmgen2012-01-17 22:03:09CaliforniaCAThousand Oaks, CA25943992http://www.amgen.jobs/xml/25943992/jobUSAThousand OaksAuto req 13095BR Job Posting Title Instructional Design - Healthcare Compliance and Training, Compliance Senior Manager Career Category Training Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description As a senior member in Policies, Training and Communication, this individual will lead the design, development and implementation of training activities related to new or revised Healthcare Compliance Standard Operating Procedures (SOPs) for the Commercial, R&D, and other relevant internal audiences. This individual is responsible for designing and delivering high quality programs with significant complexity and impact on staff throughout the Amgen organization. The Sr. Training Manager is focused on being a strategic business partner to a variety of clients to ensure the most appropriate training solutions are utilized; this includes the use of blended learning solutions (e.g., ILT, one-on-one and e-learning). This person will be responsible for managing assigned projects, from needs assessment through delivery, to ensure that training and development programs are implemented to support business needs. Responsibilities include: Utilizes instructional design methodologies to design and develop solutions for healthcare compliance training programs in a variety of delivery formats Works in partnership with key internal training professionals to leverage enterprise services Understands the evolving healthcare compliance landscape, applicable laws, regulations, guidelines and Amgen policies and procedures Develops and manages project schedules to ensure the project timelines/deadlines are met Writes instructional materials, quick reference guides, job aids, etc. as well as performing modifications to existing course material Coordinates project team meetings and works in cross-functional teams to ensure flawless execution of programs Manages and works with outside vendors/contractors Basic Qualifications Doctorate degree & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree or & 8 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Masters Degree in Instructional Technologies or Instructional Design preferred Minimum 5 years experience managing large-scale training projects Experience in Health Care or related industry preferred Experience building training for iPad and plus Knowledge of the healthcare industry, recent federal and state enforcement activities, and the laws and regulations relating to the development, approval, and commercialization of biotechnology/pharmaceutical products is a plus. Proven project management and problem solving ability. Effective communication and writing skills. Ability to work with staff across all levels of the organization. Strong competency in the area of instructional design, adult learning theory, online courseware design, web interface design, SCORM and basic web and user interface usability standards required. Ideally have experience designing highly interactive eLearning Proficiency with PowerPoint, Articulate, Captivate, Flash Experience with graphic design tools (Photoshop, Illustrator) Strong project management skillsUnited StatesAmgen2012-01-06 18:37:17CaliforniaCAThousand Oaks, CA25735925http://www.amgen.jobs/xml/25735925/jobUSAThousand OaksAuto req 13439BR Job Posting Title Strategy Mgr - International Commercial Operations Career Category College Job Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen's Global Commercial Operations (GCO) function includes North America Commercial Operations and International Commercial Operations. North America Commercial Operations (NACO) is comprised of marketing, sales, and operations teams in the United States and Canada dedicated to driving commercial efforts that support Amgen's goals and aspiration to be the best human therapeutics organization. International Commercial Operations (ICO) markets and sells Amgen's products in countries outside of North America and Canada. It is organized by region (Europe & Australia, Emerging Europe, Middle East & Africa, Latin America, and Asia/Japan), by Franchise (oncology, nephrology and bone & new products), and by function. Amgens International Headquarters is in Zug, Switzerland. This position will be part of International Commercial Operations and will report directly to an ICO leader in Thousand Oaks or abroad. The successful candidate will have a chance to: Apply structured problem solving approaches to key international business situations, working cross functionally to integrate results from other departments & disciplines Create productive relationships across the Global Commercial organization including Global Marketing, North America Commercial Operations, Global Value & Access, etc Partner with international Headquarters (Zug, Switzerland), Regional Offices, and affiliates to optimize ICO performance (MIP goals, strategic projects, etc) Coordinate with Zug and Regions on commercial initiatives including marketing, sales, and business development Lead the plan, design, and conduct of 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 Analyze sales performance, market research, and market environment; develop recommendations to ICO leadership Identify business opportunities and develops business cases Manage external vendors as needed Translate/implement international campaigns locally in English as a primarily language of communication but also in one or more of the foreign languages such us Russian, Chinese, Japanese, Portuguese, Spanish, etc. This position will include some international travelling, estimated for 25%. Basic Qualifications Prospective candidates must be in the process of completing their final year of their Master of Business Administration (MBA) Degree. Minimum of 3 years work experience. Preferred Qualifications Minimum 2 years in a pharmaceutical or healthcare company Track record of demonstrated leadership Excellent oral, written and presentation skills Strong project management skills. Strong organizational, project management, detail oriented, analytical and quantitative skills Demonstrated personal initiative, self-motivation, flexibility and adaptability Ability to effectively operate independently, across functional lines, and with both internal and external customers Ability to work successfully in a team and matrix environment Previous sales and marketing experience English as primarily and at least one additional language (preferably Russian, Chinese, Japanese, Portuguese, or Spanish)United StatesAmgen2012-01-13 19:06:51CaliforniaCAThousand Oaks, CA25885821http://www.amgen.jobs/xml/25885821/jobUSAThousand OaksAuto req 13455BR Job Posting Title Grad Intern - International Commercial Operations Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen's Global Commercial Operations (GCO) function includes North America Commercial Operations and International Commercial Operations. North America Commercial Operations (NACO) is comprised of marketing, sales, and operations teams in the United States and Canada dedicated to driving commercial efforts that support Amgen's goals and aspiration to be the best human therapeutics organization. International Commercial Operations (ICO) markets and sells Amgen's products in countries outside of North America and Canada. It is organized by region (Europe & Australia, Emerging Europe, Middle East & Africa, Latin America, and Asia/Japan), by Franchise (oncology, nephrology and bone & new products), and by function. Amgens International Headquarters is in Zug, Switzerland. Amgen ICO Organization is seeking a highly talented individual to join the team as a summer graduate intern. The intern will be working with ICO leadership from Amgens HQ in Thousand Oaks, CA, focused on an assignment addressing a current business needs in commercial initiatives including marketing, sales, and business development and offering the opportunity to apply their business skills and experience. Grad Intern will be involved in variety of projects in support of global strategic plans and will be interacting with ICO team in order to analyze development opportunities and develop recommendations to the ICO Leadership. 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 Only candidates who apply via www.amgen.com/careers will be considered. Please search the database via career category College Job, requisition#13455BR. Basic Qualifications Prospective candidates must be in the process of completing their first year of their Master of Business Administration (MBA) Degree. Minimum of 3 years work experience. 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 1. Speak fluent English plus an additional language 2. Demonstrated leadership skills 3. Excellent oral and written communication skills, presentation skills and interpersonal skills 4. Strong organizational, project management, detail oriented, analytical and quantitative skills 5. Demonstrated personal initiative, self-motivation, flexibility and adaptability 6. Ability to effectively operate independently, across functional lines, and with both internal and external customers 7. Ability to work successfully in a team and matrix environment 8. At least 6 months US based experience preferred 9. Biotechnology, pharmaceutical or health care industry experience 10. Previous sales and marketing experience 11. Ability to travel internationally, up to 25% of timeUnited StatesAmgen2012-01-13 19:06:51CaliforniaCAThousand Oaks, CA25885822http://www.amgen.jobs/xml/25885822/jobUSAThousand OaksAuto req 13349BR Job Posting Title Clinical Research Medical Director - General Medicine and Inflammation Therapeutic Area 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 (General Medicine and Inflammation Therapeutic Area) 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 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) 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 issuesUnited StatesAmgen2012-01-06 18:37:29CaliforniaCAThousand Oaks, CA25735939http://www.amgen.jobs/xml/25735939/jobUSAThousand OaksAuto req 13175BR Job Posting Title Medical Writing Senior Manager - Cardio / Renal Career Category Medical Affairs Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Medical Writing Senior Manager is a full-time, corporate office-based position in Thousand Oaks, CA. In this position, the successful candidate will be responsible for developing publications for a cardio/renal pipeline molecule. The Senior Manager will work closely with external authors and key internal stakeholders to develop high-quality manuscripts and review articles for peer-reviewed journals as well as abstracts, posters, and slide presentations for scientific congresses. The Senior Manager will provide strategic input to product publication teams and scientific congress planning teams; will liaise with medical leads, biostatisticians, safety experts, and health economists as well as external opinion leaders, investigators, authors and journal editors; and may prepare/edit briefing documents for submission to external, regulatory bodies or other documents for internal, informational purposes. The Sr. Manager may also contribute to internal, process improvement task forces. Additional responsibilities may be assigned and may include training new writers and/or managing new writers as direct reports; overseeing the work of freelancers, vendors, and junior writing colleagues; and providing writing support for other scientific response documents as needed. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree & 8 years of directly related experience Preferred Qualifications Doctorate degree At least 3 years of medical writing experience in a biotech or pharmaceutical company, preferably in the oncology therapeutic area Experience analyzing and communicating scientific data in peer-reviewed journal publications and in abstracts and presentations at scientific congresses Superb written and verbal communication skills Knowledge of publication guidelines and best practices Proficient in pertinent software (eg, MS Office, EndNote, Adobe Illustrator) Experience leading and delegating projects, with limited supervision Experience advancing numerous projects simultaneously Experience working in a matrix team environment Experience with budget and vendor management Experience with training or managing staffUnited StatesAmgen2011-12-19 21:16:50CaliforniaCAThousand Oaks, CA25455091http://www.amgen.jobs/xml/25455091/jobUSAThousand OaksAuto req 11902BR Job Posting Title Principal IS Architect - Performance Engineering Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Principal IS Architect - Performance Engineering will guide project teams to deliver applications to meet their performance targets and provide performance analysis and troubleshooting supports to resolve performance problems and improve system performance. This position requires both architecture knowledge to design high-performing systems and hands-on skills to troubleshoot complex systems. In addition, this position needs to provide leadership to the performance engineering practice and establish relevant process, tools and engagement plans for the enterprise-wide service. Job Responsibilities Provide architecture consultation and guidance to project teams to establish performance targets and design systems that will meet the performance targets Provide consultation and hands-on support to project teams and systems stakeholders to identify performance issues and provide improvement suggestions Provide architecture, design and deployment reviews to ensure that proposed environment changes will not cause unexpected performance impacts Establish the relevant tools, process and procedure for the Performance Engineering service Conduct experience sharing sessions to promote the awareness of performances issues; offer opportunities for other technical professionals to gain the knowledge and skills in performance engineering Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Masters degree & 6 years of directly related experience OR - Bachelors degree & 8 years of directly related experience OR - Associates degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - MS in Computer Science or a relevant discipline - 5 years experience architecting enterprise-scale applications and systems - 10 years hands-on experience on performance instrumentation, investigation, troubleshooting, analysis and improvement - Proficiency in troubleshooting various application components, including web application, Java, Java Scripts, application servers, database and middleware - Proficiency in troubleshooting many layers of the infrastructure technology stack, including network technologies, security technologies, identity and access management technologies, operating systems, VMware, database management systems and storage systems; experience of troubleshooting in the cloud environment a plus - Proficiency in utilizing a wide range of performance tools, including network sniffers, tcpdump, application trace/debug/profile, file monitors and database monitors to collect system information and conduct analysis - Ability to troubleshoot issues on Windows and Unix-based platforms - Ability to establish an automated process for performance monitoring and improvement - Experience in architecture governance and change management process - Highly effective problem solver, with strong desire to learn new technologies and mentor junior staffUnited StatesAmgen2011-08-24 20:14:39CaliforniaCAThousand Oaks, CA23225743http://www.amgen.jobs/xml/23225743/jobUSAThousand OaksAuto req 11920BR Job Posting Title Grad Co-op - Operations Career Category College Job Employee Subgroup Co-Op FT Salaried Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Operations, is the part of Amgen that makes the drugs we deliver to our patients. Made up of five functions and spread across nine sites, Operations aspiration is simple: Ensure patients have access to the Amgen products they need. There are various internship opportunities available within the Operations functions, in particular within Manufacturing, Global Clinical Operations, Engineering, Process Development and Quality. Departments that regularly sponsor intern projects include: Operations Strategy, Supply Chain, and Contract Manufacturing. Operations Co-ops will develop/design and participate in the execution of programs and initiatives to support the strategy of Operations, which includes developing, executing, and potentially managing work plans, identifying data needs, gathering data (quantitative and qualitative), analyzing data, developing recommendations and creating presentations around recommendations. The prospective Co-op will be responsible for supporting their supervisor in issue identification and resolution and for ensuring that all initiative stakeholders are communicated to on a regular basis. The Co-op will be required to participate in various cross-functional projects within Operations (for example, benchmarking, process improvement, etc.) as requested; build cross-functional relationships across Operations as well as with Sales & Marketing, Research & Development and Corporate Functions. Co-op will also need to participate in various Amgen summer internship program activities (e.g., presentations, networking events, etc.). 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 Prospective candidates must be in the process of completing their first year of Dual-degree: MBA & Masters in Engineering. Candidates must have obtained a Bachelors Degree in Engineering, Life Science, Earth Science or Business. 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 at an accredited college or university 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 Pursuing MBA with emphasis in Business, Management, Operations, or Engineering. Previous project management experience. Knowledge and understanding of Good Manufacturing Practices (GMP) and regulatory policies. Strong analytical/quantitative skills; ability to conduct research; self-starter with interpersonal skills; team player; strong communication skills; ability to take on several projects at one time.United StatesAmgen2012-02-02 01:04:30CaliforniaCAThousand Oaks, CA26261161http://www.amgen.jobs/xml/26261161/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 Masters degree & 3 years of experience directly related to the job OR Bachelors degree & 5 years of experience directly related to the job OR Associates 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 Bachelors 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.United StatesAmgen2011-11-01 22:17:20CaliforniaCAThousand Oaks, CA24526977http://www.amgen.jobs/xml/24526977/jobUSAThousand OaksAuto req 13751BR Job Posting Title Specialist IS Bus Sys Analyst (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 the Service Management team within the Information Services Service Management & Governance function, and will be responsible for providing administration, application and development maintenance support for the Integrated Service Management tool (ISM) This position will be an Administrator for Service-Now Application and will work as a member of the support team to configure and maintain the ITIL process in the 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 - Implement new requirements - Maintain validation and training documentation This position will be required to 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 - Masters degree & 3 years of directly related experience OR - Bachelors degree & 5 years of directly related experience OR - Associates degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications Proven skills in Windows Administration and Java Scripting. Prefer candidates with ITIL tool experience. Requires a candidate with experience in all aspects of SDLC from requirements, design, testing, and support. Experience in these areas is a plus: - 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 - The ability to take complex end-user requirements to system requirements to code - Regulatory processes and controls experience, excellent documentation - Able to organize and schedule tasks, develop realistic action plans incorporating time constraints and task priorities. - Demonstrates ability to successfully negotiate with clients - Strong analytical, leadership, and project management skills as well as strong personal commitment to quality service - The ability to work independently and with a team Strong presentation skills, interpersonal skills, verbal and written communications skills. The position will require skills that include: - Excellent communication - The ability to take complex end-user requirements to code - A strong personal commitment to quality service - 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 - Web Technologies or web-based scripting technology (JAVA Script, XML, HTML, AJAX, CSS, HTTP, etc.) - Web applications, networks, protocols and email (SMTP, POP3) - Basic understanding of ITIL v3 methodologies - Understanding of enterprise IT architecture - Working knowledge of relational databases - Strong business analysis, data analysis, and problem analysis skillsUnited StatesAmgen2012-02-02 01:06:29CaliforniaCAThousand Oaks, CA26261227http://www.amgen.jobs/xml/26261227/jobUSAThousand OaksAuto req 13768BR Job Posting Title Project Mgr - Quality Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description As part of the Quality organization, this position, under minimal direction, will be responsible for managing all aspects of key initiatives and projects across multiple business functions in support of our Operational Excellence program. Responsibilities include: Interact with multiple levels of the organization Translate identified improvement opportunities into actionable objectives to effectively drive a project team and make value-based decisions. Scoping/chartering, project strategy, process mapping/definition, process improvement/re-engineering and change management activities. Lead and execute high-priority process improvement initiatives and projects Provide change management assistance to projects facing organizational or major process challenges Deliver high quality and timely results via the use of appropriate methodologies and tools and other key domain expertise Serve as primary project interface to customers and project champions/sponsors Manage and prioritize the Quality project portfolio in conjunction with Quality Executive Leadership Basic Qualifications Doctorate degree OR Masters degree and 3 years of directly related experience OR Bachelors degree and 5 years of directly related experience OR Associates degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications Advanced degree in engineering, life/physical sciences or other technical degree 5 or more years in Continuous Improvement, Industrial Engineering, Lean Manufacturing, Six Sigma or related functional experience within Quality, Manufacturing or Process Development Expert on key Lean Manufacturing tools and approaches (i.e. Value Stream Mapping, Waste Identification, Kaizen, changeover reduction, etc.), while having some familiarity with Six Sigma tools and processes (ie. DMAIC) Certified or experience in process improvement methodologies such as Six Sigma/DMAIC or PDCA Healthcare, pharmaceutical or biotechnology experience Strong leadership skills Demonstrated ability to forge and maintain strong relationships with multiple functional areas 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 ProjectUnited StatesAmgen2012-02-02 01:04:41CaliforniaCAThousand Oaks, CA26261177http://www.amgen.jobs/xml/26261177/jobUSAThousand OaksAuto req 13769BR Job Posting Title Sr Project Mgr - Quality Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description As part of the Quality organization, this position, under minimal direction, will be responsible for managing all aspects of key initiatives and projects across multiple business functions in support of our Operational Excellence program. Responsibilities include: Scoping/chartering, project strategy, process mapping/definition, process improvement/re-engineering and change management activities Interacts with multiple levels of the organization Translate strategy into challenging, actionable objectives to effectively drive the team, advocate client positions throughout the life cycle of the project, and make value-based decisions Lead and execute high-priority process improvement initiatives and projects Provide change management assistance to projects facing organizational or major process challenges Deliver high quality and timely results via the use of appropriate methodologies and tools and other key domain expertise Provide mentorship to less experienced Continuous Improvement practitioners and educate key functional area leadership Serve as primary project interface to customers, project champions/sponsors and steering committees Basic Qualifications Doctorate degree and 2 years of directly related experience OR Masters degree and 6 years of directly related experience OR Bachelors degree and 8 years of directly related experience OR Associates degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications Advanced degree in engineering, life/physical sciences or business 7 or more years in Continuous Improvement, Industrial Engineering, Lean Manufacturing, Six Sigma or related functional experience within Quality, Manufacturing or Process Development Expert on key Lean Manufacturing tools and approaches (i.e. Value Stream Mapping, Waste Identification, Kaizen, changeover reduction, etc.), while having some familiarity with Six Sigma tools and processes (ie. DMAIC) Certified or experience in process improvement methodologies such as Six Sigma/DMAIC or PDCA Healthcare, pharmaceutical or biotechnology experience 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 ProjectUnited StatesAmgen2012-02-02 01:06:14CaliforniaCAThousand Oaks, CA26261219http://www.amgen.jobs/xml/26261219/jobUSAThousand OaksAuto req 13793BR Job Posting Title Strategic Resource Planning Dir Operations Strategic Planning- Career Category Supply Chain Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Our Operations Strategic Planning (OSP) team is an internal management consulting arm of Amgen-Operations focused on optimizing Amgens global operations and supply chain. OSPs clients are typically members of Amgens executive management team, Functional VPs, and Site leadership. OSPs scope of work includes: Optimization of commercial manufacturing/distribution network to balance operational efficiency, costs and risks Prioritization of capital investments to support product pipeline, product lifecycle management and international expansion Development of flexible supply chain strategy in support of globalization and risk management Evaluation of product-launch and pipeline activities to enable commercialization Creation of strategic Operations initiatives to advance Amgens global footprint, market competitiveness and financial performance Support Amgens merger and acquisitions Develop emerging market (Big 7) Operations strategy Job Responsibilities: Manage cross-functional initiatives that advance Amgens international expansion objectives Support Operations due-diligence of potential M&A targets Develop short-term and long-term operational plans for new acquisitions in partnership with key stakeholders in Supply Chain, Finance, Commercial, Process Development, and Regulatory affairs Interface with Regional Operations Leads (ROLs) to support development of regional product launch strategies and associated capital investments Identify areas of improvement in International Operations to improve efficiency, reduce risk, and improve financial performance Conduct project scoping and chartering, define execution strategy and change management Serve as primary interface with executive sponsors Recruit, train, and develop staff Basic Qualifications Doctorate degree and 4 years of directly related experience OR Masters degree and 8 years of directly related years OR Bachelors degree and 10 years of directly related experience Preferred Qualifications Masters degree in engineering, business management or life science and 8 years of related experience 10 years of related experience in life science industry Strong quantitative and qualitative skills including financial analysis, budgeting and multi-site/multi-product Supply Chain planning Demonstrated understanding of drug development, manufacturing and pharmaceutical supply chain Ability to communicate and collaborate across various parts of the organization (Finance, Tax, R&D, Manufacturing, Logistics, Process Development, and Engineering) Good business acumen, high-level strategic thinking and strong analytical skills Demonstrated ability to bring structure to complex problems, pragmatic scoping & problem solving approach, ability to objectively evaluate options/trade-offs and develop Executive management-level recommendations Strong presentation skills Strong interpersonal and influencing skills with a demonstrated ability to drive decisions Proven experience as a member and leader of a high performing team Proven leadership skills and organizational management experience Experience developing and mentoring staffUnited StatesAmgen2012-02-02 18:47:20CaliforniaCAThousand Oaks, CA26275694http://www.amgen.jobs/xml/26275694/jobUSAThousand OaksAuto req 10843BR 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 focused on Research and Development but will also support other functional areas as well. The Senior 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 Senior 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 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 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 teamUnited StatesAmgen2011-06-07 21:26:09CaliforniaCAThousand Oaks, CA21687139http://www.amgen.jobs/xml/21687139/jobUSAThousand OaksAuto req 12277BR Job Posting Title Dir Quality Control Career Category Quality Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Responsible for leading the operations of the Process & Chemical Analysis laboratories (Raw Materials, HPLC/CE, and Bioassay/Immunoassay/Gels) within Clinical QC. Assures that all laboratory areas comply with the established company policies, procedures, analytical methods and current Good Manufacturing Practices (cGMP). Manages resources and personnel to ensure product quality standards are met within the budgeted cost and in compliance with regulatory requirements. Key responsibilities include: • Accomplishes results through personnel supervision assuring on time and high quality results and reports. • Perform timely policy, process related and operational decisions that are within the limits of the company policies, procedures, as well as the regulatory agencies standards and regulations. • Oversee the implementation of quality plans and schedules. • Ensure the efficient use of resources. • May participate in establishing and aligning best practices across sites. • Lead efforts to ensure quality practices are consistent across the facilities and with other site quality operations. • Communicate and implement corporate initiatives and programs. • Recruit, develop, retrain and motivate outstanding staff. Assures compliance with cGMP training requirements for QC staff. • Support validation and production assignments according to schedule without compromising quality. Maintain high professional and compliance standards during production without sacrificing schedule. • Ensure that laboratory equipment and instrumentation is specified, procured, operates and maintained. • Develops and maintains appropriate protocols and procedures as needed. • Interact with regulatory agencies as needed. • Troubleshoots and provides support for manufacturing and process development groups. • Review QC documents, coordinates method development and qualification in analytical chemistry lab. • Coordination of Incident and formal investigations. • Perform management responsibilities associated to development, coaching, mentorship of QC staff, as well as the performance evaluation of direct reports. 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 or PhD in life sciences or engineering •12+ years experience in GMP laboratory setting •6+ years management experience, ideally managing 20+ staff •Previous Lean, Six Sigma, and/or Operational Excellence experienceUnited StatesAmgen2012-02-03 18:30:41CaliforniaCAThousand Oaks, CA26297184http://www.amgen.jobs/xml/26297184/jobUSAThousand OaksAuto req 13765BR Job Posting Title Sr Scientist Career Category Process Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Senior Scientist will provide scientific and technical expertise to a cross-functional Drug Product Team (DPT) in Commercial Drug Product Engineering group including lifecycle management activities, evaluating and implementing new technology related to improvements to the current process, regulatory submissions, international expansion activities, and technology transfers to other manufacturing sites. The responsibilities include the following: 1. Scientific and technical evaluations to support commercial biologics based drug product processes such as formulation, fill, Lyophilization, and visual inspection. Provide technical evaluation for ongoing production, qualification, validation activities, NC/CAPA support, process improvements, and scale up of the drug product processes. 2. Develop and characterize a new lyophilized SKU for the commercial drug product. Develop process and technology transfer details for transfer of drug product processes to manufacturing plants globally. 3. Drug product lifecycle management activities, evaluating and implementing new technology related to improvements to the current process, regulatory submissions and international expansion. The candidate will author/review critical regulatory document sections and other technical documents. 4. Develop and characterize DP processes and equipment, and identify/ implement Operational Excellence opportunities. Provide recommendations to senior management and assist in making high impact technical decisions. 5. Domestic and International travel is expected to be 25%. 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 • 4+ years experience in support of Commercial Drug Product (DP) processing in specific areas such as commercial drug product process development, lyophilization, and / or technology transfer, GMP Sterile Processing, Process Characterization, Fill Finish Equipment and Technologies, and Validation.United StatesAmgen2012-02-03 18:30:57CaliforniaCAThousand Oaks, CA26297207http://www.amgen.jobs/xml/26297207/jobUSAThousand OaksAuto req 13695BR Job Posting Title Health Economics Sr Manager, Bone 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 years of directly related experience OR -Masters degree & 6 years of directly related experience OR -Bachelors 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.United StatesAmgen2012-01-27 20:49:31CaliforniaCAThousand Oaks, CA26163818http://www.amgen.jobs/xml/26163818/jobUSAThousand OaksAuto req 13556BR Job Posting Title Engineer Career Category Operations Employee Subgroup Hourly 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 systems and process 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 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 or support technical root cause analysis, incident investigations, and troubleshooting on equipment (mechanical, electrical, instrumentation and control system problems). Previous training and 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 execution of capital projects. This role involves the application of process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of moderate scope and complexity. Candidate should have previous exposure to project 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 standard engineering principles and practices to work assignments; and ability to employ basics 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 Masters degree OR Bachelors degree & 2 years of directly related experience OR Associates degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience Preferred Qualifications Bachelors degree in Chemical Engineering or Bioengineering preferred 3+ years of relevant work experience with 1+ years experience in operations/manufacturing environment Direct experience in equipment engineering and troubleshooting with fermentors, bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems. Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.) is critical. 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 supporting design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation is preferred. 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.United StatesAmgen2012-01-27 20:49:49CaliforniaCAThousand Oaks, CA26163840http://www.amgen.jobs/xml/26163840/jobUSAThousand OaksAuto req 13659BR Job Posting Title Regulatory Affairs Mgr (CMC Product Team) 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 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: The RA CMC Product team is responsible for execution and/ or coordination of all global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of regulatory strategy. The RA CMC Product Lead is member of the product team , the Global Operations Team, Global Regulatory Team and is responsible for communicating to regulatory strategy, risks and issues to Regulatory and Operations senior management. The CMC Product Lead coordinates communication, collaboration, and coordination with the site and regional CMC representatives on the CMC GRT to develop and execute global regulatory activities. Key Activities: - Contributes to one or more product teams - May act as product lead for one or more products - Provides strategic regulatory input and regulatory risk assessments for product teams - Executes regulatory strategy with respect to preparation of submissions - Complies with critical RA CMC processes - Identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance - Reports needs for process changes to CMC systems and contributes to process improvements - Incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams - Reports issues to RA CMC product team management Knowledge and Skills - Microsoft Suite: Word, Excel, PowerPoint, Outlook - CMC- specific regulatory knowledge & experience Basic Qualifications - Doctorate degree OR - Masters degree and 3 years of directly related experience OR - Bachelors degree and 5 years of directly related experience OR - Associates degree and 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - Degree in Life Science discipline - Experience in manufacture, testing (QC/QA or clinical), or distribution in Biotech/Pharma industry - Regulatory CMC experienceUnited StatesAmgen2012-01-28 21:23:21CaliforniaCAThousand Oaks, CA26176094http://www.amgen.jobs/xml/26176094/jobUSAThousand OaksAuto req 13665BR Job Posting Title Grad Intern - Global Regulatory Affairs & Safety Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgens Global Regulatory Affairs & Safety Strategy and External Operations department at our Thousand Oaks headquarters is looking for a graduate student interested in a 10 12 week internship to run financial model for strategic sourcing initiative and validate output. The intern will be responsible for the following: 1. Update the financial model to reflect any changes and present output with summarized changes / updates. 2. Make recommendations on how to optimize operational model to increase financial value of the project. 3. Develop a supplier market research plan to identify potential project issues and risks 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 Bachelors Degree required. Prospective Candidates must be in the process of completing their first year of their Master of Business Administration degree (MBA) with emphasis in Finance / Valuation / Quantitative Analysis. 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 at the time the internship begins; 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 Experience performing financial valuation of deals Life Sciences / Biopharmaceutical experienceUnited StatesAmgen2012-02-01 02:26:04CaliforniaCAThousand Oaks, CA26231368http://www.amgen.jobs/xml/26231368/jobUSAThousand OaksAuto req 13668BR Job Posting Title Undergrad Intern - Inflammation Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgens Inflammation department at our Thousand Oaks headquarters is looking for an undergraduate student interested in a 10 12 week internship responsible for the following: 1. Culture and maintain primary human keratinocytes and/or epithelial cells 2. Measure the expression of various innate immune receptors in these human cells; 3. Evaluate the impact of innate immune receptor ligands on cytokine production and receptor expression levels; 4. Develop a functional cell assay by identifying the appropriate ligand, ligand concentration, incubation time, and readout; 5. Benchmark tool compounds in the cell assay. 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 obtaining a Bachelors degree in Biology Completion of a science lab course is required 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 at the time of application; 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 Prior experience working in a lab; Experience with basic molecular techniques; Tissue culture experience.United StatesAmgen2012-02-01 02:26:25CaliforniaCAThousand Oaks, CA26231374http://www.amgen.jobs/xml/26231374/jobUSAThousand OaksAuto req 13663BR Job Posting Title Undergrad Intern - Oncology Research Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgens Oncology Research department at our Thousand Oaks headquarters is looking for an undergraduate student interested in a 10 12 week internship to work with a multidisciplinary team focused on developing therapeutics for the treatment of cancer. The project will involve development and application of cell-based assays to evaluate the activity of protein and small molecule therapeutic candidates. Assay techniques will include flow cytometry, microscopy and Western analysis. The intern will also learn skills for characterizing proteins and small molecules. Our group has extensive experience in these techniques and will provide a rigorous and thorough training environment for the intern. Experimental results will be reported to the team in informal weekly meetings providing the intern with the opportunity to develop and practice presentation skills. 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 obtaining a Bachelors degree in a biology-related field. 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 at the time of application; 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 Good communication skillsUnited StatesAmgen2012-02-01 02:26:33CaliforniaCAThousand Oaks, CA26231376http://www.amgen.jobs/xml/26231376/jobUSAThousand OaksAuto req 9441BR Job Posting Title Dir Process Development - 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 Director, Process Development (Cell Sciences & Technology), will lead a team of approximately 40 scientific staff in the development and application of production technologies used to make Amgens clinical and commercial protein therapeutics. This role will be responsible for upstream process development activities including cell line development, clone selection, and fermentation and cell culture development for all protein therapeutics being developed at Amgen Thousand Oaks site. This role will serve as a member of the Process & Product Development Extended Leadership Team that develops and oversees strategies used by the Process and Product Development organization for large molecule development at Amgen. The Director will oversee a number of early and late stage projects, manage a diverse and dynamic workforce of scientists and collaborate with partner functions in Research and Operations to develop Amgens large molecule portfolio. This position will report to the Executive Director, Process & Product Development and will be based in Thousand Oaks, California. Basic Qualifications - Doctorate degree & 4 years of Process Development experience OR - Masters degree & 8 years of Process Development experience OR - Bachelors degree & 10 years of Process Development experience AND - 7 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in a matrix environment Preferred Qualifications PhD in biological sciences, biochemistry, chemical engineering or related scientific area - 10+ years experience in large molecule (protein) process, analytical or formulation development in the pharmaceutical or biotechnology industry - Deep understanding of the regulatory and compliance requirements of protein therapeutics - Demonstrated experience managing a large and diverse team of scientists - Experience developing multiple drug candidates from research through registration - Strong communication, collaboration and team building skills; ability to connect with all levels of the organization - Comfortable working in a matrix environment, while embracing and driving changeUnited StatesAmgen2011-04-01 23:13:58CaliforniaCAThousand Oaks, CA20488414http://www.amgen.jobs/xml/20488414/jobUSAThousand OaksAuto req 12982BR Job Posting Title Risk Management Sr Mgr - Business Continuity Career Category Supply Chain Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen recognizes that in a rapidly-evolving industry landscape, effective supply chain management has become more essential than ever in order to remain competitive and achieve long-term growth. Risk Management is the function within Operations responsible for developing the risk strategy, risk analytical capabilities and brand protection programs. As an integral member of Operational Risk Management (ORM), this position will be responsible for: Subset of strategic initiatives including Business Continuity Planning, strategy development and risk mitigation management Provide leadership and subject matter expertise for the successful sustainment of the Operations Business Continuity and Crisis Management (BCCM) program, an integral part of risk management As the program leader, facilitate a network of BCCM leads across Operations to set contingency planning requirements including continual enhancements to and implementation of global standards, and monitoring the network for their adherence Identify and implement useful tools which can assist the network in meeting BCCM requirements Seek opportunities to reduce program complexity and enhance BCCM planning effectiveness by leveraging internal and external best practices Partner with Operations sites and functions to roll-out operational excellence initiatives, by prioritizing areas for improvement, rigorously assessing contingency plans for development ideas, making enhancements, and coordinating/facilitating emergency exercises Serve as a key risk management leader for Operations and Supply Chain BCCM single point of contact for the Operations and Supply Chain business units including direct ownership of the BCCM plans for these two business units, ensuring they are updated, effective, and tested Partner with other functions within Amgen to align policies, standards, practices and procedures Network across the Biopharma industry though participation in trade groups and consortium to assess practices for consideration within Amgen Function as the BCCM single point of contact for Operations and business units including direct ownership of the BCCM plans for Supply Chain Basic Qualifications Doctorate degree and 2 years of directly related experience OR Masters degree and 6 years of directly related experience OR Bachelors degree and 8 years of directly related experience OR Associates degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications Masters Degree in Science or Engineering 4 or more years of combined experience in operations or other technical discipline Some understanding and practice of risk-based tools, and exposure to business continuity plan concepts 1 or more years of experience in applying Risk Based tools such as: Failure Modes and Effects Analysis (FMEA) 2 or more years of experience owning, developing, or managing business continuity plans Successful operating in a matrix or team environment with site, divisional, and corporate executive leadership Proven ability to lead a cross functional team A demonstrated track record of systems integration is required Excellent oral and written communication skills, excellent interpersonal skills, analytical skills, ability to use work process, briefing and spreadsheet software and ability to use statistical analysis softwareUnited StatesAmgen2012-02-01 02:26:52CaliforniaCAThousand Oaks, CA26231382http://www.amgen.jobs/xml/26231382/jobUSAThousand OaksAuto req 13664BR Job Posting Title Grad Intern - Global Regulatory Affairs & Safety Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgens Global Regulatory Affairs & Safety (GRASS) department at our Thousand Oaks headquarters is looking for a graduate student interested in a 10 12 week internship. The intern will be responsible for the following: 1. Develop a template to gather information on the regulatory Chemistry, Manufacturing and Controls (CMC) landscape in targeted emerging market countries 2. Working with existing regulatory CMC teams, update existing guidelines to reflect those findings 3. Make recommendations on how to optimize our module 3 guidelines 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 Bachelors Degree required. Must be in the process of obtaining a MS degree in Biology, Chemistry, Engineering or Regulatory Affairs 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 at the time the internship begins; 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 MS in chemistry, biology, engineering or regulatory science Life Sciences / Biopharmaceutical experienceUnited StatesAmgen2012-02-01 02:27:00CaliforniaCAThousand Oaks, CA26231387http://www.amgen.jobs/xml/26231387/jobUSAThousand OaksAuto req 13012BR Job Posting Title Specialist Space Planning Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Global Asset Planning (GAP) is responsible for the Planning, Design, and utilization of Amgens worldwide portfolio. GAP has three basic elements: Strategic Planning, Real Estate, and Occupancy Planning. This position is in the Occupancy planning area. Responsible for space planning and business unit allocations to include function profiles, space allocations, project planning, and space planning committee coordination, presentation to and negotiation with higher levels of management to establish solutions to space issues. Interface with functions at local and corporate level, developing function profiles for all Management Centers, Departments, and work groups associated with the assigned site or functional area. Profiles will include both headcount driven and non-headcount driven space requirements. The successful candidate may support space planning at other sites as needed. Based on function profiles and revised staffing projections, develop five-year plans on an annual basis that include appropriate adjacency, building loading, and stacking plans, space projections, tactical plans and projected project list for the next five years. Negotiate with senior management within assigned business units for resolution of space conflicts. Serve as primary point of contact between Site operations and assigned business unit with respect to space needs and issues. Take primary responsibility for allocation of space to assigned business units. Assume a leadership role in Site or Area Space Planning Committees composed of representatives from client groups, Site Leadership, Site operations, and Area Finance. Develop (in conjunction with others) project scopes and justifications, including analytical support, presentations, illustrative sketches and graphics. Serve as client, corporate, and master plan advocate in project teams. Resolve conflicts between constituencies as required. Apply and maintain facility standards and policies Basic Qualifications Doctorate degree OR Masters degree and 3 years of directly related experience OR Bachelors degree and 5 years of directly related experience OR Associates degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications Bachelors Degree in Architecture, Facilities Management, Business, or the equivalent 7 years experience in space planning or the equivalent Ability to assess needs and create priorities within highly multitask oriented environment. Highly facile at taking immediate actions to resolve issues and effectively communicate results. Demonstrated analytical and problem solving skills Demonstrated ability to anticipate conflicts and resolve them. Able to develop creative solutions under highly stressful conditions using influencing skills Good communications skills both oral and written poise, diplomacy and polish. Must be able to network with all levels of Amgen Highly polished presentation and negotiation skills with strong professional customer service presence Demonstrated ability to work successfully in teams Excellent graphic skills Proven project leadership Able to read the system and promote change within the Amgen environment to support AmgenUnited StatesAmgen2012-01-24 18:18:38CaliforniaCAThousand Oaks, CA26073196http://www.amgen.jobs/xml/26073196/jobUSAThousand OaksAuto req 8316BR Job Posting Title Director, Systems Engineering - Device Engineering Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position reports into the Drug Delivery Systems (DDS) group within the Operations Organization in Thousand Oaks. The successful Director of Systems Engineering will build and lead a team responsible for capturing product requirements from stakeholders, designing system architectures and interfaces, facilitating communication between functional teams, and driving development and system test practices. The Director will leverage past experience and strong communication skills to collaborate closely with marketing, regulatory, quality, and manufacturing. Work with upper management to determine long term product, skill, and organizational needs. Assure that the products enter the field in a known and reliable state. Provide leadership for system testing, verification, validation, and risk management of medical device products. Coordinate internal and external design and test efforts. 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. This position should also have the following experiences: Stays abreast of emerging technologies, explores opportunities for implementation, and plans for integration within existing portfolio. Participate in system and components development process by identifying potential weak points, and develop solutions based on engineering judgment, inputs from experts, customers, suppliers and other systems partners. Drive engineering process in a highly regulated environment. Develop, procure, and use analysis tools for system analyses and modeling, and coordinate system level analyses with project and functional teams. Ensure information flow in a cross-functional matrix teams (internal and external), as appropriate to facilitate work flow, efficiency and quality of work results. Manage projects and activities in a multiple project environment with high demand schedules. Work with marketing, human factors, and customers to develop and evaluate new product features and user interfaces. Interface with customers to ensure customer satisfaction and address issues or observations as needed. Work with hardware engineering and system engineering to ensure design/product specification completeness and interface functionality. Interact/liaison between multiple departments, organizations, project teams, or other companies to document and ensure product is fully defined and traceable and people involved in product are informed. Identifies and establishes departmental or program objectives and implement following company policies and established procedures that are measureable such that outcomes can be quantified. Identifies and ensures area of responsibility complies with most current standards and monitors and prepares for pending or proposed standards. Generates documentation, supporting data and data analysis, reports, and presentation materials on departmental, project, or other company related activities and needs Prepares and gives or facilitates technical reviews and discussions, technology demonstrations, and presentations to company internal or company external organizations, teams, or individuals. Prepares and participates in briefings, technical meetings, tactical or strategic planning with other functional areas or upper management. Basic Qualifications Doctorate degree & 4 years of knowledge or data management experience OR Masters degree & 8 years of knowledge or data management experience OR Bachelors degree & 10 years of knowledge or data management 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 Engineering Management, or other Engineering/Life Sciences and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments. MS in Engineering Management, or other Engineering/Life Sciences Minimum of 8+ years experience working in cross-functional roles in the development of embedded systems design, verification and validation. Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools. Powerful problem-solving, risk assessment, and negotiation skills expected. Experience with complex, cross-functional projects desired. Experience with leading and managing development activity across multiple departments in support of enterprise wide projects. Proven ability to apply situational leadership concepts across various intra and inter-departmental matters. Strong oral/ written communication skills and interpersonal skills. Demonstrated time management, decision making, presentation and organization skills required. Excellent PC skills Previous Experience in a medical device or biotech industry. Background in engineering and commercialization process with injectable devices, and experience in or knowledge of processes for the production of novel formulation is also desired. Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. Industrial 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). Experience or knowledge in the process development of combination product aspects of these systems for macromolecules is desired. General knowledge of regulatory, marketing, business development and quality aspects of drug delivery device/system development is also desired. Experience with partnerships between pharmaceutical and drug delivery companies. Deep background in system engineering methodologies, particularly system specification, verification and validation strategies. Background in product life-cycle management from early research through development. Prefer experience with Requisite Pro, DOORS, Enterprise Architect (or similar), SysML/UML, Surround SCM (or similar), TestTrack, Rational ClearQuest. Familiarity with lean manufacturing and six-sigma methodology. Ability to converse technically with mechanical, electronic, software, clinical, regulatory, radio frequency, and quality engineering disciplines. Lead projects from development through the 510k and PMA approval process. Familiar with medical product development, design control process, quality and regulatory environments, and the following standards: o US Good Manufacturing Practices 21CFR820 o Quality Management ISO 9001 & 13485 o Risk Management ISO 14971 o EU Medical Device requirements Council Directive 93/42/EEC o Medical Electrical Equipment EN 60601 Demonstrated Competencies/Skills: 1) Independent thinker with demonstrated skills working in teams or leading project teams 2) Strong Interpersonal and communication skillsUnited StatesAmgen2011-03-31 22:42:32CaliforniaCAThousand Oaks, CA20434986http://www.amgen.jobs/xml/20434986/jobUSAThousand OaksAuto req 11714BR Job Posting Title Reimbursement, Director (Global Pricing Analytic Group) Career Category Government Affairs Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description In the context of a rapidly evolving pricing environment, Amgen’s increasing emphasis on geographic expansion and acquisition/licensing as drivers of growth, and a commitment to demonstrate product value, Amgen requires an increasingly sophisticated pricing analytic capability to support strategic pricing as an important source of competitive advantage. The Global Pricing Analytics Group is a new team that will develop such an analytic capability to position Amgen for future success against this business-critical imperative. This position is a key leadership position in this new team. The successful candidate will bring a comprehensive knowledge of the business, a keen understanding of the global (US and ex-US) payer environment, and outstanding technical and quantitative analysis skills to help establish and ensure the ongoing success of the group. Success will require deep collaboration with and achievement of synergies between Global Pricing and Payor Planning, ICO Pricing and Contracting, U.S Pricing and Contracts, and other key stakeholder groups. Position Responsibilities/Accountabilities: • Assists in the development of key aspects of the Global Pricing Analytics capability, including a “business architecture” defining how the capability will operate and an “implementation roadmap” which defines how the capability will be built out and deliver value over time. • Provides commercial leadership over building and maintaining robust analytic platform architecture—including a global price and reimbursement outcomes database—to examine price as a key strategic lever across the portfolio and across regions. • Assists in identifying or developing “best practice” analytic methodologies to address key issues like new product launch sequencing, price erosion impact, optimal emerging markets pricing, objective price assumptions in MA valuation/LRP, etc. and works to embed best practice approaches across the global organization. • Leads collaboration between assigned stakeholder groups (GP3, ICO Pricing, US Pricing and Contracts, etc.) to ensure pricing analytics are based on a comprehensive view and create pricing and contracting strategies that are appropriately aligned. • Leads on-time delivery of pricing analytic projects to support NACO, ICO, and GP3 end-users, including understanding implications of competitive price actions, emerging price/coverage/payment strategies, legislative proposals, cross-regional/portfolio price divergence, etc. • Assess implications of price and contracting strategies on LRP, price bands, and price-to-value ratio by pressure testing regional assumptions and providing an objective assessment of the LRP as it relates to pricing in the context of global payer trends and evolving assessments of the value of products and innovation. 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 • 6 years of direct managerial and/or leadership experience (leading teams, programs, resources). • Proven ability to manage in a highly fluid, interactive, matrixed environment and build strong, successful business partnerships with regional and global colleagues. • Ability to translate complex situation analyses of the external pricing and reimbursement environment and Amgen’s product portfolio to develop relevant analytic questions. • Ability to translate analytic output into potential price and contracting solutions (e.g., new pricing models, risk-sharing, etc.) with quantification of impact for Amgen, providers, and payers. • Strong strategic thinker capable of translating analytic output into strategic insights that will drive the business and proactively define and develop new capabilities to ensure Amgen pricing success in the changing environment. • Excellent conceptual problem solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution. • Excellent technical skills and fluency with spreadsheet model design and/or software development, database design, and pricing applications. • Excellent oral/written communications skills and interpersonal skills with a credible “Senior Management presence”; able to communicate at all organizational levels. • Strong understanding of the US and global payer environment, including coverage and reimbursement, pricing, value drivers, formulary management, health technologies assessment, and health policy. • Deep understanding of the U.S. Government and Commercial reimbursement environment. • Previous international (ex-US) assignment and/or Business Development experience and/or emerging markets experience desirable.United StatesAmgen2012-02-06 18:48:21CaliforniaCAThousand Oaks, CA26331646http://www.amgen.jobs/xml/26331646/jobUSAThousand OaksAuto req 13770BR Job Posting Title Exec Dir Global Operations TA Head Career Category Operations Employee Subgroup Executive FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Therapeutic Area Head (TAH) represents Operations as a key member of Amgen’s Therapeutic Area Steering Committee (TASC). Working closely with all TASC members the TA Head provides executive leadership to assist in setting the strategic direction for the TA, while ensuring that business and technical decisions impacting Operations are carefully considered cross-functionally as part of the product commercialization strategy, for the products within that Therapeutic Area. The TA head is also responsible for ensuring that Operation’s issues, budget requirements and priorities are appropriately represented at the TASC. The TA head is responsible for ensuring that critical GOT decisions and recommendations are crisply framed at GORC, ERB and XRB meetings. The TA Head also serves as a Functional Head within Global Operations Planning for his / her TA. This includes providing leadership, general management and supervision to GOLs on all Operations aspects including ongoing product supply, strategic product sourcing, quality, compliance, manufacturing technology assessment, manufacturing process economics, competitive intelligence, etc. The TA Head is also responsible (in collaboration with other TA Heads) for executing to the Charter and Mission of the Global Operations Planning (GOP) Department, and ensuring progress against GOT goals and milestones through resources existing within GOP (i.e GOL’s and GOPM’s). 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 in a matrixed environment) Preferred Qualifications • Experience as a GOL for a commercial product, with demonstrated track record for successful / effective execution • Experience within Amgen Operations of leading a Function or Plant, including supervision of senior staff, with a demonstrated track record • 15+ years of experience in the biotechnology/pharmaceutical industry including leadership roles (e.g., team leadership or functional leadership roles) in key Operations functions (e.g., Process Development, Manufacturing, Quality, and / or Global Operations Planning Department) • Advanced degree in Science or Engineering • Additional diverse assignments in Operations support (Planning, Compliance, Engineering, etc.) and ex-Operations functions (Regulatory Affairs, Clinical Development, R&D Project Management, Pharmaceutics, Finance, etc.) • Proficient with pharmaceutical product commercialization and life cycle management; ability to recognize strategic implications of complex product development activities and manage them cross-functionally • Authoritative command of complexity and ambiguity, ability to collect, digest and assemble information to enable relevant business analyses and influence decision-making • Excellent Executive communication track record; ability to communicate vertically and horizontally through multiple channels, leverage contact network to motivate diverse teams, and enable cross-functional collaborationUnited StatesAmgen2012-02-06 18:49:16CaliforniaCAThousand Oaks, CA26331678http://www.amgen.jobs/xml/26331678/jobUSAThousand OaksAuto req 12361BR Job Posting Title Regulatory Affairs Director Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Therapeutic Area team facilitates product development and global registration to achieve the desired regional labeling by developing and executing regulatory strategies and effective regulatory agency interactions. The Global Regulatory Leader (GRL) will lead one or more programs in the Therapeutic Area team within Amgens Regulatory Affairs department. Key Activities: - Participate in the development of product label and core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent - Develop global Regulatory Plan through integration of regional regulatory strategies and provide regulatory input into the global Strategic Plan - Provide input into SCD, study protocols, statistical analysis plans, clinical study reports and other documents used to support product development and registration - Provide leadership for planning and implementing regulatory filings i.e. FIH, CTD, label extensions - Ensure effective regulatory agency communications by chairing core regulatory and cross functional teams - Ensure consistent communication of information to all ethics committees and Health Authorities - Ensure global consistency of evidence based product communication - Ensure effective regulatory agency communications by chairing core regulatory and cross functional teams - Lead GRT to develop and execute team goals - Provide education and training on regulatory strategies and compliance issues to other PST functions - Collaborate with PST to develop product registration strategies and development plans aimed at achieving regulatory approval and product labeling - Conduct contingency regulatory planning/risk assessment for product development strategies and agency interactions - Monitor and assess impact of relevant global regulations, guidance, current regulatory environment and competitor labeling - Provide guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional approval, compassionate use and pediatric plan) - Ensure creation and maintenance of product regulatory history documents through IMR and appropriate archiving of all regulatory documents and agency communication Basic Qualifications - Doctorate degree & 4 years of directly related experience OR - Masters degree & 8 years of directly related experience OR - Bachelors degree & 10 years of directly related experience Preferred Qualifications - Regulatory submissions experience - Experience interacting with regulatory agencies - Oncology Therapeutics Knowledge and Skills - Demonstrated ability to lead a team - Strong communication skills both oral and written - Ability to understand and communicate scientific/clinical informationUnited StatesAmgen2011-11-28 21:31:23CaliforniaCAThousand Oaks, CA25067025http://www.amgen.jobs/xml/25067025/jobUSAThousand OaksAuto req 12497BR Job Posting Title Clinical Research Medical Director - Bone Therapeutic Area 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 (Bone Therapeutic Area) 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 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 issues Basic Qualifications - MD - Two (2) or more years of clinical research experience and/or basic science research 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), preferably with endocrinology, rheumatology, or internal medicine background.United StatesAmgen2011-11-07 20:59:36CaliforniaCAThousand Oaks, CA24732545http://www.amgen.jobs/xml/24732545/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 The Biomedical Data Stewardship role reports into the Director, Global Biomedical Data Sciences - Biomedical Data Stewardship. This role can be located at Amgen's Thousand Oaks, California headquarters or Amgen's South San Francisco site, or possibly be remote-based. However, the preference is for the candidate to be located at Amgen's Thousand Oaks headquarters. - Drive and facilitate the expansion of data standards across Amgen Global Development - Lead, motivate and develop cross-functional teams to develop end-to-end (Protocol ? CSR) data standards that meet all stakeholder requirements - Collaborate cross-functionally and within GBDS Data Stewardship to drive forward compliance with standards, processes and training - Develop and maintain strong working relationships with key stakeholders - Oversee data standards implementation - ensure technical quality - ensure consistent approaches in the adoption of data standards - provide hyper care support for study teams during data standards implementation - Data Standards Governance team member - Track key metrics and reporting to GBDS and R&D Senior Management - Drive efficiencies in the investigation and implementation of new technologies Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Masters degree & 6 years of directly related experience OR - Bachelors degree & 8 years of directly related experience OR - Associates 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 hardwareUnited StatesAmgen2011-11-28 21:33:28CaliforniaCAThousand Oaks, CA25067075http://www.amgen.jobs/xml/25067075/jobUSAThousand OaksAuto req 12830BR Job Posting Title Observational Research Senior Manager Epidemiology Health Outcomes Career Category Clinical Development 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 Therapeutic Area Director or Executive Director or International OR Leader. 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 companys 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 signal detection and management Provides 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 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 Masters degree & 6 years of directly related experience OR Bachelors degree & 8 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Masters (PhD preferred) degree in Epidemiology or other subject with high observational research content or Medical degree with observational research experience 6 years experience in observational research Record of publications in observational research or clinical journals 3 years experience with Medical or Doctorial degree Experience in the design, execution, and analysis of observation 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 dataUnited StatesAmgen2011-11-28 21:33:33CaliforniaCAThousand Oaks, CA25067077http://www.amgen.jobs/xml/25067077/jobUSAThousand OaksAuto req 9759BR Job Posting Title Clinical Research Medical Director - Cardiovascular Therapeutic Area 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 (Cardiovascular Therapeutic Area) 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 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 issues Basic Qualifications - MD - Two (2) or more years of clinical research experience and/or basic science research Preferred Qualifications - MD plus accredited residency in Cardiology, 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)United StatesAmgen2011-05-03 23:05:31CaliforniaCAThousand Oaks, CA21056600http://www.amgen.jobs/xml/21056600/jobUSAThousand OaksAuto req 10153BR Job Posting Title Category Manager - Sourcing, Drug Delivery Device Systems Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Category Manager resides in Global Strategic Sourcing (GSS). Reporting to the GSS Director, the Category Manager will initially be responsible for the strategic sourcing and ongoing supplier management of medical device systems and related materials used in the manufacturing of Amgens human therapeutics. Working within a matrix environment, the Category Manager is responsible for applying in-depth disciplinary knowledge, business acumen and subject matter expertise to deliver strategic sourcing objectives. The Category Manager employs category management, project management and change management techniques to effectively deliver strategic sourcing initiatives. The Category 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 OR Masters degree & 3 years of directly related experience OR Bachelors degree & 5 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications MBA preferred 3+ years of Strategic Sourcing experience 2+ years Biotech/Pharmaceutical experience 5+ 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 Manufacturing Operations and Engineering areas 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 anticipate problems requiring evaluation of intangible variables 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 identify roadblocks and effectively identify and execute resolution 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 Significant success as a leader in primary pharmaceutical drug product packaging, drug product delivery, critical raw material and /or medical device developmentUnited StatesAmgen2011-08-27 19:01:54CaliforniaCAThousand Oaks, CA23290896http://www.amgen.jobs/xml/23290896/jobUSAThousand OaksAuto req 10997BR Job Posting Title Corporate Communications Director, Compliance, Thousand Oaks, CA Career Category Compliance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Corporate Communications Director, Compliance position is responsible for developing and executing the communications strategy for Amgens Worldwide Compliance & Business Ethics function. This individual is responsible for ensuring that all staff and stakeholders are aware of the compliance programs objectives, their own responsibilities under the program, and other key program elements to enable compliant behavior and decision-making and to enhance performance. The Corporate Communications Director works cross-functionally with stakeholders in Commercial, R&D, Human Resources, Law, Training, Marketing and other groups within WC&BE to ensure communications are clear, impactful, digestible, appropriately timed, and incorporated into appropriate messaging vehicles and tools. Responsibilities include: - Developing and executing the communications requirement of the U.S. Healthcare Compliance Program. In addition, responsible for ensuring that all staff and stakeholders are aware of the compliance programs objectives, their own responsibilities under the program, and the other program elements to enable compliance behavior and decision making. - Developing and managing WC&BEs annual communications plans based on the compliance environment, training and policy needs, business events and activities, and other factors. - Developing and implementing communications and change management plans to support policy and SOP changes and implementation of significant cross-functional compliance initiatives. This includes creating materials and messages that support and enable appropriate compliance behavior, interactions, and decision-making for both internal and external audiences. The Director works cross-functionally with stakeholders in Commercial, R&D, Human Resources, Law, Training, Marketing, and other groups within WC&BE. - Leading and managing the Communications and Change Management Workstream for the Aggregate Spend Project - Supporting Amgens Senior Vice President & Chief Compliance Officer by developing presentations for internal and external speaking engagements - Supporting communications efforts of WC&BE departments, with a particular focus on communications relating to Healthcare Compliance issues including proper interactions with members of the U.S. Healthcare Community - Partnering with Policies and Training groups, as well as Healthcare Compliance Operations, to integrate and coordinate efforts, assess policy, training and communication needs, create tools, and manage incoming requests, and formulate meaningful responses - Reviewing communications from other departments regarding compliance, for consistency of voice and messaging in training and communications.Utilizing creative solutions to deliver ongoing reinforcement and ensure messages are relevant, current, and meaningful for each audience group - Developing and managing key messages and developing, executing, and maintaining an authentic, meaningful, and consistent voice for the WC&BE function generally and for Healthcare Compliance specifically - Providing strategic recommendations to Chief Compliance Officer and the WC&BE Senior Leadership Team regarding potential speaking opportunities and developing content for speaking engagements - Preparing and delivering regular management reviews and operating reviews - Allocating resources, managing a budget, and overseeing vendor and agency engagements - Anticipating project challenges, troubleshooting, problem-solving, recommending solutions Basic Qualifications - Bachelors degree & 10 years of directly related experience OR - Masters degree & 8 years of directly related years OR - Doctorate degree & 4 years of directly related experience Preferred Qualifications -Expertise in the design and implementation of communications and change management programs in a global corporate environment - Strategic and creative thinker with the ability to truly understand business challenges and priorities and develop actionable programs that integrate soundly with business objectives - Demonstrated ability working directly with executive management, including the ability to advise, influence and develop effective communications strategies - Understanding of compliance issues facing the pharmaceutical industry, including: Knowledge of the PhRMA Code, OIG Compliance Program Guidance for Pharmaceutical Manufacturers, and OIG/FDA issues relating to the marketing of pharmaceuticals - Organizational savvy and relationship-management skills - Effectiveness working in a fast-paced, matrixed, cross-functional environment - Ability to successfully manage multiple projects at once - Excellent communication skills, including written, verbal and presentationUnited StatesAmgen2011-07-21 21:26:31CaliforniaCAThousand Oaks, CA22546307http://www.amgen.jobs/xml/22546307/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 Amgens data, business intelligence and application strategies. Job Responsibilities 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 - Masters degree & 6 years of directly related experience OR - Bachelors degree & 8 years of directly related experience OR - Associates 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.United StatesAmgen2011-08-24 20:15:19CaliforniaCAThousand Oaks, CA23225778http://www.amgen.jobs/xml/23225778/jobUSAThousand OaksAuto req 10718BR Job Posting Title Sr Mgr Engineering - Device Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Senior Manager is responsible for providing technical leadership to a group of engineers responsible for device development from pre-commercial through commercial support of parenteral biological products. The intended focus will be to manage a team to sustain and improve devices currently on the market. The Senior Manager is responsible to meet key performance metrics, supervise and technically develop direct reports and ensures schedules are completed on time. Also, to ensure Project Teams utilize the Device Commercialization Business Process and Design Controls during the development. Scope will include a wide range of products including; needle protection systems, autoinjectors, and reconstitution systems. Responsibilities -Oversight and execution of drug delivery projects. - Sustaining support for commercialized drug delivery projects. -Global oversight responsibilities of device related project at Amgen sites. -Responsible for engineering aspects of the development and commercialization of drug delivery devices -Work cross-functionally with individuals and project teams in Marketing, Operations, and Development and serve as a primary contact with Amgen's external drug delivery partners. -Work with Amgens partners in the support of device, diagnostics, and ancillary items. Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Masters degree & 6 years of directly related experience OR - Bachelors degree & 8 years of directly related experience OR - Associates 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 MS degree in Mechanical Engineering, or Electrical Engineering or other Engineering/Life Sciences 12 years of experience in engineering specific to the medical device or biotech/pharmaceutical industry. Including 7 years in a management/supervisory role. -Strong background in engineering and commercialization process with injectable devices, and experience in or knowledge of processes for the production of novel formulation is also desired. -Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. -Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. -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 Demonstrated Competencies/Skills: 1) Leadership role in projects and functional areas 2) Independent thinker with demonstrated skills working in teams or leading project teams 3) Strong Interpersonal and communication skillsUnited StatesAmgen2011-12-07 22:26:09CaliforniaCAThousand Oaks, CA25239756http://www.amgen.jobs/xml/25239756/jobUSAThousand OaksAuto req 13071BR Job Posting Title Undergrad Intern Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgens Information System (IS) Department at our Thousand Oaks headquarters located along the southern California coast between Santa Monica and Santa Barbara (40 miles west of Los Angeles) is looking for undergraduate students with outstanding academic records and demonstrated leadership capabilities interested in 10 12 week internship opportunities. An internship in Amgen's IS Department is a hands-on learning experience under the guidance of an IS Manager. Interns are matched to meaningful and challenging projects. Amgen's IS groups support over 19,000 users worldwide. Amgens internship program offers meaningful project experiences that impact patients lives, a collaborative team environment, competitive compensation, housing benefits (for eligible candidates), executive networking events, social networking events, community volunteer project opportunities, on-site fitness center and much more. Internship Description: There are two different opportunities within Amgens Information Systems Organization: IS Programmer Analyst and IS Business Systems Analyst Undergrad Intern. When applying please specify in your cover letter which one you are interested in. IS Programmer Analyst Undergrad Intern: Employs entry level programming, configuration and design techniques that ensure adherence to software development standards, performance efficiency, reliable and maintainable code, and self-documenting programs. This role will leverage a basic understanding of application development methodologies and techniques. Duties & Responsibilities include: drafting and updating detailed project plans for small projects or portions of larger projects. Assists in testing, debugging, maintaining, and documenting components of information systems applications. Gain an understanding of basic business processes and transforms them into programming logic. Follows standard policies and procedures in analyzing situations or data from which answers can be readily obtained. IS Business Systems Analyst Undergrad Intern: Translates business needs into system requirements. This role will leverage the skills to clearly capture and articulate the client's processes, partner with the client to identify process improvement, and translate strategies into information solutions. Duties & Responsibilities include: Drafting and updating detailed project plans for small projects or portions of larger projects. Assists in testing, maintaining, and documenting components of information systems applications. Follows standard policies and procedures in analyzing situations or data from which answers can be readily obtained. Examples of possible internship projects include: Mobile website development Infrastructure and cloud automation work Interactive visualization of data from multiple competitor pipeline databases New direct-to-consumer email campaign deployment Creation of a segregated manufacturing network DMZ Microsoft SharePoint site design, development, and support 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 degree in Information Technology, Information Systems, Computer Science (e.g., CS, CPE, SE), Engineering, or other technical/scientific discipline. Must be graduating between December 2012 and Summer 2013 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 currently enrolled at an accredited four-year college or university as a full time student 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 1 or more years relevant work experience Biotechnology, pharmaceutical or health care industry experience Intermediate knowledge of Microsoft Word, Excel and Power Point Strong organizational, project management, detail oriented, analytical and quantitative skills Demonstrated personal initiative, self-motivation, flexibility and adaptability Ability to effectively operate independently, across functional lines, and with both internal and external customers Coursework in one or more the following areas: o Business Systems analysis, RUP, UML and other SDLC processes o Application Development o Database Modeling o Web Design and Development o IT Management o Management of ASP environments (Application Service Provider) o B2B Collaboration o Coursework in Enterprise systems such as configuration and management of ERP, CRM systemsUnited StatesAmgen2011-12-08 21:29:40CaliforniaCAThousand Oaks, CA25259592http://www.amgen.jobs/xml/25259592/jobUSAThousand OaksAuto req 13072BR Job Posting Title Grad Intern - IS Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Internship Summary: Amgens Information System (IS) Department at our Thousand Oaks headquarters located along the southern California coast between Santa Monica and Santa Barbara (40 miles west of Los Angeles) is looking for Graduate students with outstanding academic records and demonstrated leadership capabilities interested in 10 12 week internship opportunities. An internship in Amgen's IS Department is a hands-on learning experience under the guidance of an IS Manager. Interns are matched to meaningful and challenging projects. Amgen's IS groups support over 19,000 users worldwide. Amgens internship program offers meaningful project experiences that impact patients lives, a collaborative team environment, competitive compensation, housing benefits (for eligible candidates), executive networking events, social networking events, community volunteer project opportunities, on-site fitness center and much more. Internship Description: There are two different opportunities within Amgens Information Systems Organization: IS Programmer Analyst and IS Business Systems Analyst Grad Interns. When applying please specify in your cover letter which one you are interested in. IS Programmer Analyst Grad Intern: Employs entry level programming, configuration and design techniques that ensure adherence to software development standards, performance efficiency, reliable and maintainable code, and self-documenting programs. This role will leverage a basic understanding of application development methodologies and techniques. Duties & Responsibilities include: drafting and updating detailed project plans for small projects or portions of larger projects. Assists in testing, debugging, maintaining, and documenting components of information systems applications. Gain an understanding of basic business processes and transforms them into programming logic. Follows standard policies and procedures in analyzing situations or data from which answers can be readily obtained. IS Business Systems Analyst Grad Intern: Translates business needs into system requirements. This role will leverage the skills to clearly capture and articulate the client's processes, partner with the client to identify process improvement, and translate strategies into information solutions. Duties & Responsibilities include: Drafting and updating detailed project plans for small projects or portions of larger projects. Assists in testing, maintaining, and documenting components of information systems applications. Follows standard policies and procedures in analyzing situations or data from which answers can be readily obtained. Examples of possible internship projects include: Mobile website development Infrastructure and cloud automation work Interactive visualization of data from multiple competitor pipeline databases New direct-to-consumer email campaign deployment Creation of a segregated manufacturing network DMZ Microsoft SharePoint site design, development, and support 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 Basic Qualifications: Must be in the process of earning a Masters or Ph.D. degree in Information Technology, Information Systems, Computer Science (e.g., CS, CPE, SE), Engineering, or a other technical/scientific discipline Must be graduating between December 2012 and Summer 2013; 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 currently enrolled at an accredited four-year college or university as a full time student; 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 Preferred Qualifications: 1 or more years relevant work experience Biotechnology, pharmaceutical or health care industry experience Intermediate knowledge of Microsoft Word, Excel and Power Point Strong organizational, project management, detail oriented, analytical and quantitative skills Demonstrated personal initiative, self-motivation, flexibility and adaptability Ability to effectively operate independently, across functional lines, and with both internal and external customers Coursework in one or more the following areas: o Business Systems analysis, RUP, UML and other SDLC processes o Application Development o Database Modeling o Web Design and Development o IT Management o Management of ASP environments (Application Service Provider) o B2B Collaboration o Coursework in Enterprise systems such as configuration and management of ERP, CRM systemsUnited StatesAmgen2011-12-08 21:29:08CaliforniaCAThousand Oaks, CA25259567http://www.amgen.jobs/xml/25259567/jobUSAThousand OaksAuto req 13114BR 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 Independently provide and/or direct the characterization of process optimization strategies and/or trouble shooting of operational issues. Apply advanced and diverse engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components and/or systems. This position will provide solutions to a variety of highly complex technical problems of large scope, independently evaluate, select, and/or modify standard engineering techniques, procedures and criteria, perform assignments that have loosely defined objectives that require investigation of a large number of variables and interpret and execute policies and procedures. The position will be involved in the selection of primary and secondary packaging materials for both large and small molecules product, performing technical assessments and studies to justify the selected material, writing technical specifications and Bill of Materials for the components and product to be packaged, lead the team in technology transfer from clinical to commercial operations for both components and equipment processes, ensure that line trials and packaging validation is conducted prior to introduction and resolving any packaging related issues at the sites. The candidate will be expected to lead a team and may have direct reports. Basic Qualifications Doctorate degree & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree & 8 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelors degree in Engineering, Science or related technological field with a minimum of 10 years of work experience preferred, with previous experience in the pharmaceutical or biotechnology area. Demonstrated leadership in a wide range of packaging related technologies with strong fundamental knowledge of primary and secondary packaging systems & processes, manufacturing fill finish equipment & processes, material science, and quality systems are essential. The successful candidate will have excellent organizational, project management, technical, problem solving and communication (written & verbal) skills. The candidate must have demonstrated ability to work with a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule. The candidate must also have demonstrated ability to effectively communicate to a diverse audience, at multiple levels within the company, through various formats (orally, powerpoint, etc.,). In addition, candidates must possess strong interpersonal skills, high level of client focus, and an ability to adapt to a rapidly changing environment. Direct experience with pharmaceutical or bio-technology environment is required. Candidate must demonstrate solid technical presentation skills, test protocol writing, organization, analytical problem solving. Must be a proven and experienced leader and have the ability to successfully manage a multitude of projects. The candidate is also expected to encourage and promote the development of innovative, cost effective packaging systems and able to translate industry trends to business opportunities at Amgen. The ability to travel domestically and international is required.United StatesAmgen2011-12-15 22:12:35CaliforniaCAThousand Oaks, CA25390251http://www.amgen.jobs/xml/25390251/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 Masters degree & 3 years of experience directly related to the job OR Bachelors degree & 5 years of experience directly related to the job OR Associates 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 Masters 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.United StatesAmgen2011-11-01 22:17:12CaliforniaCAThousand Oaks, CA24526976http://www.amgen.jobs/xml/24526976/jobUSAThousand OaksAuto req 13435BR Job Posting Title Grad Intern - Small Molecule Process and Product Development (SMP&PD) Analytical Research & Development Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Program Summary: Amgen's corporate headquarters is located along the southern California coast between Santa Monica and Santa Barbara (40 miles west of Los Angeles). Amgens internship program offers meaningful project experiences that impact patients lives, competitive compensation, housing benefits (for eligible candidates), executive networking events, social networking events, community volunteer project opportunities, on-site fitness center and much more. Job/Project Description: Amgens Small Molecule Process and Product Development (SMP&PD) Analytical Research & Development department at our Thousand Oaks headquarters is looking for a graduate student interested in a 10 12 week internship. The importance of this work is to develop a platform-based approach for the assessment and understanding of analytical chromatographic methods. Through the principles of quality by design (QbD) the platform will support high performance liquid chromatography (HPLC) method development, validation and transfer, and ensure the robustness and ruggedness of a HPLC method. The summer intern will conduct research on an automated HPLCto apply principles of QbD in the development of analytical methods. The automated HPLC system combined with statistical analysis tools will aid in understanding multivariable effects on changing method conditions. This work is important to identify critical method parameters and failure edges and will lead to ensuring robust and reliable analytical methods in drug development. 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 Candidate must be in the process of obtaining a Graduate degree in Chemistry (Analytical, Organic, Synthetic, Physical, etc..) or Biochemistry Introductory coursework in chemistry and laboratory techniques is required. 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 Theoretical understanding of chromatographic techniques (specifically high performance liquid chromatography). Basic understanding of statistics and/or statistical software packages Experience conducting undergraduate research Experience with hands-on chromatographic techniques in support of undergraduate researchUnited StatesAmgen2012-01-19 22:54:29CaliforniaCAThousand Oaks, CA25996897http://www.amgen.jobs/xml/25996897/jobUSAThousand OaksAuto req 13438BR Job Posting Title Undergrad Intern - Small Molecule Process and Product Development (SMP&PD) Chemical Process Research and Development Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Program Summary: Amgen's corporate headquarters is located along the southern California coast between Santa Monica and Santa Barbara (40 miles west of Los Angeles). Amgens internship program offers meaningful project experiences that impact patients lives, competitive compensation, housing benefits (for eligible candidates), executive networking events, social networking events, community volunteer project opportunities, on-site fitness center and much more. Job/Project Description: Amgens Small Molecule Process and Product Development (SMP&PD) Chemical Process Research and Development department at our Thousand Oaks headquarters is looking for an undergraduate student interested in a 10 12 week internship to collect and/or generate biopharmaceutical properties for internal and external compounds. In addition, compile dose range, formulation information and preclinical and/or clinical data into a list. The data set will be used to establish a database with Microsoft Access software. The database will allow users to search compounds with individual or combinational biopharmaceutical properties, compare the compounds with similar or different biopharmaceutical properties and list their development results such as dose range, dosage form and clinical data. In addition, the database will provide some clinical predictions, and suggest a formulation selection and development strategy. Results will be presented in a seminar and summarized in a report and could be used as the basis for publications. 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 obtaining an Undergraduate degree in General Chemistry and computational background 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 currently enrolled at an accredited graduate college or university as a full time student Must have completed at least one full year of study; Must have not yet graduated; Must be pursuing an applicable degree or course of study; 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 Pharmaceutical knowledge and possible database training for Microsoft AccessUnited StatesAmgen2012-01-19 22:53:51CaliforniaCAThousand Oaks, CA25996853http://www.amgen.jobs/xml/25996853/jobUSAThousand OaksAuto req 13440BR Job Posting Title Grad Intern - Molecule Process and Product Development (SMP&PD) Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Program Summary: Amgen's corporate headquarters is located along the southern California coast between Santa Monica and Santa Barbara (40 miles west of Los Angeles). Amgens internship program offers meaningful project experiences that impact patients lives, competitive compensation, housing benefits (for eligible candidates), executive networking events, social networking events, community volunteer project opportunities, on-site fitness center and much more. Job/Project Description: Amgens Small Molecule Process and Product Development (SMP&PD) Business Operations department at our Thousand Oaks headquarters is looking for an graduate student interested in a 10 12 week internship to support optimizing the overall SMP&PD contract manufacturing process by collecting and analyzing business data, conducting stakeholder interviews, performing benchmarking analysis and involving in actual contract manufacturing projects. Responsible for the following: Analyze historical and forecasted outsourcing data (time, cost, quality etc) to provide metrics and trending analysis Provide key improvements recommendations of SMP&PD outsourcing business process through conducting key stakeholder interviews and perform benchmarking analysis on small molecule manufacturing outsourcing Responsible for some deliverables of outsourcing projects 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 obtaining a Masters degree in Chemistry or Chemical Engineering 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 Strong interest to pursue advanced business degree and/or business experiences Strong analytical, communications and interpersonal skills Strong business acumen Experiences in pharmaceuticals small molecule process and product development, manufacturing or quality control/assurance Experiences in contract and vendor management Experiences in business process development and optimization, continuous improvement and operational excellenceUnited StatesAmgen2012-01-19 22:54:33CaliforniaCAThousand Oaks, CA25996900http://www.amgen.jobs/xml/25996900/jobUSAThousand OaksAuto req 13478BR 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 Responsible for supporting protein Drug Product (DP) manufacturing at Amgen contracted manufacturing sites including process performance monitoring; implementation of process improvement strategies; development of process models. Act as a 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 DP manufacturing operations with technical evaluation of NC/CAPA, scale up, validation, and technology transfer. Troubleshoot issues with DP processing technologies and equipment. Develop and characterize DP processes and transfer technology to commercial DP sites. Conduct FMEA for DP 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 & 2 years of directly related experience OR Masters degree & 6 years of directly related experience OR Bachelors degree & 8 years of directly related experience OR Associates 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 Engineering 10 + 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. Experience including statistical analysis and design of experiments, process characterization, scale-up, and/or technology transfer experience. Strong problem solving, trouble shooting, and communication skills are preferred. Ability to participate in global cross-functional teams and work effectively in a highly matrixed team environment. Participate as author for process transfer documentation, technical reports, batch records, GMP documentation and regulatory filings. 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. 2 + years experience in project management including the ability to manage multiple projects, strategically prioritize activities and leading cross functional teams within Operations/Manufacturing.United StatesAmgen2012-01-19 22:54:28CaliforniaCAThousand Oaks, CA25996896http://www.amgen.jobs/xml/25996896/jobUSAThousand OaksAuto req 12938BR Job Posting Title Business Performance Mgr Career Category Finance Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role will support Amgen’s executive leadership and 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 key leadership and staff in all areas of the company, including internal and external stakeholders. Travel requirements may vary as they depend on specific project assignments. Key Responsibilities • Work with executives in the identification of improvement opportunities and competitive strategies Translate strategy into challenging actionable objectives to effectively drive project teams • Identify and remove barriers by working with internal and external stakeholders • Lead and manage cross functional initiatives while delivering high-quality and timely results • Conduct project scoping, execution strategy, process improvement, and change management activities • Serve as primary interface with sponsors and interact with personnel in all areas of the company. About Amgen and the Business Performance Team Amgen is a Fortune 500 company and a leader in the biotechnology industry. For more than 25 years, the company has tapped the power of scientific innovation to advance the practice of medicine and to help patients fight serious illnesses. We currently have an opportunity for a Manager in the Business Performance Team. The group executes high priority initiatives focused on increasing Amgen’s competitive position, improving productivity, and delivering economic value. 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 degree in science, technology and / or business - Experience at a top five management consulting firm - Strong presence with Senior Executives including ability to communicate effectively on a prepared and adhoc basis - 3+ years of experience in biotechnology / pharmaceutical development, regulatory, manufacturing, marketing, or policy development - 3+ years of experience in strategic, scientific, or business operations - Experience with executive communication to include written and oral presentations - Excellent data-driven problem solving and analytical skills - Experience leading large initiatives in multiple functional areas of a complex organization - Excellent conceptual problem solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution - Experience applying change management methodologies - Experience in financial modeling and budgeting.United StatesAmgen2011-11-29 18:32:27CaliforniaCAThousand Oaks, CA25085025http://www.amgen.jobs/xml/25085025/jobUSAThousand OaksAuto req 13247BR Job Posting Title Grad Intern - Global Health Economics Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Global Health Economics department at our Thousand Oaks, CA headquarters is looking for a graduate student interested in a 10 – 12 week internship. The intern will be responsible for the following project examples: 1. Develop the study research design and protocol of an observation study to evaluate lost productivity and unmet need in patients with psoriasis. The student will learn how to apply research design skills and statistics to the development of a study protocol to evaluate lost productivity. The student will also learn how to translate the strategic needs of the product to actionable objectives and gain a better understanding of health plan data in the US 2. Review and modify a level 1 model for Ulcerative Colitis. This project will apply the student’s basic knowledge of economic assumptions and the model structure for initial pricing analyses. 3. Review and modify a level model for Crohn’s Disease. This project will apply the student’s basic knowledge of economic modeling to develop initial models for Cron’s Disease. The student is expected to learn how best to develop basic model assumptions and the model structure for initial pricing analyses. 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 have completed a Bachelor’s Degree in Science, Economics or a Degree in Pharmacy. Must be in the process of obtaining a Masters or Doctoral Degree in Health Services Research, Health Outcomes Research, or Pharmacy Administration. 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 year of study at the time the internship begins • 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 • Experience with research design of prospective and retrospective studies, statistics, economic modeling, survey research, reimbursement submission is preferredUnited StatesAmgen2012-02-09 23:45:38CaliforniaCAThousand Oaks, CA26445043http://www.amgen.jobs/xml/26445043/jobUSAThousand OaksAuto req 13248BR Job Posting Title Grad Intern - Global Health Economics Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Global Health Economics (GHE) department at our Thousand Oaks, CA headquarters is looking for a graduate student interested in a 10 – 12 week internship. The intern will be expected to complete the following tasks under the supervision of a hiring manager and study lead: 1) Developing statistical analysis plan and table shells together with the study lead based on Research Project Plan 2) Conducting data analysis with detailed documentation 3) Providing completed table shells 4) Presenting the analysis results at a GHE “Lunch and Learn” seminar The intern will get the opportunity to perform a health economics project using real world health care data, learn the cultural environment of Amgen through interacting with health economists, epidemiologists, biostatisticians at Amgen, and become a co-author on publications based on study. 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 obtaining a master’s or doctoral degree in economics, pharmacy, pharmacoeconomics, health policy, health economics, health services research, or health outcomes research Minimum 1yr of experience in statistical programming language SAS or Stata Minimum 1yr of experience in managing and analyzing large scale secondary databases 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 year of study at the time the internship begins • 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 • Experience in analyzing administrative claims and medical records • Experience in conducting client-funded research projects • Familiarity with oncology therapeutic areaUnited StatesAmgen2012-02-09 23:45:58CaliforniaCAThousand Oaks, CA26445046http://www.amgen.jobs/xml/26445046/jobUSAThousand OaksAuto req 13249BR Job Posting Title Grad Intern - Global Health Economics Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Global Health Economics department at our Thousand Oaks, CA headquarters is looking for a graduate student interested in a 10 – 12 week internship. The intern will be responsible for the following: 1) Manage development of economic section of Epogen and Aranesp Dossiers, 2) Update, interpret and assist with the drafting of an Economic Literature Review, 3) Summarize internal Amgen Economic Models for economic sections 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 obtaining a PharmD Degree - 3rd year of study and up or obtaining a PhD in health economics, health policy, or health services research - 2nd year of study an up. 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 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 • A Master in Public Heath and some form of clinical experience in the medical fieldUnited StatesAmgen2012-02-09 23:45:25CaliforniaCAThousand Oaks, CA26445035http://www.amgen.jobs/xml/26445035/jobUSAThousand OaksAuto req 13251BR Job Posting Title Grad Intern - Global Health Economics Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Global Health Economics department at our Thousand Oaks, CA headquarters is looking for a graduate student interested in a 10 – 12 week internship. The intern will be responsible for the following: • Under the guidance of the hiring manager, write up a mini-RPP/SAP • Build an analytical dataset • Generate data tables and figures • Present analyses results to GHE XGEVA team/GHE Hema/Onc team • Draft an abstract based on the results 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 obtaining a Masters of Science, or PharmD, or PhD Currently majoring in statisics, biostatistics, health economics or health services research Minimum 1 year experience of programming with SAS or STATA 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 year of study at the time the internship begins • 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 • Good understanding of retrospective databases analysis principles/techniquesUnited StatesAmgen2012-02-09 23:44:31CaliforniaCAThousand Oaks, CA26445004http://www.amgen.jobs/xml/26445004/jobUSAThousand OaksAuto req 13252BR Job Posting Title Grad Intern - Global Health Economics Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Global Health Economics department at our Thousand Oaks, CA headquarters is looking for a graduate student interested in a 10 – 12 week internship. The intern will be responsible for the following: 1) Create a slide deck that summarizes the available PRO evidence from the existing trials (including relevant publications) 2. Review and create a summary slide deck for the PRO analysis from the 2 new trials 3. Compare the information across trials (including working with biostats to conduct new analyses) 4. Create an abstract and presentation on Prolia PROs 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 obtaining a Masters in Health Services Research, Health Outcomes, Health Economics or related field. Must have experience in PROs. 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 year of study at the time the internship begins • 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 • PhD student in Health Services Research, Health Outcomes, Health Economics or related field. • Must have experience in PROs.United StatesAmgen2012-02-09 23:45:26CaliforniaCAThousand Oaks, CA26445036http://www.amgen.jobs/xml/26445036/jobUSAThousand OaksAuto req 13589BR Job Posting Title Grad Intern - Global Health Economics Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Global Health Economics department at our Thousand Oaks, CA headquarters is looking for a graduate student interested in a 10 – 12 week internship. The intern will be responsible for participating in a number of claim database analyses of patients with RA. Specific objectives would include ascertaining the rates of dose increases seen with certain treatments and comparing RA treatment costs per and post formulary changes. 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 obtaining graduate degree in economics, public health, or a Pharm D and have completed their undergraduate degree in a related field. 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 year of study at the time the internship begins • 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 • An understanding of claim analyses or economic modeling is desirable, but not mandatory.United StatesAmgen2012-02-09 23:46:12CaliforniaCAThousand Oaks, CA26445054http://www.amgen.jobs/xml/26445054/jobUSAThousand OaksAuto req 13870BR Job Posting Title Clinical Research Medical Director - Oncology Therapeutic Area 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 - 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) 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 issuesUnited StatesAmgen2012-02-09 23:44:48CaliforniaCAThousand Oaks, CA26445010http://www.amgen.jobs/xml/26445010/jobUSAThousand OaksAuto req 13442BR Job Posting Title Grad Intern - Clinical Immunology Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgens Clinical Immunology department at our Thousand Oaks headquarters is looking for a graduate student interested in a 10 12 week internship to support a research project that involves development and comparison of different assay formats used to detect anti-drug neutralizing antibodies to biological therapeutics. A summer intern dedicated to this project will greatly enhance the groups ability to generate these comparative data that have an important application in performing immunogenicity testing for biological therapeutics. The following will be provided to the intern during the summer internship: Appropriate training in order to have a thorough understanding of the scope of the project Appropriate regulatory training The intern will learn how to design non cell-based anti-drug neutralizing antibody assay formats for 1-3 products 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 obtaining a Graduate degree in Life Sciences 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 Knowledge of enzyme-linked immunosorbent assays (ELISAs) or equivalentUnited StatesAmgen2012-01-30 23:42:32CaliforniaCAThousand Oaks, CA26200951http://www.amgen.jobs/xml/26200951/jobUSAThousand OaksAuto req 8943BR Job Posting Title Engineer - Device Engineering 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. 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. This position is should also have the following experiences: 1. Background in engineering and commercialization process with injectable devices, and experience in or knowledge of processes for the production of novel formulation is also desired. 2. Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. 3. Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. 4. Industrial 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). 5. Experience or knowledge in the process development of combination product aspects of these systems for macromolecules is desired. 6. General knowledge of regulatory, marketing, business development and quality aspects of drug delivery device/system development is also desired. 7. Experience with partnerships between pharmaceutical and drug delivery companies. 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 Advanced 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 Demonstrated Competencies/Skills: 1) Independent thinker with demonstrated skills working in teams or leading project teams 2) Strong Interpersonal and communication skillsUnited StatesAmgen2012-01-11 20:36:47CaliforniaCAThousand Oaks, CA25834391http://www.amgen.jobs/xml/25834391/jobUSAThousand OaksAuto req 13541BR Job Posting Title Sr Associate IS Analyst 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. 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 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 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. - 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: - Information Architecture - Portals & Collaboration Tools - Iterative Development - Formalized Requirements Gathering - Experience with LDAP, VPNs and ASP services also a plus - Development of policies, SOPs and associated documents - Internet protocols including: TCP/IP and HTTP and Web technologies.United StatesAmgen2012-02-08 02:39:37CaliforniaCAThousand Oaks, CA26389652http://www.amgen.jobs/xml/26389652/jobUSAThousand OaksAuto req 13672BR Job Posting Title Grad Intern - Global Value & Access Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Global Value & Access – Global Pricing and Payer Planning department at our Thousand Oaks, CA headquarters is looking for a graduate student interested in a 10 – 12 week internship. The intern will work with a project team within Global Pricing and Payer Planning (GP3). GP3 works to understand the requirements put forward by payers across the globe to ensure a positive decision with regard to coverage, reimbursement, and payment for Amgen products. Intern will complete a payer strategic analysis for South Korea and Taiwan using both secondary and primary research. Output from this project will provide insights regarding the pricing & reimbursement system and issues of two key emerging markets countries. Intern will use existing research to gain a fundamental understanding of the health care system and market access hurdles in each country. Working with Global Payer Leads and vendor, intern will identify both country and product-specific knowledge gaps and key issues to address. Review new secondary research findings to develop interview stimulus materials for primary research. Analyze secondary and primary research findings with vendor and Global Payer Leads into key learning and implications for successful market access, with specific insights for select products, such as AMG 785 and 145. 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 have completed an undergraduate degree in life sciences or humanities and in the process of obtaining a graduate degree (e.g. , MPH or MBA) pharmacy or medical school program. 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 at the time of application; • 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 • Demonstrated interest in healthcare • Excellent written skills with the ability to accurately summarize and organize market healthcare data and incorporate the data into an assessment of current data gaps which will drive approach to this project. • Project management skills • Computer literacy • Interpersonal skills • Basic understanding of healthcare system and its funding • Analytical skills • Ability to draw conclusions and/or hypothesis from analyses • Ability to communicate concisely and clearly • Understanding of reimbursement/payer issues • Experience in Asian marketsUnited StatesAmgen2012-02-08 20:04:07CaliforniaCAThousand Oaks, CA26410344http://www.amgen.jobs/xml/26410344/jobUSAThousand OaksAuto req 13633BR Job Posting Title Grad Intern - Drug Product Development Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Drug Product Development department at our Thousand Oaks headquarters is looking for an graduate student interested in a 10 – 12 week internship to be involved in expanding our understanding of the mechanism of glass dissolution and delamination and to map the formulation and container factors that lead to glass degradation. The existing knowledge in this area will be leveraged and the intern will • Use HPLC-based assays to assess the effect of formulation conditions on container interactions. During the internship the intern will be working closely with the scientists/ subject matter experts in the group. The intern will have ample opportunities to work with cutting edge analytical and surface techniques to explore the phenomenon of glass dissolution/ delamination in specific, as well develop an in-depth understanding of general protein stability considerations as it relates to the formulation container interactions. In addition to the technical training, this will also enable the intern a “snapshot” of what it means to work in a professional setting and the associated experiences that comes with it including but not limited to teamwork, timeline management, and effective communication. 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 In the process of pursuing a masters or a PhD degree in biochemistry/pharmaceutical science/chemical engineering/life sciences/chemistry. 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 by the time the internship begins; • 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 • A working knowledge of proteins with an understanding of protein chemistry, protein-surface interactions and stability is preferable. • Applicants with knowledge of protein or small molecule techniques (chromatographic assays) will also be preferred.United StatesAmgen2012-02-08 20:05:51CaliforniaCAThousand Oaks, CA26410417http://www.amgen.jobs/xml/26410417/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 or clinical experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies OR • Master’s degree and 10 years of regulatory affairs or clinical experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies OR • Bachelor’s degree and 12 years of regulatory affairs or clinical 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 teamsUnited StatesAmgen2012-02-11 19:45:48CaliforniaCAThousand Oaks, CA26476662http://www.amgen.jobs/xml/26476662/jobUSAThousand OaksAuto req 13909BR Job Posting Title Biosimilars Regulatory Senior Manager 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: The Biosimilars Regulatory Senior Manager role is located at Amgen's headquarters in Thousand Oaks, CA. • Prepare scientific and regulatory documents that comply with global regulatory standards to support submissions for development, approval, and maintenance of Amgen biosimilar products • Manage contract and ad hoc global regulatory writers (CMC, clinical, and non-clinical) • Ensure that high-quality regulatory documents are delivered according to approved timelines Key Activities: ? Independently manage preparation of scientific and regulatory documents, including briefing books, analytical packages, Investigator Brochures, clinical trial applications, marketing applications, Risk Management Plans, responses to regulatory questions, etc. ? Lead writing teams in the timely development of required regulatory documents ? Identify, assess, and oversee vendor and/or partner regulatory writers, individual contractors, freelance, and/or temporary writers ? Review, edit, and approve regulatory documents prepared by external resources on an ongoing basis to ensure delivery of documents according to approved timelines ? Train vendors, partners, individual contractors, temporary writers and subject matter experts with the development of specific sections of regulatory documents utilizing established templates, processes, and technology according to defined timelines ? Manage support by internal regulatory writers, publishing, and others as required ? Ensure that regulatory writers assigned to assist the Biosimilars function are informed and familiar with the unique requirements and commonalities of regulatory documentation to support the biosimilars product portfolio as required ? Review regulatory documents and ensure sign-off by management approvers according to timelines ? Establish and monitor editing and quality control processes ? Keep abreast of professional information and technology ? Provide expertise and guidance on document design and principles of good medical writing to the Biosimilars function ? Establish writing project priorities ? Escalate document preparation issues, progress, and metrics to the Biosimilars function ? Collaborate with the project management group to ensure timelines are appropriately developed, communicated, and followed by submission teams ? Proactively plan with the Biosimilars team to ensure that requirements for writing resources to achieve the biosimilar goals and objectives are identified in a timely manner and are made available within budgetary constraints and approved plans ? Share insights on biosimilar regulatory requirements with colleagues 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 AND 2 years of direct managerial and/or leadership experience Preferred Qualifications • Degree in Life Sciences or related field • Experience in the pharmaceutical/ biotechnology industry • Regulatory submissions experience • Regulatory knowledge of global regulations • Working with policies, procedures, and SOPs • Understanding of drug development • Experience in writing clinical and regulatory documents for all phases of regulatory submissions (early development, briefing books, CTAs to MAs) Knowledge and Skills • Advanced knowledge of scientific, technical and regulatory writing and editing • Advanced knowledge of related regulatory and industry considerations, compliance issues, and/or scientific discovery • Understanding and application of principles, concepts, theories and standards of scientific and technical fields • Knowledge of management skills and supervising the work of others • Experienced in managing and facilitating teams and projects in a global, regulated environment • Ability to understand and communicate scientific and clinical information • Ability to anticipate and prevent potential issues • Strong Microsoft Office applications skills • Ability to engage different personalities • Mentoring, training and directing othersUnited StatesAmgen2012-02-11 19:44:49CaliforniaCAThousand Oaks, CA26476649http://www.amgen.jobs/xml/26476649/jobUSAThousand OaksAuto req 12798BR Job Posting Title Sr Associate - Cell Culture Career Category Process Development Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The successful candidate will work as part of a team within the Cell Sciences & Technology department dedicated to developing world-class upstream processes for the manufacture of human therapeutics from mammalian cells. Specifically, this will involve (1) screening mammalian cell lines for desirable production characteristics, (2) executing cell culture experiments at bench and bioreactor scale (50mL - 50L) designed to increase product yields and control product quality, (3) continuously improving cell culture systems and techniques, (4) producing preclinical material for development work in collaborative groups, (5) providing technical support during process transfer and execution of pilot and clinical manufacturing runs, (6) presenting data at team meetings, (7) documenting experiments and drafting technical reports. Basic Qualifications Master’s degree OR Bachelor’s degree & 2 years of scientific experience Preferred Qualifications Master's degree in Bioengineering, Biotechnology, Life Sciences, or Chemical Engineering; or Bachelor's degree in aforementioned discipline with 2+ years of experience in bio/pharma industry. Candidates must be highly motivated and possess outstanding oral and written communication skills. Candidate must also have a capacity to work effectively with diverse team members toward common project goals, and an ability to think creatively as well as critically. Demonstrated ability to apply science-based methodology to cell-culture process development is preferred.United StatesAmgen2012-02-17 19:39:30CaliforniaCAThousand Oaks, CA26597031http://www.amgen.jobs/xml/26597031/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.United StatesAmgen2012-02-17 19:41:02CaliforniaCAThousand Oaks, CA26597058http://www.amgen.jobs/xml/26597058/jobUSAThousand OaksAuto req 13953BR Job Posting Title Senior Bioanalytical Project Manager Career Category Project Management 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 looking for a Bioanalytical Project Manager to join our Clinical Immunology group. This role: • Provides advanced project level management of the technical transfer, validation and/or study performance of bioanalytical methods at Technical Service Providers (TSP’s) to evaluate scientific integrity and adherence to the protocol/plan/contracts and applicable regulations • Independently conceives, designs, implements, and/or executes specific scientific experiments which contribute to the successful completion of goals and/or projects • Introduces new or advanced technologies and/or concepts • Develops and/or implements novel protocols to address specific issues and/or troubleshoots and improves currently existing assays towards being more sensitive, transferable, and high-throughput • Provides advanced data analysis and interpretation, assesses impact of the data on the project, and makes recommendations • Functional level management of Supplier Performance and Relationships: Measure, analyze, and manage the performance of vendors with attention toward opportunities to cut costs, alleviate risks, and drive continuous improvement • Guides the execution of major supplier management business processes and/or projects within the department • Leads teams that contribute to the achievement of department/project/function objectives • Initiates productive collaborations outside of the department or company. • Contributes to and (co) authors scientific and/or operational documents such as posters, journal publications, technical reports, etc. 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 for this role include: Doctorate degree in Life Sciences or related field with: • A minimum of 2 years of relevant laboratory and/or management experience Or, Master’s degree in Life Sciences, Business or related field with Bachelors degree in Life Sciences or related field and • A minimum of 7 years of relevant experience Or, Bachelor’s degree/Medical Technologist in Life Sciences or related field with • A minimum of 10 years of relevant experience • Project management tools/techniques (PMBOK), PMP certification desired • Drug development process • Biology, immunology and biochemistry • Good Laboratory Practices and Good Clinical Practices (GLP/GCP) • CRO/TSP standard practices and management/monitoring tools/techniques • Scientific method and biostatistics • Supplier Relationship and Performance Management tools/techniques • Cross-functional and cross-site team management tools/techniques • Process improvement, mapping and alignment; Six Sigma, LEAN or similar training desired • Technical writing and document control/change control systems • Bioanalytical methods (including large molecule assays and immunoassay ± bioassay ± cytometry) • Method validation, technology transfer, and method performance monitoring/trending best practices • Common and specialized computer software application proficiency and adaptability (eg, MS Office suite, MS Project, MS Visio, WebEx, LIMS, JMP et.al) • Timeline and expectation management • Ability to make decisions effectively as an individual or through facilitation of a group • Independent and critical thinking • Advanced meeting coordination and facilitation skills including use of technologies (eg, teleconference, videoconference, webinar) • Skilled in managing multiple responsibilities, priorities, tasks and projects simultaneously • Strong interpersonal skills, negotiation skills, active listening, and relationship management skills including interfacing effectively across levels and organizations. • Professional business verbal and written communication skills • Problem solving, root cause analysis and innovation • Detail oriented and highly organized • Initiative and motivation • Ability to train and manage people effectively in a matrixed environmentUnited StatesAmgen2012-02-17 19:38:27CaliforniaCAThousand Oaks, CA26597017http://www.amgen.jobs/xml/26597017/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 OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications A successful candidate in this role should: • 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 teamUnited StatesAmgen2012-02-17 19:39:09CaliforniaCAThousand Oaks, CA26597026http://www.amgen.jobs/xml/26597026/jobUSAThousand OaksAuto req 13902BR Job Posting Title Clinical Research Sr Medical Scientist - Inflammation Career Category Clinical Development 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 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 issuesUnited StatesAmgen2012-02-10 18:15:59CaliforniaCAThousand Oaks, CA26456561http://www.amgen.jobs/xml/26456561/jobUSAThousand OaksAuto req 13904BR Job Posting Title Sr Project Mgr - Quality Risk Management Career Category Quality Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description As part of the Quality Systems group this position will lead the Quality Risk Management and Operational Excellence program (e.g. risk assessment and continuous business improvement). This position will be responsible for partner with contract manufacturing and supplier quality. Under minimal direction, this position will be responsible for managing Quality System business processes supporting the External Quality organization and their Operations counterparts. Focus on leading initiatives with significant complexity and act as a strategic business partner to a wide range of External Quality clients in the areas of Quality System Maturity, Risk Management, and Operational Excellence. Utilize leadership qualities and to successfully influence outcomes, communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metrics generation and reporting. Up to 25% travel may be required depending on project needs domestically and international Key Responsibilities Leadership of multi-faceted, cross-functional teams Effective scoping including translating strategy into actionable objectives Effectively leverage Operational Excellence methods to deliver process efficiency and effectiveness improvements within agreed scope, schedule and budget Utilize appropriate tools to drive the management of quality risk Utilize basic statistical analysis tools and project planning techniques to communicate timelines and report on progress Interface with stakeholders and sponsors on project progress, issues, and plans for 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 Masters degree in physical or life sciences, engineering or business Experience in project management, process improvement, or performance management consulting 2 years independently leading cross-functional project teams 5 years of functional experience in biotechnology, pharmaceutical development and/or medical device Experience in advanced analytical process methods and tools such as Lean Six Sigma, KT Analysis Financial acumen to support business case generation and cost/benefit analyses Executive communication experience to include written and oral presentations Knowledge of portfolio management methods Demonstrated ability to navigate through ambiguity and provide a structured problem solving approach Organizational savvy and presence to build effective relationships across functions Formal or informal experience supervising, mentoring or coaching staff Track record of building or participating as a member of high performing teams Proficiency in MS Office tools including Excel, PowerPoint, Word, MS Project and VisioUnited StatesAmgen2012-02-10 18:16:51CaliforniaCAThousand Oaks, CA26456579http://www.amgen.jobs/xml/26456579/jobUSAThousand OaksAuto req 13890BR Job Posting Title Principal Scientist - PKDM Career Category Clinical 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.United StatesAmgen2012-02-10 18:17:40CaliforniaCAThousand Oaks, CA26456588http://www.amgen.jobs/xml/26456588/jobUSAThousand OaksAuto req 13113BR Job Posting Title Sr Project Mgr - Operation Program Management Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description As part of the Operations Program Management Organization, the position, under minimal direction, will be responsible for establishing and leading high priority, cross-functional programs within the Operations organization. By leading initiatives with significant complexity the Senior Project Manager will act as a strategic business partner to a wide range of Operations clients to deliver programs with high quality results and business impact. Utilize extensive leadership and influencing qualities to successfully deliver program objectives, communicate at all levels of the organization, facilitate development of solutions to critical business issues, and effectively define program goals. Up to 5% domestic or international travel may be required depending on program needs. Key Responsibilities Single accountable party for defining, planning, orchestrating, and delivering critical global, cross-function programs Ensures end results are of the highest caliber with a clearly articulated scope and quantifiable business benefit Directs large-scale, complex programs often involving multiple internal and external stakeholders, and business partners Directly manages all aspects of the program life cycle and works with functional business partners to oversee all critical program phases Rigorously manages scope to ensure commitments are achieved within agreed upon time, cost, and quality parameters Generates and/or validates financial forecasts and provides on-going reconciliation of resources and other related program expenditures as needed Effectively interacts with senior level audiences Lead a diverse and distributed team Serves as a central Point of Contact for routinely briefing key stakeholders on different aspects of assigned initiatives Represents the Program in various governance and inter-department forums – works with Subject Matter Experts to gather relevant data for presentation Chairs program core team and Advisory Committee meetings to review progress with key stakeholders Develops communication plans and interfaces to execute on responsibilities 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 Masters degree in physical or life sciences, engineering or business Experience in project management, process improvement, or performance management consulting 4 years independently leading cross-functional projects or programs 5 years of functional experience in biotechnology, pharmaceutical development and/or manufacturing Certified Project Management Professional (PMP) Proven ability to quickly earn the trust of sponsors and key stakeholders, mobilize and motivate teams, set direction and approach, resolve conflict, deliver tough messages with grace, execute with limited information and varying levels of ambiguity Ability to communicate at all levels with clarity and precision both written and verbally Solid influencing skills – experience with stakeholder management Track record of building or participating as a member of high performing teams and organizations Organizational savvy and presence to build effective relationships across functions Formal or informal experience supervising, mentoring or coaching staff Ability to navigate a highly matrixed organization effectively Demonstrated ability to navigate through ambiguity and provide a structured problem solving approach Knowledge and experience with portfolio management methods Sound business and technical acumen Ability to prioritize workload in accordance with business strategy and objectivesUnited StatesAmgen2011-12-09 20:24:22CaliforniaCAThousand Oaks, CA25276904http://www.amgen.jobs/xml/25276904/jobUSAThousand OaksAuto req 14000BR Job Posting Title Research Operations Sr Mgr - Small Molecule Process and Product Development Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen Small Molecule Process and Product Development (SMP&PD) is a science and technology-based organization which develops manufacturing processes, formulations, analytical methods and innovative solutions for Amgen's clinical and commercial small and large molecule therapeutics. The Research Operations Sr. Manager reports to the Director, SMP&PD Business Operations, works closely with the CMC Teams, Business Operations team, the SMP&PD Senior Leadership Team, and key internal/external stakeholders to deliver impact through superior business operations expertise. The Sr. Manager ensures that all deliverables are achieved through excellent organization, communications, business analysis and leadership skills. The Sr. Manager also lead and/or participate the development of SMP&PD metrics and dashboard reporting, and cross-functional initiatives to improve processes, tools and expand new capabilities. The Sr. Manager may have supervisory responsibility and/or mentor junior staff. The Sr. Manager in Business Operations contributes in the following capacities: CMC Project Management: Lead project business and operational deliverables during small molecule process and product development. The Sr. Manager ensures that all aspects of small molecule commercialization are carefully considered cross-functionally within SMP&PD, Operations and companywide to effectively support advancing Amgen pipeline. Clinical Contract Manufacturing Project Management: Lead project management deliverables for GMP/non-GMP/technology outsourcing projects for DS and DP engaging domestic, international and emerging markets suppliers, to deliver product or technology and ensure meeting compliance, speed, quality and cost targets. Develop and manage strong Amgen internal partnerships and external relationship with contractors. 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 • MBA or Advanced degree in Sciences or Engineering • 5 years+ of experience in the biotechnology/ pharmaceutical industry in Process Development, Manufacturing or Quality • 2 yr + direct business operations experience in the above fields, including the ability to identify and execute initiatives, manage multiple projects, prioritize project resources, and ensure project effectiveness and efficiency • 2 yr+ direct contract manufacturing business experience in emerging markets (China, India, Russia etc.) in either buy/sell role • Strong business acumen and analytical skills • Experience with business process development, continuous improvement and performance management experience COMPETENCIES/SKILLS • Experience with pharmaceutical product commercialization and life cycle management to recognize strategic implications of complex process and product development activities, and manage the development process effectively and cross-functionally • Excellent verbal and written communication skills to effectively communicate vertically and horizontally through multiple channels • Strong leadership skills to influence and leverage contact network to motivate diverse teams and enable cross-functional collaboration without direct authority • Excellent interpersonal skills to quickly build trust and rapport with internal and external stakeholders • Navigate through 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 • Proficient user of Amgen platform systems, such as MS Excel, Power Point, SharePoint, EDM etc.United StatesAmgen2012-02-18 20:20:45CaliforniaCAThousand Oaks, CA26613554http://www.amgen.jobs/xml/26613554/jobUSAThousand OaksAuto req 14002BR Job Posting Title Principal Business Analyst - Small Molecule Process and Product Development Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen Small Molecule Process and Product Development (SMP&PD) is a science and technology-based organization which develops manufacturing processes, formulations, analytical methods and innovative solutions for Amgen's clinical and commercial small and large molecule therapeutics. The Principal Business Analyst takes a leadership role in business analysis, and reports to the Director, SMP&PD Business Operations, working closely with the SMP&PD Senior Leadership Team, Business Operations team and CMC teams, and key internal/external stakeholders to deliver impact through superior business analysis expertise. The Principal Business Analyst ensures that all deliverables are achieved through excellent analysis, planning and communication. The Principal Business Analyst coaches and mentors other members in Business Operations Team to develop business analysis core competency within the group. The Principal Business Analyst contributes in the following capacities: Business Analysis and Strategic Planning • Utilize strong business analysis skills to collect, organize, mine, digest, synthesize and present relevant business information and intelligence, particularly on internal/external resources including FTE, expense, facility and equipment, to enable sound decision-making • Develop and maintain the process, systems and tools for SMP&PD resource modeling, forecasting, and monitoring • Actively contribute to strategic planning, scenario analysis, and project prioritization to support organic and inorganic portfolio growth and optimize internal and external network resource utilization • Facilitate cross-functional resource alignment through working closely with key stakeholders Operational Excellence • Lead and/or participate the development and reporting of SMP&PD key performance index (KPI) and performance targets, including productivity measures • Lead and/or participate cross-functional productivity initiatives to improve business processes, tools and expand new capabilities 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 and/or Advanced degree in Sciences or Engineering • 5 yr + experience in the biotechnology/pharmaceutical industry in one or a combination of the following fields: R&D, Process Development, Manufacturing, Quality, Program Management, Strategic Planning, Supply Chain, Engineering, Regulatory Affairs, Clinical Development, Finance or equivalent fields • 2 yr + direct business analysis, strategic planning and/or performance improvement/management experience • The following experience/combined experiences are strong pluses: management consulting, finance, investment banking, project management in pharmaceutical process/product development and life cycle management, domestic/emergent market contract manufacturing, PREFERRED COMPETENCIES/SKILLS • Strategic planner and thinker who considers complex business parameters, their interdependences, timing/duration to provide scenarios to optimize business performance • Independent problem solver who could leverage experiences, models, benchmarks and other direct/indirect business information to quickly develop supportive analysis and insightful recommendations • Strong business acumen and analysis skills, including excellent skills in MS Excel, SharePoint and other business planning tools and process, e.g. TM-1, SAP, database etc. • Excellent verbal and written communication skills to effectively communicate vertically and horizontally through multiple channels • Ability to influence, motivate and develop team without direct authority • Strong Amgen operations commercialization knowledge, especially in small molecule arena • Business process development, continuous improvement, operational excellence and performance management skillsUnited StatesAmgen2012-02-18 20:21:00CaliforniaCAThousand Oaks, CA26613555http://www.amgen.jobs/xml/26613555/jobUSAThousand OaksAuto req 14021BR Job Posting Title Associate Pilot Plant Career Category Research Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This position will be responsible for executing operations in a large-scale pilot plant, including chromatography, filtration, centrifugation, UF/DF and buffer preparation and equipment set-up. Additional activities will include defining and documenting operational practices, ensuring documentation accurately reflects operations performed, and implementing area improvements. This position will participate in planning meetings and spend a significant amount of time performing ‘hands-on’ work on the plant floor executing runs, experiments and characterization efforts. The non-GMP pilot plant performs appropriately-scaled operations to develop and demonstrate production processes and to produce pre-clinical bulk material. As such, the area performs downstream activities for multiple mammalian and microbial products, and frequently pilots novel process operations, equipment or techniques. The environment is challenging and ever-changing, with varying degrees of process definition. Candidates should possess a basic knowledge of downstream operations (listed above), as well as a general knowledge of associated analytical methods, CIP/COP, and SIP. 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 biology, chemistry, biochemistry, chemical engineering or other scientific field Hands-on purification or other pharmaceutical experience Energetic and technically-minded individuals Strong interpersonal and organizational skills Ability to learn new systems, applications, and various purification techniques Able to work effectively in team and/or project environments, possess strong math and computer skills, and possess the ability to apply science-based thinking to practical applicationsUnited StatesAmgen2012-02-18 20:20:07CaliforniaCAThousand Oaks, CA26613551http://www.amgen.jobs/xml/26613551/jobUSAThousand OaksAuto req 12787BR Job Posting Title Principal Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Working in a group of chemical engineers, this position provides technical project oversight for the Process Engineering discipline in development of chemical synthesis. The qualified candidate will be well versed in chemical engineering fundamentals, process development, scale up, and tech transfer. Operating in a matrixed environment with cross-functional teams, the successful candidate will develop and support the lifecycle management of new chemical processes. In general, the candidate will be accountable for: a) Process Development: developing mid to late stage chemical processes; designing and executing experimental plans; process simulation; and process characterization. b) Expert Analysis: including process and technology review analysis and improvement identification; assessment of applicable new technologies and techniques. c) Planning and Execution of Projects: including process design; positioning processes for commercialization; participating/authoring regulatory documents; life cycle management. The primary area of focus for this position is pharmaceutical drug substance synthesis (e.g. chemical reaction, mixing, crystallization, drying, etc.). For these areas of focus, the engineer is expected to have a solid foundation in key chemical engineering fundamentals and a working knowledge of associated unit operations. Success in this role is dependent upon the individual's ability to effectively communicate and collaborate with team members, train and mentor junior staff members, and to diligently focus on phase appropriate development. The applicant is accountable for establishing and applying the best available technical solutions for development. This would include evaluation of new technologies, analysis of alternative technical solutions, applications of process modeling tools, and contributing to the communication and teaching of best practices across the engineering group as well as with our technology teams. The applicant may be expected to contribute to increasing the effectiveness and efficiency of the department by contributing toward improvements of guidelines, procedures, practices, standards and cross-functional business interfaces and processes. The candidate should have a collaborative mindset for sharing insights and improvements, strong communication skills, and a willingness to actively participate in design reviews across the project portfolio. 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 We would like to have a candidate with a BS/MS in Chemical Engineering with a minimum of 6 years pharmaceutical technology experience, with demonstrated success involving process design, process performance analysis, and process development. The candidate must have demonstrated development project management and/or execution experience, with proven knowledge of cGMP and regulatory compliance requirements. The position requires technical leadership, collaboration, and sound business value based prioritization and problem solving skills. A preferred candidate would have a Ph.D. in Chemical Engineering with a minimum of 4 years pharmaceutical technology experience. Industry field recognition and demonstrated contributions.United StatesAmgen2012-02-15 21:59:20CaliforniaCAThousand Oaks, CA26547270http://www.amgen.jobs/xml/26547270/jobUSAThousand OaksAuto req 13959BR Job Posting Title Category Senior Manager 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 skills -Demonstrated success with strategically sourcing services that support a biopharma research organizationUnited StatesAmgen2012-02-14 19:52:50CaliforniaCAThousand Oaks, CA26520426http://www.amgen.jobs/xml/26520426/jobUSAThousand OaksAuto req 13910BR 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 Subject Matter Expert: Basic and Clinical Research 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 •5 years post doctoral experience in academic or industry setting •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 Preferred Qualifications •Board certified in Oncology and/or Malignant Hematology •PhD or a strong basic science or clinical research background in academics or pharma •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 plus.United StatesAmgen2012-02-15 21:59:43CaliforniaCAThousand Oaks, CA26547283http://www.amgen.jobs/xml/26547283/jobUSAThousand OaksAuto req 13848BR Job Posting Title Health Economics Sr Manager Career Category Health Economics Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description • Plan and develop evidence-based economic models aligned with global strategy and tailored to local payer needs to assess clinical practice, burden of illness, budget impact and cost-effectiveness in relevant settings. • Develop timely recommendations regarding critical model data requirements to be collected in clinical trial and evidence generation activities and influence the evolving value strategy. • Support external validation of models, develop technical reports, annotate and package models for affiliates, in close collaboration with cross-functional business partners and external experts. • Lead the development of economic value propositions using leading edge techniques across the entire product life cycle. • Lead cross-functional economic modeling teams. • Project management of project deliverables against timelines, budget and overall project prioritization. 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 Preferred Qualifications • Advanced degree in Health Economics and/or a quantitative discipline such as statistics, econometrics or epidemiology. • 5+ years industry experience designing cost-effectiveness, cost of illness and budget impact models used in strategic healthcare decision making. • Proven hands-on experience using Excel, Visual Basic, and/or TreeAge Pro. Experience using SAS, WinBUGS and other software for statistical analyses will be an advantage. • Solid project management skills including the ability to steer and drive the team towards objectives and hold team members accountable as well as highly motivated.United StatesAmgen2012-02-15 22:00:04CaliforniaCAThousand Oaks, CA26547291http://www.amgen.jobs/xml/26547291/jobUSAThousand OaksAuto req 13905BR Job Posting Title Global Safety Senior Medical Scientist - Bone Therapeutic Area Career Category Safety Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role -- which resides within the Global Safety Bone Therapeutic Area -- 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 Current registered medical license Board certified or Board eligible Accredited fellowship or clinical experience Clinical experience, including training Drug safety experienceUnited StatesAmgen2012-02-15 22:00:08CaliforniaCAThousand Oaks, CA26547293http://www.amgen.jobs/xml/26547293/jobUSAThousand OaksAuto req 13741BR Job Posting Title Undergrad Intern - Drug Substance Development Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Drug Substance Development department at our Thousand Oaks headquarters is looking for an undergraduate student interested in a 10 – 12 week internship to help develop novel technologies to be used to enable the real time monitoring of intracellular pathways and cell functions in our biotherapeutic production cell lines. This info will be used for optimization of cell line and process development. The intern will learn the basic molecular and cell biology concept and techniques and the experiment design as well as problem solving and troubleshooting skills. The intern will also get a chance to learn aspects of the drug development process in biotech industry. 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 obtaining an Undergrad degree with major in biology, microbiology, biotechnology, chemical engineering 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 at the time of application; • 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 • Familiarity with molecular biology and/or mammalian cell culture advantageous. • Willing to learn and interest in the biotech industry. • Previous experience with growth and maintenance of mammalian cell lines, transient transfection, cryo preservation/cell banking. • Use of E.coli for generation of plasmid DNA, exposure to modern molecular techniques for DNA cloning.United StatesAmgen2012-02-14 20:00:04CaliforniaCAThousand Oaks, CA26520609http://www.amgen.jobs/xml/26520609/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 *Ph.D in life sciences and 4+ years of industry experience. *Experience in the development and application of biomarkers for the development of cardiovascular therapeutics (e.g. dyslipidemia, atherosclerosis). 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, 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.United StatesAmgen2012-02-15 22:00:25CaliforniaCAThousand Oaks, CA26547305http://www.amgen.jobs/xml/26547305/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 •Residency in Internal Medicine or related discipline •Excellent oral and written communication skills •Excellent interpersonal skills •Experience in basic research and clinical trial methodology •Experience in early clinical trials •Experience interacting with IRBs, and Ethics Committees •Solid understanding of GCP and Healthcare Compliance •Publication track record •Ability to lead, manage and motivate teams Preferred Qualifications •Subspecialty fellowship training in Clinical Pharmacology, or an Internal Medicine subspecialty, with a background in translational medicine •Ph.D. in biological science •Experience in serving on an IRB or Ethics Committee •Board certification or eligibleUnited StatesAmgen2012-02-14 20:00:48CaliforniaCAThousand Oaks, CA26520634http://www.amgen.jobs/xml/26520634/jobUSAThousand OaksAuto req 13844BR Job Posting Title Global Safety Senior Manager - Medical Sciences Career Category Safety Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Group Purpose: The Medical Sciences group provides safety input to early stage teams according to product, input to documents which communicate risk, develops risk assessment and monitoring strategies and assists in analysis and communication of safety data. Job Summary: • Support clinical study execution throughout the provision of safety elements within protocols, supporting documents and study reports • Support products overall safety surveillance by ensuring effective study level execution • Collaborate in executing the safety surveillance strategy for product candidates/approved products • Coordinate appropriate scientific and medical safety input into clinical development programs and provide a focal point for respective products safety information and awareness • Support the Global Safety Officer (GSO) by communicating safety profiles to internal Amgen constituencies • To provide safety input to early stage teams according to product. This role will be located at Amgen's headquarters in Thousand Oaks, CA. Key Activities: ? Responsible for the representation of safety in GDT, GST,, GRT and PSRM meetings ? Contribute to the escalation and evaluation of issues ? Execute trials elements of issue management plans ? Contribute to the escalation and evaluation of issues ? Support development of strategic plans for safety differentiation ? Develop consistent standards and process for CRO safety functioning ? Develop and maintain trials safety related processes ? Review and provide program level input to study concept documents, protocols, data management plans and CRFs ? Support alignment harmonization of product safety content in documents, globally ? Review and approve Investigator Meeting safety presentations ? Contribute to the development and maintenance of product safety profiles ? Contribute to the assembly of clinical trial data for publications ? Participate in internal Safety Data Review Teams ? Draft and support implementation and evaluation of Risk Assessment and Management Plans ? Support DMC liaison and recommendations ? Develop safety presentations for quarterly safety reviews; contribute to recommendations closure ? Review and CSR preliminary safety analysis and interpretation ? Facilitate consistency within individual products ? Contribute to response strategy and drafting for safety inquiries relating to studies ? Contribute to ensuring inspection readiness ? Develop and maintain policies, guidelines and SOPs ? Participate in TA meetings; support the “singular voice” on global safety issues 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 Knowledge and Skills ? Ability to effectively represent ideas and clinical data ? Clinical knowledge of therapeutic area patient population and drugs ? Interpretation of aggregate safety data ? Expert knowledge of the product development life cycle and clinical trial initiation/conduct/reporting ? Mastery of safety data capture, representation and interpretation ? Formal Management experience and knowledge ? Expert knowledge of the Global safety environment, international regulations and guidance documentsUnited StatesAmgen2012-02-15 22:00:48CaliforniaCAThousand Oaks, CA26547323http://www.amgen.jobs/xml/26547323/jobUSAThousand OaksAuto req 13939BR Job Posting Title Undergrad Intern - Corporate Quality Assurance Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Corporate Quality Assurance department at our Thousand Oaks headquarters is looking for an undergraduate student interested in a 10 – 12 week internship responsible for the following: Amgen is using a risk based approach to equipment qualification, as part of the development of the program we have identified the following tasks: • Reviewing and transferring equipment risk assessments into the company Software (ORMS) to provide a basic technical library. • Putting this information into a database accessible from an internal web site • Identifying associated user requirements and providing a technical commentary to them, incorporating them into the database. • Reviewing this information with the Engineering Technical Authority. We are also looking for ways of improving our documents, and would like to get an independent review of the Quality document hierarchy for Validation, and a critique of the current arrangement – using the information to develop a proposal that will help simplify the structure, and reduce the number of supporting site Standard Operating Procedures. 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 obtaining an undergraduate degree in Life Science, Biomanufacturing Science or Engineering 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 at the time of application • 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 • Ideally have Biomanufacturing experience and an understanding of bioprocessing, to allow interpretation of the risk assessments.United StatesAmgen2012-02-14 20:03:44CaliforniaCAThousand Oaks, CA26520684http://www.amgen.jobs/xml/26520684/jobUSAThousand OaksAuto req 13240BR Job Posting Title Sr Associate Tech Engineering 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 within the Operations Organization in Thousand Oaks. Scope will include a wide range of products including; needle protection systems, autoinjectors, and reconstitution systems. This position will have a strong focus on the development of equipment and methods/procedures involving medical device commercialization. The candidate will be responsible to operate and maintain a variety of custom and standard equipment, including the use of measurement and data acquisition equipment. Responsibilities include lab management, including maintenance and calibration of equipment. The candidate will have a working knowledge of the instrumentation typically applied to GMP equipment. 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 in an engineering or science discipline, with 6 years of experience in the biotechnology or related industry in a technical role preferred. 2 or more years experience with Maximo Computer Maintenance Management System (CMMS) or equivalent maintenance management application, excellent communications skills, both oral and written and work well in multidisciplinary project teams. Ability to work independently as well as in a collaborative environment. Strong analytical skills to identify potential improvement opportunities Demonstrated Competencies/Skills: -Strong background in commercialization process with injectable devices, and experience in or knowledge of processes for the production of novel formulation is also desired. -Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. -Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. - 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 -Industrial 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). -Experience or knowledge in the process development of combination product aspects of these systems for macromolecules is desired. -General knowledge of regulatory, marketing, business development and quality aspects of drug delivery device/system development is also desired. -Experience with partnerships between pharmaceutical and drug delivery companies. Independent thinker with demonstrated skills working in teams or leading project teamsUnited StatesAmgen2012-01-05 22:32:12CaliforniaCAThousand Oaks, CA25725400http://www.amgen.jobs/xml/25725400/jobUSAThousand OaksAuto req 12544BR Job Posting Title Grad Intern - Audit Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Corporate Audit department in our Thousand Oaks location is looking for a Grad student interested in a 10 – 12 week internship. The Corporate Audit department has an opportunity for a first year MBA student to contribute to the internal control documentation and testing requirements in the Sarbanes-Oxley Act of 2002 (SOX). The intern may also be assigned to other financial and operational audits requiring basic audit documentation and testing skills. This assignment will provide the intern with the opportunity to integrate their academic study in accounting, auditing, business administration, and/or finance with practical experience at a Fortune 100 employer. The intern will assist in performing audits to assess our SOX internal control adequacy and effectiveness. The intern will work with the Corporate Audit managers and staff to assist in providing independent, objective assurance and consulting services designed to add value and improve the operations of the Company. Lastly, the intern may help in determining whether the Company's networks of risk management, control and governance processes are adequate and functioning in a manner appropriate to a Company of our size and market. The intern will be asked to understand and discharge their duties and responsibilities in a professional manner that is consistent with company policies and procedures, including the handling of Company confidential and/or sensitive data. The following objectives will be met by the end of the intern assignment: 1. Complete audits on several SOX processes 2. Gain knowledge of basic auditing and accounting skills related to professional auditing standards and as embodied in the Corporate Audit Manual 3. Be introduced to auditing and/or Amgen as a career opportunity 4. Learn about the bio-tech industry and internal controls environments. 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 This position requires a BA/BS degree in computer science, information systems, accounting, finance, business administration, engineering, telecommunications, pharmacy or life science. Prospective candidates must be in the process of completing the first year of their Master of Business Administration (MBA) Degree Program. Minimum of 3 years work experience is required, 2 years of which spent in auditing. 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 1. Excellent oral and written communication skills, presentation skills and interpersonal skills 2. Demonstrates leadership skills 3. Strong organizational, project management, detail oriented, analytical and quantitative skills 4. Demonstrates personal initiative, self-motivation, flexibility and adaptability 5. Ability to effectively operate independently, across functional lines, and with both internal and external customers 6. Ability to work successfully in a team and matrix environment 7. Ideal candidate will have work experience in auditing (preferably with Big 4). 8. CPA Certification. Excellent financial model building skills via Microsoft Excel or other software programs. 9. Ability to speak multiple languages (e.g., Portuguese, Cantonese, Spanish, etc.)United StatesAmgen2011-10-25 20:39:35CaliforniaCAThousand Oaks, CA24410999http://www.amgen.jobs/xml/24410999/jobUSAThousand OaksAuto req 12602BR Job Posting Title Admin Coordinator Career Category Administrative Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Administrative Coordinator (AC) supports the Epogen and Aranesp Nephrology Marketing team and manages key leadership meetings. AC directly supports the Executive Director and two Directors of Marketing. AC would be responsible for comprehensive administrative support, meeting planning, travel planning, and marketing projects. Responsibilities 1. Administrative responsibilities include calendar management, on-site and off-site meeting planning, managing phones, prioritize activities, file maintenance, and confidential information control 2. Communications with internal (team, functions, business unit) and external (customers, vendors) 3. Project tracking and supporting materials review 4. Travel planning and expense management 5. Project assistance with slide development 6. Assist with management of department budget 7. Meeting coordination and management including agenda preparation, capturing actions, and distributing information (Leadership, Marketing, Cross Function Brand Team meetings) 8. Customer and organization visit management 9. Marketing team systems (EDM and Share Point)and procedures maintenance 10. Work collaboratively with ACs within business unit 11. Plan and organize work to ensure accurate and logical organization of files/documents/records, ensure effective control of forms, expense report submission, and control confidentiality of files as necessary. Candidates should demonstrate outstanding written and verbal communication skills, and project management experience. Additional requirements include advanced knowledge of computer software (MS Office i.e., word processing, presentation, spreadsheet and database skills), discretion in dealing with proprietary information, and the ability to understand department specific technical information and seek outside resources as needed. Candidates should also be able to interface with high-level internal and external contacts, establish professional relationships and demonstrate basic understanding of product development processes. 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 information Strong written and oral communication skills. Strong interpersonal skills and ability to work with internal functions and external organizations. Project management skills with ability to multitask, determine priorities, set targets, track to milestones, and complete projects.United StatesAmgen2012-02-03 18:30:05CaliforniaCAThousand Oaks, CA26297162http://www.amgen.jobs/xml/26297162/jobUSAThousand OaksAuto req 13237BR Job Posting Title Grad Intern - Global Statistical Programming Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Program Summary: Amgen's corporate headquarters is located along the southern California coast between Santa Monica and Santa Barbara (40 miles west of Los Angeles). Amgen’s internship program offers meaningful project experiences that impact patient’s lives, competitive compensation, housing benefits (for eligible candidates), executive networking events, social networking events, community volunteer project opportunities, on-site fitness center and much more. Job/Project Description: Amgen’s Global Statistical Programming department at our Thousand Oaks headquarters is looking for a graduate student interested in a 10 – 12 week internship to be a supporting member of a Statistical Programming group responsible for reporting clinical trials data, research and/or develop applications that streamline routine work in this department. Candidate will gain insights into how software technologies are deployed in the biotech and pharmaceutical industry to gain efficiencies in statistical programming. Examples: o Develop SAS macros or other utilities. o Develop or implement enhancements to specific aspects of current Statistical Programming processes 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 Masters degree in Computer Sciences or Statistics • Experience with SAS languages on UNIX systems 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 at the time internship begins; • 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 • Proficient with SAS language • Knowledge of other Statistical softwareUnited StatesAmgen2012-01-13 19:06:39CaliforniaCAThousand Oaks, CA25885816http://www.amgen.jobs/xml/25885816/jobUSAThousand OaksAuto req 13792BR Job Posting Title Principal Engineer - Thermal Packaging Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen Job Description Independently provide and/or direct the characterization of process optimization strategies and/or trouble shooting of operational issues. Apply advanced and diverse engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components in a Thermal Packaging system. This position will provide solutions to a variety of highly complex technical problems of large scope, independently evaluate, select, and/or modify standard engineering techniques, procedures and criteria, perform assignments that have loosely defined objectives that require investigation of a large number of variables and interpret and execute policies and procedures with a thermal and cold chain engineering focus The position will be involved in the selection of thermal packaging materials for both large and small molecules product, performing technical assessments and studies to justify the selected material, writing technical specifications and Bill of Materials for the components and product to be packaged, lead the team in technology transfer from clinical to commercial operations for both components and equipment processes, ensure that line trials and packaging validation is conducted prior to introduction and resolving any packaging related issues at the sites. The candidate will be expected to lead a team and may have direct reports. 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 Bachelor’s degree in Engineering, Science or related technological field with a minimum of 10 years of work experience preferred, with previous experience in the pharmaceutical or biotechnology area. Demonstrated leadership in a wide range of packaging related technologies with strong fundamental knowledge of primary and secondary packaging systems & processes, manufacturing fill finish equipment & processes, material science, and quality systems are essential. The successful candidate will have excellent organizational, project management, technical, problem solving and communication (written & verbal) skills. The candidate must have demonstrated ability to work with a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule. The candidate must also have demonstrated ability to effectively communicate to a diverse audience, at multiple levels within the company, through various formats (orally, powerpoint, etc.,). In addition, candidates must possess strong interpersonal skills, high level of client focus, and an ability to adapt to a rapidly changing environment. Direct experience with pharmaceutical or bio-technology environment is required. Candidate must demonstrate solid technical presentation skills, test protocol writing, organization, analytical problem solving. Must be a proven and experienced leader and have the ability to successfully manage a multitude of projects. The candidate is also expected to encourage and promote the development of innovative, cost effective packaging systems and able to translate industry trends to business opportunities at Amgen. The ability to travel domestically and international is required.United StatesAmgen2012-02-20 20:51:18CaliforniaCAThousand Oaks, CA26631340http://www.amgen.jobs/xml/26631340/jobUSAThousand OaksAuto req 13250BR Job Posting Title Undergrad Intern - Global Health Economics Career Category College Job Employee Subgroup Seasonal FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen’s Global Health Economics department at our Thousand Oaks, CA headquarters is looking for an undergrad student interested in a 10 – 12 week internship responsible for helping the Nplate GHE Lead with the preparation of BIMs (budget Impact Models) for submission. The intern will also be responsible for the following: • Construct Budget Impact Models (BIMs) for several Emerging Markets (EM) • Develop skills in sensitivity analyses • Develop skills in writing concise and compelling summaries of analyses 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 obtaining an Economic or Business Bachelor’s of Science Degree • Has some experience with Excel 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 year of study at the time of application • 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 • Good mastery of managerial economics and capital budgeting • Intermediate knowledge of Excel • Familiarity with health economicsUnited StatesAmgen2012-02-16 21:58:26CaliforniaCAThousand Oaks, CA26576271http://www.amgen.jobs/xml/26576271/jobUSAThousand OaksAuto req 13462BR Job Posting Title Sr Associate QA - Bulk Manufacturing Career Category Quality Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Bulk Quality Assurance provides quality and compliance oversight of the Clinical Bulk Drug Substance manufacturing plant. This includes, cell culture, fermentation, and purification processes as well as plant support functions such as maintenance, metrology, engineering, and automation. Responsibilities: Provide Quality Assurance oversight for bulk manufacturing operations for clinical biopharmaceutical products. Ensure compliance to GMP regulations for area operations and associated processes. Support investigations/deviation reports (nonconformance reports) Management of GMP documentation, including real time manufacturing document review, approval, and archiving Provide plant floor Quality oversight to maintain an inspection ready facility as part of 80% time on the manufacturing floor May be asked to give additional assistance to management within the Quality Assurance group as needed Basic Qualifications Master’s degree OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and 6 years of directly related experience OR High school diploma / GED and 8 years of directly related experience Preferred Qualifications Bachelor’s Degree in Biochemistry, Biology, Chemistry or related science field 3 or more years of experience in a Quality Assurance or related role, ie, supporting GMP functions such as Non Conformance root cause analysis Demonstrated science based approach and ability to deliver results Experience working in multiple GMP databases Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices Experience in reviewing and approval of batch records, NC/CAPA's and Change Control records Demonstrated ability to use computer databases for query of data, managing status, and input of data and documentation Previous experience in Amgen’s quality systems (SAP, LIMS, Change Control (CCMS), Trackwise, EDMQ) Ability to focus on detail and ensure accuracy of execution tasks, documentation per GMP standards Demonstrated experience creating deviation technical assessments or equivalent Effective verbal and technical written communication skills, strong interpersonal skills to i.e. articulate quality requirements and rationale to others Knowledgeable of regulatory requirements/Quality Principles Able to effectively handle and operate in a rapidly changing environment Strong team player Complex decision making skills and ability to complete tasks autonomously, provide updates to area manager, and identify potential issuesUnited StatesAmgen2012-01-19 22:54:11CaliforniaCAThousand Oaks, CA25996877http://www.amgen.jobs/xml/25996877/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 oncologyUnited StatesAmgen2012-02-16 21:58:36CaliforniaCAThousand Oaks, CA26576276http://www.amgen.jobs/xml/26576276/jobUSAThousand OaksAuto req 13637BR Job Posting Title Admin Coordinator Career Category Administrative Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Administrative Coordinator (AC) will be primarily responsible for complex administrative support activities, supporting multiple Directors/Sr Managers in the Clinical Quality 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 experience directly related to the job -High school diploma / GED & 4 years of experience directly related to the job 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 informationUnited StatesAmgen2012-02-08 02:39:08CaliforniaCAThousand Oaks, CA26389651http://www.amgen.jobs/xml/26389651/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 programUnited StatesAmgen2012-02-16 21:59:19CaliforniaCAThousand Oaks, CA26576291http://www.amgen.jobs/xml/26576291/jobUSAThousand OaksAuto req 13927BR Job Posting Title Global Regulatory Affairs & Safety Operations Director - GRAAS Strategy and External Operations Career Category Safety Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Purpose: This role leads key Amgen Global Regulatory Affairs & Safety (GRAAS) initiatives spanning Strategy and External Operations group. The role purpose is to: • Develop and execute transformational business strategies • Partner with GRAAS leaders on selection, implementation, and reporting of strategic initiatives • Design and lead process improvements efforts and focus on productivity improvement • Optimize the GMAD operating model, develop and execute business and organizational integration strategies • Partner with GRAAS executives and Regional Teams to conduct integration activities, and provide hands-on leadership of integration efforts • Support other GSEO strategies Key Activities: • Directly and indirectly manage project teams that enact strategic development of GRAAS • Assure achievement of desired ROI and/or organizational change from initiatives under S&P leadership • Hands-on leadership of strategic programs and process improvements through planning and implementation • Support development of GRAAS Performance Scorecards, their measurement and subsequent strategy development • Support of various operational outsourcing initiatives, etc by partnering with program leads and providing cross-functional guidance • Develop financial and operational models to ensure achievement of business benefits from sourcing strategy • Secure ELT approval of strategic initiatives by determining validity, expected ROI, and risk:benefit effects on the organization • Define, implement and lead GMAD projects supporting and facilitating global cross-functional integration activities for various size and type mergers and acquisitions • Directly and indirectly oversee and lead project teams that perform GMAD activities • Support Regional Regulatory and Safety heads during due diligence phase, including due diligence assessment pack development and report creation • Provide strategic guidance, planning and execution leadership to GRAAS integration teams and functional leadership for post-merger integrations • Partner with PDO (Partner & distributor Operations) function to implement operational models and best practices for lifecycle management of external relationships 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: • Experience interacting and communicating with senior executives on strategic subjects • Experience communicating and presenting clearly on strategic and business issues • Experience 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 • Understanding of financial modeling and business value forecasting • Deep knowledge of strategic management, performance improvement, and change management models • Proficiency in anticipating and resolving problems • Understanding of information technology and R&D systems including safety and regulatory technologies • 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 biopharmaceutical industry • Experience engaging in regulatory and safety policy development and implementation • Experience leading at a functional level and working in a global matrix environment • Experience working in a global environmentUnited StatesAmgen2012-02-16 21:58:52CaliforniaCAThousand Oaks, CA26576281http://www.amgen.jobs/xml/26576281/jobUSAThousand OaksAuto req 13973BR Job Posting Title Medical Communications Senior Manager - Inflammation Therapeutic Area Career Category Medical Affairs Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The successful candidate will provide clinical and strategic input on Medical Communications activities in support of therapeutics related to the treatment of inflammatory diseases. Key internal partners for this role will include Clinical Development, Medical Information, Biostatistics, Global Health Economics, Global Medical Writing, Safety, Training, Marketing, Global Commercial, Legal, and Regulatory Affairs. Reporting to the Inflammation Medical Communications Director, the senior manager will be responsible for providing scientifically rigorous and high impact support of scientific affairs activities. Primary responsibilities include reviewing field based promotional and educational materials for scientific accuracy, providing clinical support of key scientific congresses including creation of scientific affairs booths, and management of project associated budget and resources (including strategic vendors). Additional responsibilities may include the development and management of scientific platforms, publication plans, advisory boards, and resources for Regional Medical Liaisons. Some travel may be required — approximately 10%. 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 Preferred Qualifications - PharmD, PhD, MD, DO (other Doctorate Degrees may be considered) with 3 or more years of cumulative experience in Clinical Research, patient care, Clinical Development, Medical/Scientific Affairs and/or basic research. - Prior experience in Medical Affairs or Clinical Development within the biopharmaceutical industry, or clinical experience, in the areas of inflammation/immunology, dermatology or rheumatology - Understanding of Medical Communications projects including disease state education programs, advisory boards, congress/publication plans and RML resources - Experience with late-stage products or joint ventures - Excellent written, oral, and presentation skills and the ability to critically analyze the scientific literature to form logical opinions - An understanding of the pharmaceutical commercialization process, and knowledge of the legal and regulatory guidelines affecting promotion of prescription products - The ability to work in teams and interface in a dynamic environment across corporate functions - Prior experience managing consultants and vendors is desired.United StatesAmgen2012-02-16 21:58:18CaliforniaCAThousand Oaks, CA26576265http://www.amgen.jobs/xml/26576265/jobUSAThousand Oaks - Field BasedAuto req 8415BR Job Posting Title Sr Biopharmaceutical Rep, Bone Health - Reno, NV Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - California Location (City) Thousand Oaks - Field Based Amgen Job Description Territory – 58912 Reno, NV covering Reno, Carson City & Northern half of Nevada 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 AchieveUnited StatesAmgen2012-02-15 22:00:36CaliforniaCAThousand Oaks - Field Based, CA26547308http://www.amgen.jobs/xml/26547308/jobUSAThousand Oaks - Field BasedAuto req 11198BR Job Posting Title Sr Biopharmaceutical Rep, Bone Health - Toledo, Ohio Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - California Location (City) Thousand Oaks - Field Based Amgen Job Description Territory – 52113 Toledo, Ohio covering northwestern Ohio (to the Indiana/Michigan borders) 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 AchieveUnited StatesAmgen2012-02-15 22:00:50CaliforniaCAThousand Oaks - Field Based, CA26547327http://www.amgen.jobs/xml/26547327/job