Amgen Jobshttp://www.amgen.jobs2012-05-26 20:41:32.209622USAWest GreenwichAuto req 15708BR Job Posting Title Sr Mgr Information Systems (Automation) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - Rhode Island Location (City) West Greenwich Amgen Job Description The Sr Mgr IS - Automation leads a group of engineers to provide automation technical and engineering support for the 24x7 manufacture of biopharmaceuticals. This individual will define automation strategy and manage the automation team to deliver high quality requirements, design, implementation, commissioning, qualification, operation and maintenance of computer related systems to meet business expectations in a GAMP and cGMP compliant manner. Responsibilities include: - Establishing strategy and direction for automation in support of strategic business needs as it pertains to multiproduct commercial and clinical biopharmaceutical manufacturing. - Providing direct and indirect supervision of full time staff plus supplemental contractors as needed to support project activities. - Working with engineering, process development, manufacturing and quality groups to provide support for the design, installation, start-up, validation and operation of facility and/or process equipment. - Supporting the ongoing enhancement and optimization of automation systems by using a cGMP change management and software development lifecycle approach. - Providing solutions to a wide range of difficult problems by applying industry wide knowledge in the development of automation systems. - Translating strategic business needs into a project methodology framework. - Driving continuous improvement and high reliability performance by building a culture of innovation, organizational learning and zero defect thinking. - Managing non-conformance, corrective and preventive actions for automation systems. - Providing direction and resource prioritization relative to multiple projects, programs and on-going initiatives. - Guiding the successful completion of complex projects by applying extensive technical and managerial expertise in the design, maintenance and alteration of automation systems to meet scope, schedule, quality and management strategic objectives. - Interacting with senior internal and external personnel, often requiring coordination between organizations. - Understanding regulatory trends in industry. Direct experience with FDA or equivalent regulatory body is required. Acts as the primary automation technical lead during internal and external audits. - Providing 7x24 escalation support for major manufacturing automation issues. - Other functions may be assigned. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR •Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience • AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Advanced degree in Engineering or Life Science. • 8+ years of biopharma experience with 5+ years experience in operations/manufacturing, to include cGMP regulated, Delta V process control/automation. • 4+ years of supervisory experience with demonstrated skills in staff motivation, coaching/mentoring and professional development. • Technical expertise with batch process control systems and industry standards, including ISA S88, S95 and GAMP. Familiarity with DCS, MES, BAS and PLC/SCADA systems. • Demonstrated skill in the practical application of Engineering principals and Project Management techniques.2012-05-15 20:52:36United StatesAmgenRhode Island15708BRRIWest Greenwich, RI28712128http://www.amgen.jobs/xml/28712128/jobUSAWest GreenwichAuto req 15543BR Job Posting Title Sr Mgr Supply Chain Career Category Supply Chain Employee Subgroup Salaried FT Country (State/Region) United States - Rhode Island Location (City) West Greenwich Amgen Job Description The Senior Manager of Supply Chain will be responsible for the successful management of the Supply Chain team including bulk drug substance end to end Supply Chain activities, including site strategic planning, production planning and raw material procurement. Responsibilities include: • Ownership of site production planning, including coordination, communication, key assumption development and scenario planning • Continuously drive improvement in Supply Chain process • Actively monitor and mitigate supply related risks, including external and internal influences • Successfully lead and build the Supply Chain team • Create strong partnerships with corporate counterparts and global stakeholders Position Specific Tasks: Strategic Influence • Independently determines planning approach to managing daily operations, guided by Amgen policies and management guidance • Develops and communicates plans/objectives to team • Contributes to site and functional strategy • Ensures consistent practices across network • Delivers results through professional employees • Develops and monitors Department budgets and goals • Provides guidance and technical direction to team and site • Institutes standards for Supply Chain management and Strategic Planning Relationship Focus • Develops relationships with cross-functional/network at various management levels to resolve issues and optimize overall Supply Chain • Takes accountability of the day-to-day Supply Chain operations • Partners with Operational Excellence leaders to ensure alignment on commercialization and tech transfer processes • Partners with TA Heads, GOLs, ED Ops Improvement, Corporate Alliance Management to ensure alignment on key cross-functional/product processes and communication Leads Supply Chain Function • Provides people/performance management, coaching and mentoring of staff • Directs staff on strategic and tactical content/approach • Builds, maintain, and retain successful team • Elevates issues in a timely manner • Focuses on Operational Excellence as a means of driving continuous improvement Basic Qualifications Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree or and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Bachelor’s degree in business, engineering, life or physical sciences; • Advanced degree in science, engineering, or business (MBA). • Skills and experience to include: o Demonstrates the Amgen’s Values o Excellent interpersonal skills o Exceptional ability to work cross-functionally and build collaborative working relationships o Strong communication and presentation skills (verbal & written) ; ability to interface effectively with Ops Senior and Executive Management to resolve issues o Excellent communication capabilities vertically and horizontally; ability to leverage contact network to enable cross-functional collaboration; ability to influence o Comfort with complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and facilitate decision-making o Certified or experience in process improvement methodologies such as Lean/Six Sigma o Planning / negotiation / coaching & project management skills o Results oriented, strong adherence to timelines o Excellent ability to translate knowledge and build high performing teams o Strong analytical and problem solving skills o Self-leadership & motivation2012-05-01 18:59:14United StatesAmgenRhode Island15543BRRIWest Greenwich, RI28303394http://www.amgen.jobs/xml/28303394/jobUSAWest GreenwichAuto req 13625BR Job Posting Title Sr Project Mgr Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - Rhode Island Location (City) West Greenwich Amgen Job Description The Project Management Organization (PMO) is responsible for Program and Project Management, Project Portfolio Management and Project Support functions at the Amgen Rhode Island (ARI) site. The Senior Project Manager position presents an opportunity for a qualified candidate to further enhance their leadership skills, apply proficiency in project management to effectively manage large, highly complex programs, demonstrate versatility, and cultivate financial acumen and overall understanding of Amgen’s business. This highly visible position interacts with all levels of the organization. The candidate must have a proven track record in project management, strong leadership and communication skills, and the ability to approach issues from a strategic perspective. This includes the ability to translate strategy into challenging, actionable objectives to effectively drive cross functional teams, advocate client positions throughout the project life cycle, and make value-based decisions. Primary responsibilities include leadership of multi-faceted, cross-functional and global projects as well as mentoring less experienced project managers at the Amgen Rhode Island site. The PMO leads a wide breadth of projects, including: - New Product Introductions and Tech Transfers - Large Capital Projects - Process related improvements (i.e., next generation product introductions) - Global System deployments (i.e., SAP/ERP/MES) - Operational Excellence initiatives (e.g., Business process improvements, supplier relationship initiatives, etc.) Under minimal guidance, the candidate must manage all aspects of their project(s): planning, cost, schedule, risk, communications, resources, team dynamics and performance, implementation, monitoring, completion and follow-up. Basic Qualifications ? Doctorate degree & 2 years of directly related experience OR ? Master’s degree & 6 years of directly related experience OR ? Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Project management Professional (PMP) certification • Strong knowledge of biotech manufacturing processes and/or Amgen information systems • Strong leadership and motivational skills • Strong project management skills • Experience leading large cross-functional teams • Demonstrated ability to forge and maintain strong relationships within multiple functional areas • Ability to tactfully and effectively negotiate and influence • Ability to communicate and present ideas to all levels of staff and management • Ability to multi-task and function in a dynamic environment • Experience leading teams or organizations (e.g. management of direct staff) • High proficiency in project management methodology and tools (e.g., MS Project, @RISK, etc.) • Understanding of operational excellence, including continuous improvement methodologies (e.g., Lean, Six Sigma, Catalyst, etc.)2012-01-30 23:42:37United StatesAmgenRhode Island13625BRRIWest Greenwich, RI26200954http://www.amgen.jobs/xml/26200954/jobUSAWest GreenwichAuto req 12850BR Job Posting Title Sr Specialist Manufacturing Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) United States - Rhode Island Location (City) West Greenwich Amgen Job Description Manufacturing Senior Specialist Description: Independently lead the execution of manufacturing/quality systems such as non-conformance investigations, process validation, major change control initiatives, development of staff training, new product introductions, and corrective and preventative actions. Apply advanced process, operational, scientific expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as the primary production process owner for operations and assist with system ownership responsibilities. Independently make complex decisions regarding operations, process or business practices. Lead cross-functional teams through implementation of major projects, corrective and preventative actions. Applied Process Expertise 1. Serve as subject matter expert in manufacturing. 2. Provide real time support for production manufacturing failures and recovery. Non-Conformance and CAPA 3. May be responsible for managing the site NC and CAPA program for manufacturing. Process and Equipment Validation 4. May serve as a liaison and coordinator for manufacturing validation activities. 5. Lead process validation projects. Compliance 6. Support regulatory inspections by directly interfacing with inspectors to review batch records, process validation, non-conformances, etc. 7. Present process overviews to inspectors and accompany inspectors on tours of process areas. 8. May serve as a quality system owner. Change Control 9. Serve as a manufacturing change owner for major change controls Projects and Initiatives 10. Serve as a project manager of cross-functional projects. 11. May represent manufacturing on site and global teams and initiatives. ** Other functions that may be assigned Basic Qualifications Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies Previous technical experience managing people, and leading teams on major projects, initiatives or programs Aseptic processing practical experience Demonstrated proficiency of written and verbal communication skills (including technical writing and technical presentations) Ability to communicate and collaborate effectively with technical and senior management staff. Track record of increasingly complex manufacturing or manufacturing support experience in biotechnology, pharmaceuticals or a related industry Experience that has provided the candidate with a detailed understanding of the regulatory and compliance environment, the GMP processes and the business processes associated with typical biotechnology / pharmaceutical manufacturing operations Experience leading cross-functional teams in investigations into manufacturing deviations and determination of potential manufacturing impact and root cause, and application of corrective actions. Able to solve complex problems and make scientific risk based recommendations under ambiguous circumstances Experience representing Amgen while interacting with representatives of regulatory agencies. Experience in managing multiple, competing priorities in a fast paced environment.2011-12-02 22:30:56United StatesAmgenRhode Island12850BRRIWest Greenwich, RI25162784http://www.amgen.jobs/xml/25162784/job