[{"country_short": "USA", "city": "West Greenwich", "description": "Auto req 15708BR\nJob Posting Title Sr Mgr Information Systems (Automation)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Rhode Island\nLocation (City) West Greenwich\nAmgen 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.\n\nResponsibilities include:\n\n\n- Establishing strategy and direction for automation in support of strategic business needs as it pertains to multiproduct commercial and clinical biopharmaceutical manufacturing.\n- Providing direct and indirect supervision of full time staff plus supplemental contractors as needed to support project activities.\n- 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.\n- Supporting the ongoing enhancement and optimization of automation systems by using a cGMP change management and software development lifecycle approach.\n- Providing solutions to a wide range of difficult problems by applying industry wide knowledge in the development of automation systems.\n- Translating strategic business needs into a project methodology framework.\n- Driving continuous improvement and high reliability performance by building a culture of innovation, organizational learning and zero defect thinking.\n- Managing non-conformance, corrective and preventive actions for automation systems.\n- Providing direction and resource prioritization relative to multiple projects, programs and on-going initiatives.\n- 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.\n- Interacting with senior internal and external personnel, often requiring coordination between organizations.\n- 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.\n- Providing 7x24 escalation support for major manufacturing automation issues.\n- Other functions may be assigned.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience OR\n\u2022 Master\u2019s degree & 6 years of directly related experience OR\n\u2022Bachelor\u2019s degree or & 8 years of directly related experience OR\n\u2022 Associate\u2019s degree & 10 years of directly related experience OR\n\u2022 High school diploma / GED & 12 years of directly related experience\n\u2022 AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Advanced degree in Engineering or Life Science.\n\n\u2022 8+ years of biopharma experience with 5+ years experience in operations/manufacturing, to include cGMP regulated, Delta V process control/automation.\n\n\u2022 4+ years of supervisory experience with demonstrated skills in staff motivation, coaching/mentoring and professional development.\n\n\u2022 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.\n\n\u2022 Demonstrated skill in the practical application of Engineering principals and Project Management techniques.", "date_new": "2012-05-15 20:52:36", "url": "http://www.amgen.jobs/xml/28712128/job", "country": "United States", "company": "Amgen", "title": "Sr Mgr Information Systems (Automation)", "reqid": "15708BR", "state": "Rhode Island", "state_short": "RI", "location": "West Greenwich, RI", "uid": 28712128}, {"country_short": "USA", "city": "West Greenwich", "description": "Auto req 15543BR\nJob Posting Title Sr Mgr Supply Chain\nCareer Category Supply Chain\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Rhode Island\nLocation (City) West Greenwich\nAmgen 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.\n\nResponsibilities include:\n\n\u2022 Ownership of site production planning, including coordination, communication, key assumption development and scenario planning\n\u2022 Continuously drive improvement in Supply Chain process\n\u2022 Actively monitor and mitigate supply related risks, including external and internal influences\n\u2022 Successfully lead and build the Supply Chain team\n\u2022 Create strong partnerships with corporate counterparts and global stakeholders\n\nPosition Specific Tasks:\nStrategic Influence\n\u2022 Independently determines planning approach to managing daily operations, guided by Amgen policies and management guidance\n\u2022 Develops and communicates plans/objectives to team\n\u2022 Contributes to site and functional strategy\n\u2022 Ensures consistent practices across network\n\u2022 Delivers results through professional employees\n\u2022 Develops and monitors Department budgets and goals\n\u2022 Provides guidance and technical direction to team and site\n\u2022 Institutes standards for Supply Chain management and Strategic Planning\n\nRelationship Focus\n\u2022 Develops relationships with cross-functional/network at various management levels to resolve issues and optimize overall Supply Chain\n\u2022 Takes accountability of the day-to-day Supply Chain operations\n\u2022 Partners with Operational Excellence leaders to ensure alignment on commercialization and tech transfer processes\n\u2022 Partners with TA Heads, GOLs, ED Ops Improvement, Corporate Alliance Management to ensure alignment on key cross-functional/product processes and communication\n\nLeads Supply Chain Function\n\u2022 Provides people/performance management, coaching and mentoring of staff\n\u2022 Directs staff on strategic and tactical content/approach\n\u2022 Builds, maintain, and retain successful team\n\u2022 Elevates issues in a timely manner\n\u2022 Focuses on Operational Excellence as a means of driving continuous improvement\nBasic Qualifications Doctorate degree and 2 years of directly related experience\n\nOR\n\nMaster\u2019s degree and 6 years of directly related experience\n\nOR\n\nBachelor\u2019s degree or and 8 years of directly related experience\n\nOR\n\nAssociate\u2019s degree and 10 years of directly related experience\n\nOR\n\nHigh school diploma / GED and 12 years of directly related experience\n\nAND\n\n2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Bachelor\u2019s degree in business, engineering, life or physical sciences;\n\u2022 Advanced degree in science, engineering, or business (MBA).\n\u2022 Skills and experience to include:\no Demonstrates the Amgen\u2019s Values\no Excellent interpersonal skills\no Exceptional ability to work cross-functionally and build collaborative working relationships\no Strong communication and presentation skills (verbal & written) ; ability to interface effectively with Ops Senior and Executive Management to resolve issues\no Excellent communication capabilities vertically and horizontally; ability to leverage contact network to enable cross-functional collaboration; ability to influence\no 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\no Certified or experience in process improvement methodologies such as Lean/Six Sigma\no Planning / negotiation / coaching & project management skills\no Results oriented, strong adherence to timelines\no Excellent ability to translate knowledge and build high performing teams\no Strong analytical and problem solving skills\no Self-leadership & motivation", "date_new": "2012-05-01 18:59:14", "url": "http://www.amgen.jobs/xml/28303394/job", "country": "United States", "company": "Amgen", "title": "Sr Mgr Supply Chain", "reqid": "15543BR", "state": "Rhode Island", "state_short": "RI", "location": "West Greenwich, RI", "uid": 28303394}, {"country_short": "USA", "city": "West Greenwich", "description": "Auto req 13625BR\nJob Posting Title Sr Project Mgr\nCareer Category Project Management\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Rhode Island\nLocation (City) West Greenwich\nAmgen 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.\n\nThe 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\u2019s business.\n\nThis 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.\n\nPrimary 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.\n\nThe PMO leads a wide breadth of projects, including:\n\n- New Product Introductions and Tech Transfers\n- Large Capital Projects\n- Process related improvements (i.e., next generation product introductions)\n- Global System deployments (i.e., SAP/ERP/MES)\n- Operational Excellence initiatives (e.g., Business process improvements, supplier relationship initiatives, etc.)\n\nUnder 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.\nBasic Qualifications ? Doctorate degree & 2 years of directly related experience\nOR\n? Master\u2019s degree & 6 years of directly related experience\nOR\n? Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Project management Professional (PMP) certification\n\u2022 Strong knowledge of biotech manufacturing processes and/or Amgen information systems\n\u2022 Strong leadership and motivational skills\n\u2022 Strong project management skills\n\u2022 Experience leading large cross-functional teams\n\u2022 Demonstrated ability to forge and maintain strong relationships within multiple functional areas\n\u2022 Ability to tactfully and effectively negotiate and influence\n\u2022 Ability to communicate and present ideas to all levels of staff and management\n\u2022 Ability to multi-task and function in a dynamic environment\n\u2022 Experience leading teams or organizations (e.g. management of direct staff)\n\u2022 High proficiency in project management methodology and tools (e.g., MS Project, @RISK, etc.)\n\u2022 Understanding of operational excellence, including continuous improvement methodologies (e.g., Lean, Six Sigma, Catalyst, etc.)", "date_new": "2012-01-30 23:42:37", "url": "http://www.amgen.jobs/xml/26200954/job", "country": "United States", "company": "Amgen", "title": "Sr Project Mgr", "reqid": "13625BR", "state": "Rhode Island", "state_short": "RI", "location": "West Greenwich, RI", "uid": 26200954}, {"country_short": "USA", "city": "West Greenwich", "description": "Auto req 12850BR\nJob Posting Title Sr Specialist Manufacturing\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Rhode Island\nLocation (City) West Greenwich\nAmgen Job Description Manufacturing Senior Specialist Description:\n\nIndependently 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.\n\nApply 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.\n\nIndependently make complex decisions regarding operations, process or business practices. Lead cross-functional teams through implementation of major projects, corrective and preventative actions.\n\nApplied Process Expertise\n1. Serve as subject matter expert in manufacturing.\n2. Provide real time support for production manufacturing failures and recovery.\nNon-Conformance and CAPA\n3. May be responsible for managing the site NC and CAPA program for manufacturing.\nProcess and Equipment Validation\n4. May serve as a liaison and coordinator for manufacturing validation activities.\n5. Lead process validation projects.\nCompliance\n6. Support regulatory inspections by directly interfacing with inspectors to review batch records, process validation, non-conformances, etc.\n7. Present process overviews to inspectors and accompany inspectors on tours of process areas.\n8. May serve as a quality system owner.\nChange Control\n9. Serve as a manufacturing change owner for major change controls\nProjects and Initiatives\n10. Serve as a project manager of cross-functional projects.\n11. May represent manufacturing on site and global teams and initiatives.\n\n** Other functions that may be assigned\nBasic Qualifications Doctorate degree and 2 years of directly related experience\n\nOR\n\nMaster\u2019s degree and 6 years of directly related experience\n\nOR\n\nBachelor\u2019s degree and 8 years of directly related experience\n\nOR\n\nAssociate\u2019s degree and 10 years of directly related experience\n\nOR\n\nHigh school diploma / GED and 12 years of directly related experience\nPreferred Qualifications Scientific degree in Life Sciences or Physical Sciences or Applied\nEngineering or Manufacturing Technologies\n\nPrevious technical experience managing people, and leading teams on major\nprojects, initiatives or programs\n\nAseptic processing practical experience\n\nDemonstrated proficiency of written and verbal communication skills\n(including technical writing and technical presentations) Ability to communicate and collaborate effectively with technical and senior management staff.\n\nTrack record of increasingly complex manufacturing or manufacturing support\nexperience in biotechnology, pharmaceuticals or a related industry\n\nExperience that has provided the candidate with a detailed understanding of\nthe regulatory and compliance environment, the GMP processes and the\nbusiness processes associated with typical biotechnology / pharmaceutical\nmanufacturing operations\n\nExperience leading cross-functional teams in investigations into manufacturing deviations and determination of potential manufacturing impact and root cause, and application of corrective actions.\n\nAble to solve complex problems and make scientific risk based recommendations under ambiguous circumstances\n\nExperience representing Amgen while interacting with representatives of regulatory agencies.\n\nExperience in managing multiple, competing priorities in a fast paced environment.", "date_new": "2011-12-02 22:30:56", "url": "http://www.amgen.jobs/xml/25162784/job", "country": "United States", "company": "Amgen", "title": "Sr Specialist Manufacturing", "reqid": "12850BR", "state": "Rhode Island", "state_short": "RI", "location": "West Greenwich, RI", "uid": 25162784}]