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Specialist Manufacturing

Company: Amgen
Location: Newbury Park
Posted on: November 26, 2022

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.Specialist ManufacturingLiveWhat you will doLets do this. Lets change the world. In this vital role you will work as a member of the Drug Product Assembly & Packaging organization, this role serves as a key process leader for New Process Introductions (NPI) and Technology Transfers (TT) into the clinical manufacturing facility. The specialist will serve as the clinical manufacturing operations representative for various Drug Product teams throughout the clinical/commercialization process. A high degree of interaction is required with Clinical Planning, Supply Chain, Quality, Engineering, Process Development, Global Operations teams, Device Technologies, and other supporting groups.

  • Primary responsibilities include assessment of NPIs and TTs for necessary process, facility/equipment, materials, and training modifications; development of NPI/TT implementation plans in accordance to current business processes; ensuring TT information is completed and sufficient for manufacturing implementation; and coordination/execution of required NPI activities, which may include document preparation/revisions, change control management, manufacturing process modifications, equipment introductions/modifications, and supporting validation/engineering runs.
  • The position will support and/or be responsible for proper execution of manufacturing/quality systems such as non-conformances, process qualification/validation, procedures, training, and design/tech transfer for the clinical packaging and device assembly processes. The individual will need to apply process experience, operational expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
  • Work with various NPI/TT support groups to develop, maintain, and implement the NPI/TT project plan. Specialist will function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner and customer concern to various levels of management as appropriate.
  • Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks.
  • Facilitate the development and optimization of NPI/TT business processes. As applicable, serve as a representative on various global network teams or network-sponsored initiatives to advance the Final Drug Product operational practices and technologies.
  • Collaborate with Final Product Technologies, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI/TT.
  • Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control results, and specifications). Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies.
  • Support a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations.WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a collaborative partner with these qualifications.Basic Qualifications:
    • Doctorate degree OR
    • Masters degree & 3 years of directly-related manufacturing experience OR
    • Bachelors degree & 5 years of directly-related manufacturing experience OR
    • Associates degree & 10 years of directly-related manufacturing experience OR
    • High school diploma / GED & 12 years of directly-related manufacturing experiencePreferred Qualifications:
      • Engineering experience with process equipment design, construction, commissioning, and qualification
      • Experience with combination product/device design development and manufacturing
      • Knowledge and expertise in device design control, design transfer, and combination products manufacturing
      • Experience with the development and maintenance of device master records, device history records, and process risk assessments (pFMEA)
      • Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.)
      • Fundamentally sound project management/organization, technical writing, digital literacy, and communication/presentation skills
      • Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
      • Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
      • Excellent teammate prepared to work in and adopt a team-based culture that relies on collaboration for effective decision-making
      • Experienced in balancing multiple, opposing priorities in a fast-paced environment
      • Ability to optimally communicate sophisticated technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing formsThriveWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
        • Vast opportunities to learn and move up and across our global organization
        • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
        • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsApply nowfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.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 world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Keywords: Amgen, Los Angeles , Specialist Manufacturing, Other , Newbury Park, California

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