Director Drug Substance Manufacturing, Amgen Thousand Oaks

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The B23 Director Manufacturing Systems is responsible for leading manufacturing operations within a drug substance GMP plant at the Thousand Oaks campus. The plant plays a meaningful role within Amgen's manufacturing network producing both clinical and commercially-licensed drug substance products. The position provides direct experience in a high-mix and low-volume environment and deployment of new manufacturing technologies. The Manufacturing Systems team is a key communication and technical interface between the GMP manufacturing team in the plant and Process Development, Quality, Operational Strategy and Risk (OSPR), Supply Chain, Facilities & Engineering, Finance, and Amgen networks.

The Manufacturing Systems team is accountable for:

  • Agile and reliable clinical/commercial new product introduction and lifecycle management
  • New manufacturing technology implementation
  • Electronic batch record configuration and maintenance
  • Strategy and maintenance of cleaning and sterilization validation programs
  • Single-use system design, deployment, and defect support
  • Process ownership inclusive of CAPA, change control, and project management
  • Finite scheduling of plant operations
  • Business operations such as planning, governance management, performance reporting, financial management, and digital advancement

The leader will recommend staff to ensure plant goals are met and represent the manufacturing organization on projects, site and network teams. The leader is encouraged to:
  • Anticipate and adapt to environmental factors
  • Champion innovation and continuous improvement
  • Build compelling strategies the help deliver the company's aspiration
  • Recruit, retain and develop hard-working and teams with varied strengths
  • Set enthusiastic performance expectations and provides timely feedback
  • Build empowered teams that put patients and Amgen first
  • Establish sound plans the enable Amgen's operational and strategic imperatives
  • Execute with a sense of purpose and drives course correction where appropriate
  • Deliver strong results consistent with compliance requirements and Amgen values.


Specifically, the responsibilities for this position are:

  • Collaborate with multi-functional teams to complete production enabling activities
  • Drive continuous improvement initiatives, programs and projects
  • Deploy new manufacturing technologies to advance manufacturing strategy
  • Ensure that the requirements of the Quality Management System are fulfilled
  • Alert senior management of noteworthy quality, compliance, supply and safety risks
  • Provide recommendations for management reviews
  • Forecast and enforce to a budget for assigned areas


Basic Qualifications:

Doctorate degree and 4 years of manufacturing experience

OR

Master's degree and 8 years of manufacturing experience

OR

Bachelor's degree and 10 years of manufacturing experience

And

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or advocate the allocation of resources

Preferred Qualifications:

  • Currently in a leadership position in a GMP manufacturing plant
  • Experience in drug substance manufacturing operations for commercially licensed products
  • Experience with the process validation lifecycle inclusive of process design, process performance qualification, and continued process verification
  • 6 years managing a team, leading and managing operations
  • 2 years experience in applying operational excellence and lean manufacturing principles to drug substance manufacturing
  • Excellent communication and negotiation skills including executive level communication
  • Experience in a matrixed, cross-site or global network environments


#operation21

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.

Amgen requires all staff in the United States and Puerto Rico 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.

Join Us

If 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.

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