Director Drug Substance Manufacturing, Amgen Thousand Oaks - #390267


Date: 08/19/2021 20:00 PM

City: Thousand Oaks, California

Contract type: Full Time

Work schedule: Full Day

Career Category


Job Description

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 critical 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 strategic planning, governance management, performance reporting, financial management, and digital advancement

The leader will direct staff to ensure plant goals are met and represent the manufacturing organization on projects, site and network teams. The leader is expected to:

  • Anticipate and adapt to environmental factors
  • Champion innovation and continuous improvement
  • Create compelling strategies the help deliver the company’s aspiration
  • Recruit, retain and develop high-performing and diverse teams
  • Set challenging 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 cross-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 significant quality, compliance, supply and safety risks
  • Provide input for management reviews
  • Forecast and adhere to a budget for assigned areas

Basic Qualifications:

Doctorate degree and 4 years of manufacturing experience


Master’s degree and 8 years of manufacturing experience


Bachelor’s degree and 10 years of manufacturing experience


4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing 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


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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