Amgen Manager Manufacturing, Drug Product in Thousand Oaks, California

The Amgen Thousand Oaks, Building 20 Drug Product Manufacturing facility directly supports Amgen's pipeline of clinical drug product supply to patients across the globe. The Manager Manufacturing - Drug Product role offers the opportunity to collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, Regulatory Compliance, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility.

The Manager Manufacturing is responsible for leading a team of experienced manufacturing associates and technicians within Drug Product operations, while championing a safe and compliant production environment through structured on-floor presence.

In this position, the manager will ensure production areas and procedures remain in compliance with current Good Manufacturing Practices, set and measure team performance/goals, contribute to production scheduling decisions, and work cross-functionally to close nonconformance investigations and introduce new product skus.

The Manager Manufacturing will be specifically responsible for:

  • Staff selection, training, oversight, performance evaluations, and development.

  • Schedule adherence for tasks including, but not limited to manufacturing, qualification, and maintenance activities.

  • Participating as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.

  • Elevating critical and impactful events to senior management and make real time processing decisions.

  • Ensuring standard operating procedures are accurate for executing unit operations, batch record review is completed accurately meeting disposition timelines, and non-conformances are initiated & closed with right the first time documentation

  • Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.). Identifies and implements process and safety improvements. Communicate production floor and project work at different levels of management.

  • Interacting with business partners and internal/external audit teams including regulatory agencies as directed.

  • Interacting with business partners to assist with scheduling of maintenance tasks, engineering evaluations, and quality investigations.

  • Supporting the introduction of new products and technologies into the facility. Troubleshoot and perform initial assessment of events that have the potential to impact area safety and product quality.

  • Assessing departmental utilization to execute both near-term schedule and long-term strategy.The Manager Manufacturing will be specifically responsible for:

  • Staff selection, training, oversight, performance evaluations, and development.

  • Schedule adherence for tasks including, but not limited to manufacturing, qualification, and maintenance activities.

  • Participating as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.

  • Elevating critical and impactful events to senior management and make real time processing decisions.

  • Ensuring standard operating procedures are accurate for executing unit operations, batch record review is completed accurately meeting disposition timelines, and non-conformances are initiated & closed with right the first time documentation

  • Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.). Identifies and implements process and safety improvements. Communicate production floor and project work at different levels of management.

  • Interacting with business partners and internal/external audit teams including regulatory agencies as directed.

  • Interacting with business partners to assist with scheduling of maintenance tasks, engineering evaluations, and quality investigations.

  • Supporting the introduction of new products and technologies into the facility. Troubleshoot and perform initial assessment of events that have the potential to impact area safety and product quality.

  • Assessing departmental utilization to execute both near-term schedule and long-term strategy.

Basic Qualifications:

Doctorate degree OR

Master's degree and 3 years of drug product manufacturing or operations experience OR

Bachelor's degree and 5 years of drug product manufacturing or operations experience OR

Associate's degree and 10 years of drug product manufacturing or operations experience OR

High school diploma / GED and 12 years of drug product manufacturing or operations experience AND

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

  • At least 10 years of biopharmaceutical experience, with 3 years of leadership experience directly within drug product manufacturing that includes aseptic and sterile filling environments

  • Bachelor's or Master's degree in Microbiology, Life Sciences, Business or a related field

  • Strong working knowledge of lean concepts and application within a regulated manufacturing environment

  • Effective at working in fast-paced environments, specifically in a leadership capacity to facilitate objective decision making

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.