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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 developing a team of expert 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, chip in to production scheduling decisions, and work cross-functionally to close nonconformance investigations and introduce new product skus.
Job Responsibility
Staff selection, training, oversight, performance, 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 performing unit operations, batch record review is completed accurately meeting disposition timelines, and non-conformances are initiated & closed with right the first time documentation
Using appropriate systems for job duties (SAP, QMTS, and LIMS etc.) and 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 required
Working 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 complete both near-term schedule and long-term strategy
Requirements
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
experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Nice to have
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 understanding 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
What we offer
health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
Retirement and Savings Plan with generous company contributions