Manager Manufacturing - Thousand Oaks CA
About The Position
Amgen is seeking an experienced Manager in drug substance technical operations to lead a team of subject matter experts within the Manufacturing Programs team. The team supports manufacturing through new product and technology introductions, equipment introductions, continual improvement projects, multiproduct facility operations, CAPA and deviation investigations, and implementation and optimization of single-use technologies. The role supports drug substance plants producing material across clinical trial phases through commercial production. The position combines people and project leadership with technical operations work, including technology development and characterization, corrective and preventive actions, plant-floor runs and experiments, work with large-scale equipment, and analysis and communication of data findings. The manager will define and document operating practices, ensure manufacturing documentation accurately reflects operations, implement area improvements, commission equipment, design experiments, and participate in operations meetings. The role also supports operational readiness and delivery of new technologies, equipment, and processes while applying process, scientific, operational, and compliance knowledge. The role is on-site in Thousand Oaks, California. Work may be scheduled across various shifts, weekends, and holidays according to the production schedule. Work in a cleanroom is required, including use of steel-toe shoes and full cleanroom gowning, while following GMP procedures and safety and compliance requirements.
Requirements
- Doctorate degree; or master's degree and 3 years of manufacturing and operations experience; or bachelor's degree and 5 years of manufacturing and operations experience; or associate's degree and 10 years of manufacturing and operations experience; or high school diploma/GED and 12 years of manufacturing and operations experience.
- Experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing allocation of resources. Managerial experience may run concurrently with the required technical experience.
- Availability to work various shifts, weekends, and holidays as directed by the production schedule, including schedules such as 5x8-hour and 4x10-hour shifts.
- Ability to work in a cleanroom wearing steel-toe shoes, full cleanroom gowning, a hairnet, and gloves, while following GMP documents and adhering strictly to safety and compliance requirements.
Nice To Haves
- Degree in Engineering or Life Sciences.
- Experience in GMP technical support, GMP operations, Engineering, or Process Development.
- Technical knowledge of drug substance processing and broad understanding of related disciplinary areas.
- Ability to communicate sophisticated technical information to internal and external colleagues at varying organizational levels through presentations and technical writing.
- Ability to coach, mentor, and/or cross-train colleagues within a core technical area.
- Ability to drive results through leadership of cross-functional teams.
- Experience leading and managing projects and people.
- Equipment and cleaning validation experience.
- Understanding of stainless and single-use technologies.
- Excellent writing skills and experience presenting to leadership or auditors.
- Data analysis and/or data visualization skills.
Responsibilities
- Lead a team of manufacturing specialists and upstream manufacturing subject matter experts.
- Demonstrate strategic problem-solving and champion continual improvement.
- Manage sophisticated projects using project management skills.
- Lead operational readiness of new technologies, equipment, or processes using technical process, scientific, operational, compliance, and project management knowledge.
- Assess and advise on the process impact of changes.
- Develop and own drug substance manufacturing processes and procedures.
- Draft and revise GMP manufacturing documents, including SOPs and forms.
- Draft and develop user requirements for new technologies.
- Write validation protocols and reports supporting cleaning validation, equipment commissioning, qualification, and change management.
- Apply process, scientific, operational, and compliance knowledge and analytical troubleshooting to support delivery of new technologies into the plant.
- Handle quality records, including CCMS, CAPA, and deviations.
- Perform plant-floor runs and experiments, work with large-scale equipment, and analyze and summarize data findings.
- Define and document operating practices, ensure documentation accurately reflects operations performed, implement area improvements, commission equipment, design experiments, communicate findings, and participate in operations meetings.
- Work collaboratively to identify and implement appropriate corrective and preventive actions.
Benefits
- Retirement and Savings Plan with company contributions
- Medical, dental, and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program (or sales-based incentive plan for field sales representatives)
- Stock-based long-term incentives
- Time-off plans
- Flexible work models where possible
- Career development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
