Associate Manufacturing
Amgen
Associate Manufacturing
What You Will Do
- Work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and launch activities.
- Perform manufacturing operations in Building 23 in accordance with SOPs.
- Conduct hands-on manufacturing including setup, cleaning, sanitization, media/buffer preparation, and analytical testing.
Key Responsibilities
- Perform and monitor critical manufacturing processes.
- Execute routine validation protocols.
- Comply with GMP requirements and safety/compliance expectations.
- Draft and revise routine documents (MPs, SOPs, technical reports).
- Initiate and own quality records (CAPA and CAPA-EV).
- Identify and recommend improvements; implement approved changes.
- Perform basic troubleshooting and accurately recognize/report problems.
- Direct operators on critical processes.
- Assist with documentation review (area audits, batch records).
- Train staff on hands-on tasks as needed.
- Serve as a safety representative as needed.
- Participate on cross-functional teams; apply technical/scientific/operational knowledge to implement new technologies.
- Champion continuous improvement.
Work Environment
- Must be available onsite; work in a clean room (full gowning, steel-toe shoes, gloves, hairnet).
- Must be able to work various shifts (days/swing/graves, weekends/holidays).
Basic Qualifications
- High school diploma/GED + 2 years manufacturing/operations OR Associate degree + 6 months OR Bachelorโs degree.
Preferred Qualifications
- Bachelorโs in science/engineering; knowledge of large-scale biotech operations (purification, cell culture, aseptic processing); single-use systems; CFR/regulatory; mechanical aptitude; basic stats/math; ability to interpret/apply GMP; understanding analytical methods; technical writing; project management/presentation; troubleshooting; Delta V; lab equipment/testing.
Benefits (if applicable)
- Total Rewards Plan with eligible health/welfare plans, retirement savings contributions, bonus, stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com; no application deadline (applications accepted until sufficient number/selection).