Associate Manufacturing
Amgen
June 27, 2026
On-site
Thousand Oaks, CA
Operations
Associate Manufacturing
What You Will Do
- Work onsite in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant, supporting development, clinical, and launch activities.
- Perform manufacturing operations within Building 23 per SOPs.
- Hands-on operations 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/revise routine documents (MPs, SOPs, technical reports).
- Initiate and own quality records (CAPA, CAPA-EV).
- Identify/recommend improvements and implement approved changes.
- Basic troubleshooting; recognize and report problems.
- Direct operators on critical processes.
- Assist with documentation review (area audits, batch records).
- Train staff on hands-on tasks; serve as safety representative as needed.
- Participate on cross-functional teams and support implementation of new technologies.
Work Environment
- Must be able to work in a clean room with full gowning and GMP adherence.
- Must work various shifts (day/swing/graves, weekends/holidays) as scheduled.
Basic Qualifications
- High school/GED + 2 years manufacturing/operations, or Associate degree + 6 months, or Bachelor’s degree.
Preferred Qualifications
- Bachelor’s in science/engineering; large-scale biotech (purification/cell culture/aseptic); single-use systems; CFR/regulatory knowledge; mechanical aptitude; basic stats/math; interpret/apply GMP; analytical methods; technical writing; project management/presentation; troubleshooting; Delta V; lab equipment/testing.
Application Instructions
- Apply now. No application deadline; continue accepting applications until sufficient candidates are received or a candidate is selected.
What You Will Do
- Work onsite in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant, supporting development, clinical, and launch activities.
- Perform manufacturing operations within Building 23 per SOPs.
- Hands-on operations 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/revise routine documents (MPs, SOPs, technical reports).
- Initiate and own quality records (CAPA, CAPA-EV).
- Identify/recommend improvements and implement approved changes.
- Basic troubleshooting; recognize and report problems.
- Direct operators on critical processes.
- Assist with documentation review (area audits, batch records).
- Train staff on hands-on tasks; serve as safety representative as needed.
- Participate on cross-functional teams and support implementation of new technologies.
Work Environment
- Must be able to work in a clean room with full gowning and GMP adherence.
- Must work various shifts (day/swing/graves, weekends/holidays) as scheduled.
Basic Qualifications
- High school/GED + 2 years manufacturing/operations, or Associate degree + 6 months, or Bachelor’s degree.
Preferred Qualifications
- Bachelor’s in science/engineering; large-scale biotech (purification/cell culture/aseptic); single-use systems; CFR/regulatory knowledge; mechanical aptitude; basic stats/math; interpret/apply GMP; analytical methods; technical writing; project management/presentation; troubleshooting; Delta V; lab equipment/testing.
Application Instructions
- Apply now. No application deadline; continue accepting applications until sufficient candidates are received or a candidate is selected.