Specialist Manufacturing - Downstream DS
Amgen
June 27, 2026
On-site
Thousand Oaks, CA
Operations
Specialist Manufacturing Associate
Responsibilities:
- Support manufacturing by serving as process owner (PPO) for drug substance downstream.
- Lead cross-function and complex projects using project management skills.
- Resolve quick issues and lead troubleshooting; execute function tests to troubleshoot and optimize processes.
- Write protocols and reports for validation, function testing, equipment commissioning/qualification, and change management.
- Own quality records (CCMS, CAPA, CAPA-EV).
- Apply technical process/scientific/operational/compliance knowledge with analytical troubleshooting to implement new technologies.
- Champion continual improvement; present to inspectors on areas of expertise.
- Mentor and train junior staff.
- Work on-site (flexible worker) and be available for various shifts (days/swing/graves, weekends, holidays) per production schedule.
- Perform work in a clean room environment following GMP (SOPs) with required gowning/PPE.
As Process Owner:
- Lead operational readiness of new technologies, equipment, or processes.
- Assess and advise on process impact of changes.
- Develop/own drug substance manufacturing processes and procedures; draft/revise GMP documents (SOPs/forms) and user requirements for new technologies.
Basic Qualifications:
- Doctorate OR Master’s + 2 years manufacturing/operations OR Bachelor’s + 4 years OR Associate’s + 8 years OR HS/GED + 10 years.
Preferred Qualifications:
- Degree in Engineering or Life Sciences.
- 3+ years in drug substance GMP technical support, GMP manufacturing, engineering, or process development.
- Technical knowledge of drug substance processing; ability to work through ambiguity and lead milestones.
- Strong communication (presentations and technical writing), coaching/mentoring, cross-functional leadership, project leadership.
- Understanding of single-use technologies; data analysis/visualization; strong writing/presentation skills.
- Proficiency with Smartsheet/Excel, Trackwise, Visio, pi, SAP, Spotfire.
Benefits:
- Total Rewards Plan: health/welfare, retirement/savings, bonus/incentives (eligibility-based), stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions:
- Apply at careers.amgen.com. No application deadline; applications accepted until sufficient candidates are received or a candidate is selected. Sponsorship not guaranteed.
Responsibilities:
- Support manufacturing by serving as process owner (PPO) for drug substance downstream.
- Lead cross-function and complex projects using project management skills.
- Resolve quick issues and lead troubleshooting; execute function tests to troubleshoot and optimize processes.
- Write protocols and reports for validation, function testing, equipment commissioning/qualification, and change management.
- Own quality records (CCMS, CAPA, CAPA-EV).
- Apply technical process/scientific/operational/compliance knowledge with analytical troubleshooting to implement new technologies.
- Champion continual improvement; present to inspectors on areas of expertise.
- Mentor and train junior staff.
- Work on-site (flexible worker) and be available for various shifts (days/swing/graves, weekends, holidays) per production schedule.
- Perform work in a clean room environment following GMP (SOPs) with required gowning/PPE.
As Process Owner:
- Lead operational readiness of new technologies, equipment, or processes.
- Assess and advise on process impact of changes.
- Develop/own drug substance manufacturing processes and procedures; draft/revise GMP documents (SOPs/forms) and user requirements for new technologies.
Basic Qualifications:
- Doctorate OR Master’s + 2 years manufacturing/operations OR Bachelor’s + 4 years OR Associate’s + 8 years OR HS/GED + 10 years.
Preferred Qualifications:
- Degree in Engineering or Life Sciences.
- 3+ years in drug substance GMP technical support, GMP manufacturing, engineering, or process development.
- Technical knowledge of drug substance processing; ability to work through ambiguity and lead milestones.
- Strong communication (presentations and technical writing), coaching/mentoring, cross-functional leadership, project leadership.
- Understanding of single-use technologies; data analysis/visualization; strong writing/presentation skills.
- Proficiency with Smartsheet/Excel, Trackwise, Visio, pi, SAP, Spotfire.
Benefits:
- Total Rewards Plan: health/welfare, retirement/savings, bonus/incentives (eligibility-based), stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions:
- Apply at careers.amgen.com. No application deadline; applications accepted until sufficient candidates are received or a candidate is selected. Sponsorship not guaranteed.