Specialist Manufacturing - Upstream DS
Amgen
June 27, 2026
On-site
Thousand Oaks, CA
Operations
Specialist Manufacturing Associate
Responsibilities:
- Support drug substance manufacturing upstream as process owner (PPO); provide subject-matter expertise.
- Lead cross-functional, complex projects using project management skills.
- Resolve quick issues and lead troubleshooting; execute function tests to troubleshoot/optimize process.
- Write protocols/reports for validation, function testing, equipment commissioning/qualification, and change management.
- Own quality records (e.g., CCMS, CAPA, CAPA-EV).
- Apply technical/process/scientific/operational and compliance knowledge to implement new technologies.
- Champion continual improvement; demonstrate strategic problem-solving.
- Present to inspectors on areas of expertise.
- Mentor and train junior staff.
- Be on-site (flexible worker); work various shifts as needed.
- Perform hands-on work in a clean room following GMP/SOPs with required PPE.
- Define/document operation practices; ensure documentation reflects operations; implement area improvements; support commissioning, DOE, communication, and operations meetings.
As Process Owner:
- Lead operational readiness for new technologies/equipment/processes.
- Assess and advise on process impact for changes.
- Develop/own drug substance manufacturing processes; draft/revise GMP documents (SOPs, forms); develop user requirements.
Basic Qualifications:
- Doctorate OR Master’s + 2 years; OR Bachelor’s + 4 years; OR Associate’s + 8 years; OR High school/GED + 10 years manufacturing/operations.
Preferred Qualifications:
- Degree in Engineering or Life Sciences; 3+ years in drug substance GMP technical support/manufacturing/engineering/process development.
- Technical knowledge of drug substance processing; ambiguity navigation; data-driven influence.
- Communicate complex technical info; coach/mentor; lead cross-functional teams; single-use technology knowledge.
- Data analysis/visualization; strong writing/presentation; Smartsheet/Excel, Trackwise, Visio, pi, SAP, Spotfire.
Benefits (Total Rewards Plan, if eligible):
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts, discretionary bonus (or sales incentive), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions:
- Apply via careers.amgen.com; no application deadline—applications accepted until sufficient candidates are received or selected.
Responsibilities:
- Support drug substance manufacturing upstream as process owner (PPO); provide subject-matter expertise.
- Lead cross-functional, complex projects using project management skills.
- Resolve quick issues and lead troubleshooting; execute function tests to troubleshoot/optimize process.
- Write protocols/reports for validation, function testing, equipment commissioning/qualification, and change management.
- Own quality records (e.g., CCMS, CAPA, CAPA-EV).
- Apply technical/process/scientific/operational and compliance knowledge to implement new technologies.
- Champion continual improvement; demonstrate strategic problem-solving.
- Present to inspectors on areas of expertise.
- Mentor and train junior staff.
- Be on-site (flexible worker); work various shifts as needed.
- Perform hands-on work in a clean room following GMP/SOPs with required PPE.
- Define/document operation practices; ensure documentation reflects operations; implement area improvements; support commissioning, DOE, communication, and operations meetings.
As Process Owner:
- Lead operational readiness for new technologies/equipment/processes.
- Assess and advise on process impact for changes.
- Develop/own drug substance manufacturing processes; draft/revise GMP documents (SOPs, forms); develop user requirements.
Basic Qualifications:
- Doctorate OR Master’s + 2 years; OR Bachelor’s + 4 years; OR Associate’s + 8 years; OR High school/GED + 10 years manufacturing/operations.
Preferred Qualifications:
- Degree in Engineering or Life Sciences; 3+ years in drug substance GMP technical support/manufacturing/engineering/process development.
- Technical knowledge of drug substance processing; ambiguity navigation; data-driven influence.
- Communicate complex technical info; coach/mentor; lead cross-functional teams; single-use technology knowledge.
- Data analysis/visualization; strong writing/presentation; Smartsheet/Excel, Trackwise, Visio, pi, SAP, Spotfire.
Benefits (Total Rewards Plan, if eligible):
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts, discretionary bonus (or sales incentive), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions:
- Apply via careers.amgen.com; no application deadline—applications accepted until sufficient candidates are received or selected.