Manager - New Product Introduction (NPI) and Manufacturing Execution System (MES)
Amgen
August 26, 2026
Remote friendly (Thousand Oaks, CA)
United States
Operations
Manager – New Product Introduction (NPI) and Manufacturing Execution System (MES)
Responsibilities:
- Directly manage Downstream NPI Specialists and MES Sr. Associates (NPI/new tech introduction; Electronic Batch Record (EBR) development and management), including hiring, training, oversight, performance evaluations, and development.
- Proactively assess team capabilities to meet evolving drug substance clinical/commercial supply needs.
- Lead downstream area team meetings and drive alignment in business processes.
- Coordinate with PD, DSTE, Supply Chain, Planning, Facilities & Engineering, Quality, MES network, and Manufacturing for new products, new/revised electronic batch records, and/or advanced technologies.
- Champion Lean Transformation/OE initiatives; facilitate continuous improvement and track plant-level progress.
- Partner with Regulatory and Quality on change control compliance and respond to regulatory questions/audit findings.
- Drive inspection readiness by keeping NPI/MES playbooks up to date and supporting audit/regulatory response strategy.
Basic Qualifications:
- Doctorate OR Master’s + 3 years biotech operations OR Bachelor’s + 5 years biotech operations OR Associate’s + 10 years biotech operations.
- Experience managing people and/or leading teams/projects/programs and resource allocation (may run concurrently).
Preferred Qualifications:
- Degree in Chemical Engineering/Industrial Engineering/Biology/Biochemistry.
- Leadership of direct reports.
- PAS X and/or Werum software.
- GMP operations experience (including NPI).
- Drug substance processing technical knowledge (cell culture, harvest, chromatography, filtration, buffer compounding).
- Technical data analysis (trend/forecasting/modeling).
- Communication in presentations and technical writing; coaching/mentoring.
- Lean and operational excellence background.
- Cross-functional project management experience.
Benefits (explicitly stated): Total Rewards Plan (eligible health/welfare, retirement savings with company contributions, bonus, stock-based incentives, time-off; flexible work where possible).
Application: Apply now; no application deadline (accepted until sufficient candidates or selection).
Responsibilities:
- Directly manage Downstream NPI Specialists and MES Sr. Associates (NPI/new tech introduction; Electronic Batch Record (EBR) development and management), including hiring, training, oversight, performance evaluations, and development.
- Proactively assess team capabilities to meet evolving drug substance clinical/commercial supply needs.
- Lead downstream area team meetings and drive alignment in business processes.
- Coordinate with PD, DSTE, Supply Chain, Planning, Facilities & Engineering, Quality, MES network, and Manufacturing for new products, new/revised electronic batch records, and/or advanced technologies.
- Champion Lean Transformation/OE initiatives; facilitate continuous improvement and track plant-level progress.
- Partner with Regulatory and Quality on change control compliance and respond to regulatory questions/audit findings.
- Drive inspection readiness by keeping NPI/MES playbooks up to date and supporting audit/regulatory response strategy.
Basic Qualifications:
- Doctorate OR Master’s + 3 years biotech operations OR Bachelor’s + 5 years biotech operations OR Associate’s + 10 years biotech operations.
- Experience managing people and/or leading teams/projects/programs and resource allocation (may run concurrently).
Preferred Qualifications:
- Degree in Chemical Engineering/Industrial Engineering/Biology/Biochemistry.
- Leadership of direct reports.
- PAS X and/or Werum software.
- GMP operations experience (including NPI).
- Drug substance processing technical knowledge (cell culture, harvest, chromatography, filtration, buffer compounding).
- Technical data analysis (trend/forecasting/modeling).
- Communication in presentations and technical writing; coaching/mentoring.
- Lean and operational excellence background.
- Cross-functional project management experience.
Benefits (explicitly stated): Total Rewards Plan (eligible health/welfare, retirement savings with company contributions, bonus, stock-based incentives, time-off; flexible work where possible).
Application: Apply now; no application deadline (accepted until sufficient candidates or selection).