Manufacturing Programs Senior Manager: New Product Introduction (NPI)
Amgen
August 08, 2026
Remote friendly (Holly Springs, NC)
United States
Operations
Manufacturing Programs Senior Manager: New Product Introduction (NPI)
Responsibilities:
- Coordinate as NPI subject matter expert with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and others to introduce new drug substance products and/or advanced technologies into the plant using project management tools.
- Provide rapid problem-solving for technical challenges.
- Lead a team of NPI manufacturing specialists and build a culture that helps staff thrive.
- Lead or participate in projects, ensuring production documents are accurate and up to date.
- Support Manufacturing in troubleshooting, problem-solving, and RCAs; support CAPA development to prevent error recurrence.
- Champion Lean Transformation and operational excellence (OE), facilitate continuous improvement, and track plant-level progress.
Basic Qualifications:
- Doctorate + 2 years biotechnology operations experience; or Master’s (chemistry/biology/engineering) + 6 years; or Bachelor’s + 8 years; or Associate’s + 10 years; or High school/GED + 12 years.
- Plus at least 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation.
Preferred Qualifications:
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
- Excellent cross-functional project management, meeting facilitation, and technical writing.
- GMP manufacturing operations experience.
- Technical knowledge of drug substance processing (cell culture or purification: chromatography, filtration, buffer compounding) and bioprocessing areas.
- Ability to analyze/interpret technical data (trend analysis, forecasting, modeling).
- Ability to communicate complex technical information in presentations and technical writing.
- Ability to coach/mentor and cross-train colleagues.
- Background in lean manufacturing and operational excellence.
Benefits (explicitly stated): comprehensive employee benefits (medical/dental/vision, life/disability, flexible spending), retirement/savings plan contributions, discretionary bonus (or sales incentive), stock-based long-term incentives, time-off with bi-annual shutdowns, flexible work models where possible.
Application: Apply at careers.amgen.com.
Responsibilities:
- Coordinate as NPI subject matter expert with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and others to introduce new drug substance products and/or advanced technologies into the plant using project management tools.
- Provide rapid problem-solving for technical challenges.
- Lead a team of NPI manufacturing specialists and build a culture that helps staff thrive.
- Lead or participate in projects, ensuring production documents are accurate and up to date.
- Support Manufacturing in troubleshooting, problem-solving, and RCAs; support CAPA development to prevent error recurrence.
- Champion Lean Transformation and operational excellence (OE), facilitate continuous improvement, and track plant-level progress.
Basic Qualifications:
- Doctorate + 2 years biotechnology operations experience; or Master’s (chemistry/biology/engineering) + 6 years; or Bachelor’s + 8 years; or Associate’s + 10 years; or High school/GED + 12 years.
- Plus at least 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation.
Preferred Qualifications:
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
- Excellent cross-functional project management, meeting facilitation, and technical writing.
- GMP manufacturing operations experience.
- Technical knowledge of drug substance processing (cell culture or purification: chromatography, filtration, buffer compounding) and bioprocessing areas.
- Ability to analyze/interpret technical data (trend analysis, forecasting, modeling).
- Ability to communicate complex technical information in presentations and technical writing.
- Ability to coach/mentor and cross-train colleagues.
- Background in lean manufacturing and operational excellence.
Benefits (explicitly stated): comprehensive employee benefits (medical/dental/vision, life/disability, flexible spending), retirement/savings plan contributions, discretionary bonus (or sales incentive), stock-based long-term incentives, time-off with bi-annual shutdowns, flexible work models where possible.
Application: Apply at careers.amgen.com.