Manufacturing Programs Senior Manager: New Product Introduction (NPI)
Amgen
August 30, 2026
Remote friendly (Holly Springs, NC)
United States
Operations
Manufacturing Programs Senior Manager: New Product Introduction (NPI)
Responsibilities:
- Serve as NPI subject matter expert coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and others to introduce new Drug Substance products/advanced technologies 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/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 recurrence.
- Champion Lean Transformation and Operational Excellence (OE); facilitate continuous improvement and track progress at the plant level.
Qualifications:
Basic Qualifications:
- Doctorate degree and 2 years of biotechnology operations experience, OR Master’s degree (chemistry, biology, or engineering) and 6 years, OR Bachelor’s degree and 8 years, OR Associate’s degree and 10 years, OR High school diploma/GED and 12 years.
- Plus: minimum 2 years experience directly managing people and/or leading teams/projects/programs or directing resource allocation (may run concurrently with required technical experience).
Preferred Qualifications:
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
- Cross-functional project management, meeting facilitation, and technical writing skills.
- GMP manufacturing experience.
- Technical knowledge of drug substance processing (cell culture and/or purification: chromatography, filtration, buffer compounding).
- Ability to analyze/interprete technical data (trend analysis, forecasting, modeling).
- Ability to communicate complex technical information in presentations and writing.
- Ability to coach/mentor/cross-train; background in lean manufacturing and operational excellence.
Benefits:
- Retirement and Savings Plan (company contributions), group medical/dental/vision, life and disability insurance, flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales reps); stock-based long-term incentives.
- Award-winning time-off plans, bi-annual company-wide shutdowns.
- Flexible work models, including remote work where possible.
Apply now: careers.amgen.com
Responsibilities:
- Serve as NPI subject matter expert coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and others to introduce new Drug Substance products/advanced technologies 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/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 recurrence.
- Champion Lean Transformation and Operational Excellence (OE); facilitate continuous improvement and track progress at the plant level.
Qualifications:
Basic Qualifications:
- Doctorate degree and 2 years of biotechnology operations experience, OR Master’s degree (chemistry, biology, or engineering) and 6 years, OR Bachelor’s degree and 8 years, OR Associate’s degree and 10 years, OR High school diploma/GED and 12 years.
- Plus: minimum 2 years experience directly managing people and/or leading teams/projects/programs or directing resource allocation (may run concurrently with required technical experience).
Preferred Qualifications:
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
- Cross-functional project management, meeting facilitation, and technical writing skills.
- GMP manufacturing experience.
- Technical knowledge of drug substance processing (cell culture and/or purification: chromatography, filtration, buffer compounding).
- Ability to analyze/interprete technical data (trend analysis, forecasting, modeling).
- Ability to communicate complex technical information in presentations and writing.
- Ability to coach/mentor/cross-train; background in lean manufacturing and operational excellence.
Benefits:
- Retirement and Savings Plan (company contributions), group medical/dental/vision, life and disability insurance, flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales reps); stock-based long-term incentives.
- Award-winning time-off plans, bi-annual company-wide shutdowns.
- Flexible work models, including remote work where possible.
Apply now: careers.amgen.com