Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness
Amgen
August 15, 2026
Remote friendly (Holly Springs, NC)
United States
Operations
Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness
What You Will Do
Communicate and interface between GMP manufacturing teams at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development groups. Ensure new products are successfully introduced into ANC biologics manufacturing. Host cross-functional meetings to drive timelines for tech transfer into the facility. Propose, participate in, and lead team improvement initiatives to improve productivity and scheduling accuracy.
Responsibilities
- Lead NPI coordination with Manufacturing, Process Development, Supply Chain, Planning, Facilities & Engineering, Quality, and others to introduce new drug substance products/advanced technologies using project management tools.
- Technical expert leading/participating in projects; ensure production documents are accurate and up to date.
- Support Manufacturing with troubleshooting, problem-solving, and RCAs; support CAPA development to prevent recurrence.
- Own NPI Change Controls; collaborate to ensure on-time completion; respond to regulatory questions and/or audit findings.
- Champion Lean Transformation and Operational Excellence initiatives; facilitate continuous improvement and track progress.
Basic Qualifications
- High school diploma/GED + 10 years biotechnology operations experience OR
- Associate’s degree + 8 years OR
- Bachelor’s degree + 4 years OR
- Master’s degree (chemistry, biology, or engineering) + 2 years OR
- Doctorate degree.
Preferred Qualifications
- Degree in Chemical/Industrial Engineering, Biology, or Biochemistry.
- 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 related bioprocessing areas.
- Ability to analyze/interprete technical data (trend analysis, forecasting, modeling).
- Ability to communicate complex technical information in presentations and technical writing.
- Ability to coach/mentor/cross-train.
- Background in lean manufacturing and operational excellence.
Benefits (as stated)
- Health & welfare benefits, retirement/savings with company contributions, bonus program, stock-based long-term incentives, time-off plans/bi-annual shutdowns, and flexible work models (remote where possible).
Application instructions
- Apply now via careers.amgen.com.
What You Will Do
Communicate and interface between GMP manufacturing teams at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development groups. Ensure new products are successfully introduced into ANC biologics manufacturing. Host cross-functional meetings to drive timelines for tech transfer into the facility. Propose, participate in, and lead team improvement initiatives to improve productivity and scheduling accuracy.
Responsibilities
- Lead NPI coordination with Manufacturing, Process Development, Supply Chain, Planning, Facilities & Engineering, Quality, and others to introduce new drug substance products/advanced technologies using project management tools.
- Technical expert leading/participating in projects; ensure production documents are accurate and up to date.
- Support Manufacturing with troubleshooting, problem-solving, and RCAs; support CAPA development to prevent recurrence.
- Own NPI Change Controls; collaborate to ensure on-time completion; respond to regulatory questions and/or audit findings.
- Champion Lean Transformation and Operational Excellence initiatives; facilitate continuous improvement and track progress.
Basic Qualifications
- High school diploma/GED + 10 years biotechnology operations experience OR
- Associate’s degree + 8 years OR
- Bachelor’s degree + 4 years OR
- Master’s degree (chemistry, biology, or engineering) + 2 years OR
- Doctorate degree.
Preferred Qualifications
- Degree in Chemical/Industrial Engineering, Biology, or Biochemistry.
- 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 related bioprocessing areas.
- Ability to analyze/interprete technical data (trend analysis, forecasting, modeling).
- Ability to communicate complex technical information in presentations and technical writing.
- Ability to coach/mentor/cross-train.
- Background in lean manufacturing and operational excellence.
Benefits (as stated)
- Health & welfare benefits, retirement/savings with company contributions, bonus program, stock-based long-term incentives, time-off plans/bi-annual shutdowns, and flexible work models (remote where possible).
Application instructions
- Apply now via careers.amgen.com.