Specialist Manufacturing New Product Introduction (NPI):Downstream Readiness
Amgen
August 16, 2026
Remote friendly (Holly Springs, NC)
United States
Operations
Specialist Manufacturing New Product Introduction (NPI): Downstream 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 scientific groups.
- Ensure new products are successfully introduced into ANC’s biologics manufacturing facility by hosting cross-functional meetings to drive timelines supporting tech transfer.
- 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 and Engineering, Quality, and other teams to introduce new Drug Substance products/technologies using project management tools.
- Act as a technical expert, leading or participating in projects and ensuring production documents are accurate and up to date.
- Support Manufacturing with troubleshooting, problem-solving, and RCAs; support CAPA development.
- Own NPI Change Controls; collaborate to drive on-time completion; respond to regulatory questions/audit findings.
- Champion Lean Transformation and operational excellence (OE) initiatives; facilitate continuous improvement and track progress.
Basic Qualifications:
- High school diploma/GED + 10 years biotechnology operations OR Associate’s + 8 years OR Bachelor’s + 4 years OR Master’s in chemistry/biology/engineering + 2 years OR Doctorate.
Preferred Qualifications:
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
- Cross-functional project management, meeting facilitation, technical writing.
- GMP manufacturing operations; drug substance processing knowledge (cell culture/purification: chromatography, filtration, buffer compounding).
- Ability to analyze/interpret technical data (trend analysis, forecasting, modeling).
- Communication of complex technical information; ability to coach/mentor.
- Background in lean manufacturing/OE.
What You Can Expect Of Us (Benefits):
- Retirement and Savings Plan, group medical/dental/vision, life/disability insurance, flexible spending accounts; discretionary bonus; stock-based long-term incentives; time-off and bi-annual shutdowns; flexible work models (remote where possible).
Apply instructions:
- Apply at 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 scientific groups.
- Ensure new products are successfully introduced into ANC’s biologics manufacturing facility by hosting cross-functional meetings to drive timelines supporting tech transfer.
- 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 and Engineering, Quality, and other teams to introduce new Drug Substance products/technologies using project management tools.
- Act as a technical expert, leading or participating in projects and ensuring production documents are accurate and up to date.
- Support Manufacturing with troubleshooting, problem-solving, and RCAs; support CAPA development.
- Own NPI Change Controls; collaborate to drive on-time completion; respond to regulatory questions/audit findings.
- Champion Lean Transformation and operational excellence (OE) initiatives; facilitate continuous improvement and track progress.
Basic Qualifications:
- High school diploma/GED + 10 years biotechnology operations OR Associate’s + 8 years OR Bachelor’s + 4 years OR Master’s in chemistry/biology/engineering + 2 years OR Doctorate.
Preferred Qualifications:
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
- Cross-functional project management, meeting facilitation, technical writing.
- GMP manufacturing operations; drug substance processing knowledge (cell culture/purification: chromatography, filtration, buffer compounding).
- Ability to analyze/interpret technical data (trend analysis, forecasting, modeling).
- Communication of complex technical information; ability to coach/mentor.
- Background in lean manufacturing/OE.
What You Can Expect Of Us (Benefits):
- Retirement and Savings Plan, group medical/dental/vision, life/disability insurance, flexible spending accounts; discretionary bonus; stock-based long-term incentives; time-off and bi-annual shutdowns; flexible work models (remote where possible).
Apply instructions:
- Apply at careers.amgen.com.