Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness

New Product Introduction (NPI)

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. Responsible for ensuring new products are successfully introduced into ANC’s biologics manufacturing facility. Host cross-functional meetings to drive timelines to support the tech transfer of the program into the facility.

• Coordinate with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and other teams to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools.
• Lead or participate in projects, ensuring that production documents are accurate and up to date.
• Support Manufacturing in troubleshooting, problem-solving, and RCAs.
• Support CAPA development to prevent error recurrence.
• Owes New Product Introduction (NPI) Change Controls and collaborate with stakeholders to drive on-time completion.
• Respond to regulatory questions and/or audit findings.
• Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant, and track progress on a plant level.

Qualifications

• High school diploma/GED & 10 years of biotechnology operations experience OR Associates degree & 8 years of biotechnology operations experience OR Bachelor’s degree and 4 years of biotechnology operations experience OR Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR Doctorate degree
• Experience in GMP manufacturing operations.
• Strong cross-functional project management, meeting facilitation, and technical writing skills.
• Technical knowledge of drug substance processing in Cell Culture or Purification (chromatography, filtration, buffer compounding).
• Broad understanding of related disciplinary areas in bioprocessing.
• Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc.
• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms.
• Ability to coach, mentor, or cross-train colleagues within core technical areas.
• Background in lean manufacturing methodologies and operational excellence.