Specialist Manufacturing Product Introduction; NPI):Downstream Readiness

Specialist Manufacturing New Product Introduction (NPI):
Downstream Readiness

In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. You will ensure new products are successfully introduced into the ANC facility, host cross‑functional meetings to drive timelines for the tech transfer of the program into the facility, and lead team improvement initiatives to drive improved productivity and scheduling accuracy.

• Lead and coordinate New Product Introduction (NPI) projects 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.

• Act as a technical expert, leading or participating 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.

• Own 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 toward continuous improvement in the plant, and track progress on a plant level.

• High school diploma / GED & 10 years of biotechnology operations experience OR
• Associate’s 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

• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
• Excellent cross‑functional project management, meeting facilitation, and technical writing skills.
• Experience in GMP manufacturing operations.
• Strong technical knowledge of drug substance processing in Cell Culture or Purification (chromatography, filtration, buffer compounding) and a 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 and/or cross‑train colleagues within core technical areas.
• Background in lean manufacturing methodologies and operational excellence.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
• Flexible work models, including remote work arrangements where possible.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities receive reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.