NPI Upstream Manufacturing Specialist — Remote Options
Amgen SA
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Benefits offered by this job
Job summary
Amgen North Carolina is seeking a Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness. The role interfaces between GMP manufacturing teams and Process Development to ensure successful tech transfer of new Drug Substance products.
The position is part of ANC’s Manufacturing Support team, hosting cross‑functional meetings to drive timelines, improve productivity and scheduling of new products within the biologics manufacturing facility.
Qualifications
- Biologics DS manufacturing background preferred.
- Strong cross‑functional PM and communication skills required.
- Experience in GMP manufacturing operations desirable.
- Ability to organize, analyze and interpret technical data.
Responsibilities
- Lead NPI with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality and others.
- Ensure production documents are accurate and up to date.
- Support troubleshooting, problem‑solving and RCAs; assist CAPA as needed.
- Own NPI Change Controls and respond to regulatory questions or audits.
- Facilitate Lean Transformation and OE initiatives to improve plant performance.
Skills
Education
Job description
Amgen North Carolina is seeking a Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness. The role interfaces between GMP manufacturing teams and Process Development to ensure successful tech transfer of new Drug Substance products.
The position is part of ANC’s Manufacturing Support team, hosting cross‑functional meetings to drive timelines, improve productivity and scheduling of new products within the biologics manufacturing facility.
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