NPI Downstream Lead, Biotech Manufacturing (Remote)
BioSpace
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Job summary
Amgen North Carolina Biologics Drug Substance Manufacturing plant is seeking a Specialist Manufacturing New Product Introduction (NPI): Downstream Readiness to drive successful tech transfers and NPI changes. You will lead cross-functional meetings with Manufacturing, Process Development, Supply Chain, Planning, Facilities, Engineering and Quality to introduce new drug substances into the facility.
The role emphasizes project management, accurate documentation, troubleshooting, RCAs, CAPA, and
Qualifications
- Biotech manufacturing operations experience required.
- Experience coordinating cross-functional teams in GMP environments.
- Strong documentation and technical writing skills.
- Lean/OE experience and continuous improvement mindset.
Responsibilities
- Lead NPI coordination with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality to introduce new Drug Substance products into the plant.
- Ensure production documents are accurate and up to date.
- Assist troubleshooting, problem-solving and RCAs; support CAPA development.
- Own NPI Change Controls and drive on-time completion; respond to regulatory questions.
- Champion Lean Transformation and OE initiatives to improve plant productivity and scheduling.
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Job description
Amgen North Carolina Biologics Drug Substance Manufacturing plant is seeking a Specialist Manufacturing New Product Introduction (NPI): Downstream Readiness to drive successful tech transfers and NPI changes. You will lead cross-functional meetings with Manufacturing, Process Development, Supply Chain, Planning, Facilities, Engineering and Quality to introduce new drug substances into the facility.
The role emphasizes project management, accurate documentation, troubleshooting, RCAs, CAPA, and
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