Specialist Manufacturing New Product Introduction (NPI):Downstream Readiness

Amgen · Holly Springs, NC

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Role summary

This specialist role coordinates new product introductions into Amgen's biologics drug substance manufacturing facility in North Carolina. Responsibilities include leading cross-functional teams through tech transfer projects, managing change controls, supporting troubleshooting efforts, and driving continuous improvement initiatives. The position requires biologics manufacturing experience and strong project management and communication skills.

What they're looking for

Biologics drug substance manufacturing background with cross-functional project management skills
High school diploma/GED plus 10 years biotechnology operations experience, or equivalent education/experience combination
GMP manufacturing operations experience
Technical knowledge of drug substance processing in cell culture or purification technologies
Ability to organize, analyze, and interpret technical data through trend analysis and modeling
Lean manufacturing methodologies and operational excellence background
Excellent cross-functional communication and technical writing skills

What you'll be doing

Lead NPI coordination across manufacturing, process development, supply chain, planning, and quality teams
Drive cross-functional meetings to support technology transfer timelines into the biologics facility
Ensure production documents are accurate and maintain technical accuracy through project participation
Support manufacturing troubleshooting, problem-solving, and CAPA development to prevent errors
Champion lean transformation and operational excellence initiatives to drive continuous improvement

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Date posted30 days ago

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