NPI Lead — Drug Product Manufacturing
Amgen
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Job summary
Amgen is seeking a Senior Associate Manufacturing for the Thousand Oaks DP facility (B20) to lead New Product Introduction efforts. You will coordinate between Manufacturing, Process Development, Supply Chain, QA and Facilities, owning project plans, timelines and documentation to ensure successful launches of clinical and commercial programs.
The role requires strong GMP knowledge, technical writing, and the ability to drive cross-functional teams toward Right-First-Time execution while
Qualifications
- Master’s degree in Engineering, Biology, Chemistry or Life Science Field OR Bachelor’s degree in Engineering, Biology, Chemistry or Life Science Field and 2 years of biotechnology operations experience OR Associate’s degree and 4 years of biotechnology operations experience OR High school diploma / GED and 6 years of biotechnology operations experience
Responsibilities
- Maintain an organized way of working with NPI support groups to develop, maintain, and implement the NPI project plan(s).
- Resolving issues in a timely manner and elevating cross-functional concerns to management.
- Own Change Controls in TrackWise ensuring records are compliant per GMP procedures.
- Own NPI record documents in CDOCS and lead cross-functional team meetings to execute NPI projects.
Skills
Education
Tools
Job description
Amgen is seeking a Senior Associate Manufacturing for the Thousand Oaks DP facility (B20) to lead New Product Introduction efforts. You will coordinate between Manufacturing, Process Development, Supply Chain, QA and Facilities, owning project plans, timelines and documentation to ensure successful launches of clinical and commercial programs.
The role requires strong GMP knowledge, technical writing, and the ability to drive cross-functional teams toward Right-First-Time execution while
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