Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions)
Core
Support New Product Introduction (NPI) programs by coordinating cross-functional activities, managing Quality Risk Assessments, and maintaining compliant documentation for drug substance manufacturing.
Role type
Senior Associate Manufacturing (NPI Systems)
Builds
Drug substance manufacturing processes and systems at the Amgen FleX Batch facility
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
GMP manufacturing experience, cross-functional coordination, Quality Risk Assessment facilitation, Change Control management, Bill of Materials creation, technical writing, project tracking
Preferred skills
Science/Engineering degree, GMP biotech/pharma experience, QMS tools (Veeva QMS, TrackWise), MES knowledge, stakeholder management
Technologies
Veeva QMS, TrackWise, MES
Responsibilities
Facilitate cross-functional Quality Risk Assessments (QRAs) and document decisions; Prepare and maintain QRA reports, FMEAs, and risk action logs; Create and maintain process Bills of Materials (BOMs); Own assigned NPI Change Control records and manage lifecycle phases; Track pre-implementation, implementation, and post-implementation tasks and deliverables; Maintain trackers and provide routine status updates to management.
Seniority
Senior, hands-on IC