Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions)
Core
Support New Product Introduction (NPI) programs by coordinating cross-functional activities to ensure compliant and timely implementation of drug substance manufacturing processes.
Role type
Senior Associate Manufacturing (NPI Systems)
Builds
Drug substance manufacturing processes and systems at a biologics plant
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing experience, cross-functional coordination, Quality Risk Assessment facilitation, Change Control management, Bill of Materials creation, technical writing, structured problem-solving
Preferred skills
GMP biotechnology/pharmaceutical manufacturing experience, Quality Management Systems (Veeva QMS/TrackWise), Process Development knowledge, MES familiarity, project coordination
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/post-implementation tasks and verify documentation; Maintain readiness trackers and provide status updates
Seniority
Senior, hands-on IC
