Principal Scientist, Parenteral ExM MS&T
Core
Technical leader providing expert support and oversight for parenteral drug product manufacturing at Contract Manufacturing Organizations (CMOs) within North America.
Role type
Principal Scientist, Manufacturing Science & Technology (MS&T)
Builds
Parenteral drug products via CMO partners
Domain
Pharmaceutical manufacturing (sterile/parenteral)
Required skills
Sterile/parenteral manufacturing processes, FDA cGMP, Statistical process analysis (Minitab/JMP), Design of Experiments (DoE), Quality by Design (QbD), Risk Assessment (pFMEA, Ishikawa), Root cause analysis, CAPA development, CMC documentation
Preferred skills
Master's or PhD in Chemical/Mechanical/Bioprocess Engineering/Biochemistry/Pharmacy/Microbiology, Experience with sterile drug product manufacturing operations
Technologies
Minitab, JMP
Responsibilities
Drive continuous process verification (CPV) and Operational Excellence (OPEX) initiatives at CMO sites, Serve as the BMS Site Implementation Lead for CMO partners, Lead investigations and corrective/preventive action (CAPA) development, Support regulatory and CMC activities, Drive change management for complex process deviations, Represent MS&T on cross-functional project teams
Seniority
Principal, hands-on IC with strategic oversight