Principal Scientist, Parenteral ExM MS&T
Core
Technical leader overseeing parenteral drug product manufacturing at Contract Manufacturing Organizations (CMOs) in North America, driving process verification, operational excellence, and regulatory compliance.
Role type
Principal Scientist (Manufacturing Science & Technology)
Builds
Sterile drug product supply chain and manufacturing processes at CMO sites
Domain
Pharmaceutical manufacturing (Parenteral/Sterile)
Required skills
Sterile/parenteral manufacturing expertise, FDA cGMP knowledge, Statistical process analysis (Minitab/JMP), Risk assessment (pFMEA, Ishikawa), Root cause analysis, CAPA development, Change management
Preferred skills
Master's or PhD in Chemical/Mechanical/Bioprocess Engineering/Biochemistry/Pharmacy/Microbiology, Experience with Design of Experiments (DoE) and Quality by Design (QbD)
Technologies
Minitab, JMP
Responsibilities
Drive continuous process verification (CPV) and Operational Excellence (OPEX) initiatives at CMO sites; Serve as Site Implementation Lead for CMO partners including Person in Plant (PIP) support; Lead root cause analysis and CAPA development for manufacturing deviations; Contribute technical input to CMC documents and support regulatory inspections; Coordinate complex change requests across multiple sites; Represent MS&T on cross-functional project teams
Seniority
Principal, strategic technical leadership with hands-on oversight