Principal Scientist, Parenteral ExM MS&T
Core
Lead continuous process verification and operational excellence for parenteral drug manufacturing at Contract Manufacturing Organizations (CMOs) in North America.
Role type
Principal Scientist, Manufacturing Science & Technology (MS&T)
Builds
Parenteral drug products via CMO partners
Domain
Pharmaceutical manufacturing (sterile/parenteral) + Regulatory Compliance
Required skills
Sterile/parenteral manufacturing expertise, Root cause analysis (CAPA), Statistical process analysis (Minitab/JMP), Design of Experiments (DoE), Quality by Design (QbD), Risk assessment (pFMEA, Ishikawa), CMC documentation, FDA cGMP knowledge
Preferred skills
Master's or PhD in Chemical/Mechanical/Bioprocess Engineering/Biochemistry/Pharmacy/Microbiology, 4-12 years experience depending on degree
Technologies
Minitab, JMP, pFMEA, Ishikawa
Responsibilities
Drive CPV and OPEX initiatives at CMO sites, Serve as Site Implementation Lead for CMO partners, Lead investigations for out-of-specification results, Support regulatory/CMC activities and plant inspections, Lead change management for process deviations, Collaborate cross-functionally with QA, Supply Chain, and Product Development
Seniority
Principal, strategic technical leadership
