Director/Principal Scientist, Biologics Drug Substance Commercialization (BDSC)
Core
Senior leadership role driving late-stage and commercial biologics programs, focusing on upstream cell culture, process development, and commercialization.
Role type
Senior IC/Lead Biologics Process Scientist (Upstream)
Builds
Late-stage and commercial biologics drug substance for licensure and global supply
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Upstream cell culture process development, Biologics commercialization, Process characterization, Technology transfer, Scale-up, Regulatory compliance (cGMP), Cross-functional leadership, Team mentorship
Preferred skills
Multi-specific antibody therapeutics expertise, Process validation (PPQ), Regulatory submission authoring, Lean leadership principles, Analytical characterization
Technologies
Upstream unit operations, cGMP environments, Digital systems for manufacturing
Responsibilities
Lead upstream teams for late-stage and commercial programs, Provide technical leadership for lab and manufacturing scale studies, Support technology transfer to internal and external sites, Author regulatory documentation, Lead, coach, and mentor a team of scientists, Drive division-wide manufacturing and commercialization initiatives
Seniority
Director/Principal, hands-on IC with people management (via careerplan.io/jobs/R415281-1-directorprincipal-scientist-biologics-drug-substance-commercialization-bdsc-at-msd)
