Director, Vaccines Drug Substance Commercialization - Upstream
Core
Lead the Upstream department for late-stage vaccine drug substance commercialization, providing technical process leadership and laboratory capabilities for process development, scale-up, and technology transfer to GMP sites.
Role type
Director, Upstream Process Development & Commercialization
Builds
Late-stage vaccine drug substance processes and commercial manufacturing commitments
Domain
Biopharmaceuticals / Vaccine Manufacturing
Required skills
Mammalian cell culture, Live-virus vaccine biology, Microbial fermentation, Bioreactor engineering, Process intensification, Scale-up, Process characterization, Technology transfer, Regulatory documentation (PPQ, comparability), Team leadership, Budget management
Preferred skills
Fed-batch and perfusion process development, High-throughput microbioreactors, Predictive modeling (MFA, omics), Computational Fluid Dynamics (CFD), Quality by Design (QbD), International regulatory filings (IND, MAA, BLA)
Technologies
AMBR, Stainless steel systems, Single use systems, Pilot-scale equipment, Commercial-scale manufacturing assets
Responsibilities
Provide senior technical authority for upstream vaccine process development; Drive process control and validation strategies for GMP sites; Direct development and scale-up across varied platforms; Align departmental goals with enterprise priorities; Manage team resources, capital, and consumable budgets; Provide expert technical guidance on large molecule products; Cultivate high-performance culture and develop talent; Evaluate team performance and establish succession plans; Champion EHS and safety compliance
Seniority
Director, Strategic Leadership & Team Management
