Sr Scientist, Process Development
Core
Lead cell culture process development and characterization for biologics (monoclonal antibodies, multi-specifics, novel modalities) to support pivotal trials and commercialization.
Role type
Senior Scientist, Process Development (Pivotal & Commercial)
Builds
Cell culture processes for biologics programs
Domain
Biopharmaceuticals / Cell Culture
Required skills
Cell culture process optimization, GMP documentation, technology transfer, experimental design, statistical analysis, team management, regulatory submission support
Preferred skills
Ph.D. with industry experience, GMP facility leadership, high-throughput bioreactor operations, media development, design-of-experiments, lab automation
Technologies
Shake flasks, ambr15, ambr250, bench-scale bioreactors, 500 L single-use bioreactors, JMP, Spotfire
Responsibilities
Optimize and characterize cell culture processes for pivotal trials and commercialization; Lead process risk assessment and BLA preparation; Support technology transfer with global MSAT group; Design and perform hands-on cell culture operations; Manage direct and indirect reports; Author GMP and non-GMP technical documents
Seniority
Senior, hands-on IC with people leadership