Scientist, Process Development
Core
Lead cell culture process development and characterization for biologics (monoclonal antibodies, multi-specifics) to support pivotal trials and commercialization.
Role type
Senior IC process development scientist (cell culture)
Builds
Cell culture processes for biologics programs
Domain
Biopharmaceuticals / Cell culture
Required skills
Cell culture process development, Mammalian cell culture, Bioreactor scale-up, Media design, Statistical analysis, GMP documentation, Regulatory filings (BLA/MAA), Cross-functional collaboration
Preferred skills
PhD, FDA/EMA/ICH guidelines, CMC sections authoring, Pilot plant operation, Single use/stainless bioreactor systems
Technologies
Shake flasks, ambr15, ambr250, Bench-scale bioreactors, Pilot plant (up to 500 L)
Responsibilities
Optimize and characterize cell culture processes, Lead process risk assessment and PPQ support, Design experiments and perform hands-on cell culture operations, Author GMP/non-GMP technical documents and regulatory filings, Support technology transfer and pilot plant operations, Mentor junior group members
Seniority
Senior, hands-on IC with potential for management
