Principal Scientist, Drug Substance Process Development & Manufacturing (mAB development focus)
Core
Lead drug substance process development and GMP manufacturing for monoclonal antibodies, bridging scale-up, tech transfer, and CDMO execution.
Role type
Principal Scientist, Drug Substance Process Development & Manufacturing
Builds
Monoclonal antibody drug substance for clinical programs
Domain
Biologics manufacturing / CDMO / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Monoclonal antibody process development, Upstream expression, Purification (UF/DF), Viral clearance, Scale-up studies, Process characterization, Tech transfer, GMP documentation, Quality systems (deviations/CAPA), Cross-functional collaboration, Data-driven troubleshooting
Preferred skills
BLA/IND submission support, Accelerated development environments, AI-driven knowledge management tools
Technologies
AI-driven tools for data analysis
Responsibilities
Support drug substance process development and manufacturing activities, Design and execute scale-up and process characterization studies, Own tech transfer and support GMP campaigns at CDMOs, Review and author GMP documentation, Provide technical leadership for GMP manufacturing, Partner cross-functionally to drive program execution, Drive continuous process improvement initiatives
Seniority
Principal, hands-on IC with strategic oversight
