Principal Scientist, Upstream Process Development
Core
Lead cross-functional teams to develop CMC packages, upstream cell culture processes, and technical strategies for biologics pipeline assets from early to late-stage clinical development.
Role type
Principal Scientist, Upstream Process Development
Builds
High-yield, robust, and scalable cell culture processes for clinical trials and commercial manufacturing
Domain
Biologics / Pharmaceutical Process Development
Deliverable
production ML models | product features
Required skills
Upstream process development, CHO fed-batch cell culture, Bioreactor operations (micro/pilot-scale), Scale-up and tech transfer, DOE statistics, Computational fluid dynamics (CFD), CMC development cycle, Process characterization, Late-stage commercial process development, Staff mentoring
Preferred skills
Intensified inoculum and perfusion process development, High-throughput microbioreactor systems, In situ analytics, Media development and solution chemistry, Data science (metabolic flux analysis, omics, machine learning), Cross-functional program leadership
Technologies
Bioreactors, Microbioreactors, CFD, PAT, Machine Learning, Omics
Responsibilities
Lead biologic upstream process development for first-in-human and commercial processes; Provide technical direction for process development, characterization, commercialization, and regulatory filings; Advance upstream platform process technical strategy; Initiate collaborations with academia, industry partners, and vendors; Keep current with external patent and literature environment; Mentor and educate junior scientists
Seniority
Principal, hands-on IC with strategic leadership
