Principal Scientist, Upstream Process Development
Core
Lead cross-functional teams to develop CMC packages and upstream cell culture processes for biologics pipeline assets from first-in-human to commercial manufacturing.
Role type
Principal Scientist, Upstream Process Development
Builds
High yield, robust, and scalable cell culture processes for clinical and commercial manufacturing
Domain
Biologics / Biopharmaceuticals
Required skills
CHO fed-batch cell culture, bioreactor scale-up and tech transfer, DOE statistics, computational fluid dynamics (CFD), process characterization, regulatory filings, mentoring junior scientists
Preferred skills
Intensified inoculum and perfusion process development, high-throughput microbioreactor systems, media development and solution chemistry, data science approaches (MFA, omics, machine learning), cross-functional program leadership
Technologies
Bioreactors, Microbioreactors, CFD, FEA, PAT, Omics, Machine Learning
Responsibilities
Lead biologic upstream process development for first-in-human and commercial processes; Provide technical direction for process development, characterization, commercialization, and regulatory filing activities; Advance upstream platform process technical strategy and champion creative process improvement initiatives; Initiate new collaborations to assess new technologies and industry strategies; Collaborate with academia, industry partners, and vendors to drive development and innovation; Keep current with external patent and literature environment; Mentoring and educating junior scientists
Seniority
Principal, hands-on IC with strategy & mentorship
