Principal Scientist, Upstream Development
Core
Leading biologic upstream process development for first-in-human and commercial processes, developing high yield, robust, and scalable cell culture processes for biotherapeutics.
Role type
Principal Scientist, Upstream Development (Biologics Process R&D)
Builds
Cell culture processes for clinical trials and commercial manufacturing of biologics
Domain
Biopharmaceuticals / Upstream Bioprocessing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CHO fed-batch cell culture, cell culture bioreactors (micro, bench, pilot), scaleup/tech transfer, cell culture media, CHO cell biology and metabolism, DOE statistics, computational fluid dynamics (CFD), biologics CMC development cycle, process characterization, regulatory filing strategy
Preferred skills
intensified inoculum and perfusion process development, technology transfer, scale-down model qualification, high throughput microbioreactor systems, in situ analytics, media/solution chemistry, metabolic flux analysis (MFA), omics, machine learning, PAT integration
Technologies
CFD, MFA, omics, machine learning, PAT, microbioreactors, bioreactors
Responsibilities
Lead upstream process development for early- and late-stage assets; provide technical direction for process development, characterization, commercialization, and regulatory filings; advance upstream platform process technical strategy; initiate collaborations with academia and industry for new technologies; supervise and coach junior scientists; maintain external scientific presence through publications and patents
Seniority
Principal, hands-on IC with strategic leadership and mentoring
