Principal Scientist, Upstream Process, Process Development
$146,410–$192,164 year
On-site · Somerset, New Jersey, United States
Job Summary
Principal Scientist, Lentivirus Upstream Process Development based in Somerset, NJ leads design, optimization, and scale-up of upstream production for lentiviral vectors (LVV) to support LVV generation and early-cell-therapy programs. Responsibilities include designing upstream production strategies, optimizing seed trains and mammalian cell culture (HEK293/HEK293T), transient transfection, and bioreactor operations; establishing scale-up/scale-down models; translating bench workflows to GMP manufacturing with tech transfer and troubleshooting during clinical runs; leading study protocols, parameter optimization, and knowledge management; cross-functional collaboration with CMC, regulatory, downstream, and analytical teams; authoring technical documents and contributing to regulatory submissions; ensuring regulatory compliance and driving continuous improvement. Key skills include GMP-aware process development for viral vectors, bioreactor operation at multiple scales, data-driven optimization, project leadership, and strong scientific communication.
Required Qualifications
- Advanced degree (PhD preferred, or MS) in Chemical Engineering, Biomedical Engineering, Virology, Molecular Biology, or related field
- 8+ years (PhD) or 10+ years (MS) of experience in process development or manufacturing within biotech/pharma
- Hands-on experience in mammalian cell culture (HEK293, HEK293T), seed train expansion, feeding strategy, and transient transfection optimization for viral vectors
- Proven expertise in bioreactor scale-up/scale-down models
- Strong understanding of GMP manufacturing requirements and CMC strategies for early-phase clinical trials
- Strong knowledge of cell and lentiviral vector technologies; engineering modeling, mass transfer, and bioprocess optimization
- Excellent leadership and communication skills; ability to manage timelines and collaborate across teams
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