Position Summary:
- Principal Scientist, Upstream Process Sciences: Lead upstream process development, characterization, and scientific support for GMP manufacturing. Provide technical expertise for microbial/cell culture seed expansions and bioreactor operations across multiple cell lines; design and execute process development experiments for scalable clinical/commercial production.
Essential Functions:
- Lead/advise development of efficient upstream processes for whole cell products, viral vectors, recombinant monoclonal antibodies, Fc-fusions, and other proteins.
- Develop batch, fed-batch, and perfusion processes for inoculum expansion/biologics production.
- Manage daily team activities (hiring/training, coaching, performance monitoring).
- Coordinate process development, improvement, scale-up, and tech transfer.
- Advise on risk assessment, DOE, process characterization, validation, and monitoring.
- Collaborate with discovery, formulation, analytical, quality, regulatory, and manufacturing teams.
- Draft/review protocols, reports, and deviation investigations; present results to senior management.
- Author/review process-related regulatory submissions; create/edit/adopt SOPs; maintain lab equipment.
Education & Experience (Required):
- PhD + 6+ years, or MSc + 9+ years, or BS + 12+ years in biopharma process development and/or GMP upstream manufacturing; extensive experience in method development/validation/transfer.
- Previous supervisory experience strongly preferred.
Knowledge/Skills:
- Cell/molecular biology, immunology and/or virology; upstream biopharmaceutical process expertise; DOE/statistics; quality systems; strong communication and technical writing (SOPs, reports, validation/qualification documents for FDA/EMA). Downstream purification familiarity preferred.
Benefits (explicit):
- Medical/dental/vision; 401(k) match; PTO (11 holidays or unlimited for exempt, etc.); wellness programs; other listed programs.
Application:
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).