Position Summary
Principal Scientist, Upstream Process Sciences: Manage upstream process development, process characterization, and scientific support for GMP manufacturing. Serve as technical expert for unit operations including microbial and cell culture seed expansions and bioreactor operations across multiple cell lines. Design and execute process development experiments to create robust, scalable clinical and commercial production.
Responsibilities
- Lead/advise microbial and cell culture production for whole cell products, viral vector, recombinant monoclonal antibodies, Fc-fusion, and other proteins.
- Develop batch, fed-batch, and perfusion processes for inoculum expansion and biologics production.
- Manage day-to-day team activities (hiring, training, coaching, performance monitoring).
- Coordinate and provide expertise in process development, improvement, scale-up, and tech transfer.
- Advise on risk assessment, DOE, process characterization, process validation, and monitoring.
- Collaborate with discovery, formulation, analytical, quality, regulatory, and manufacturing teams.
- Draft/review/approve technical protocols, reports, and manufacturing deviation investigations.
- Present results to interdepartmental teams and senior management; author/review process-related regulatory submissions.
Qualifications
- Ph.D. with 6+ years (or MSc with 9+ years, or BS with 12+ years) in biopharmaceutical process development and/or GMP manufacturing with direct upstream experience.
- Previous supervisory experience strongly preferred.
Skills
- Knowledge of cell/molecular biology, immunology, and/or virology.
- Expertise in upstream biopharmaceutical production; in-depth DOE/statistics; microbial/cell culture/harvest operations affecting quality.
- Quality systems knowledge; excellent written/verbal communication and strong technical writing for SOPs and validation/qualification/filing support.
- Familiarity with downstream purification; ability to adapt to changing priorities.
Benefits (eligible)
- Discretionary bonus and equity award.
- Medical, Dental, Vision; wellness programs; EAP; life/AD&D, disability; FSAs; 401(k) match; PTO and related time off; other listed benefits.
Application instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).