Principal Scientist, Process Sciences
$155,000–$180,000 year
On-siteSouth San Francisco, California, United States
Job Summary
Lead the Pilot Plant team, overseeing execution of large-scale and engineering runs in support of process development, characterization, and technology transfer. Translate process development strategies into robust, executable at-scale cell therapy manufacturing operations and ensure alignment across development, pilot, and manufacturing functions. Design and execute high-impact process development studies using QbD principles while applying engineering principles to support process understanding and scale-up. Drive end-to-end process integration, including thaw, activation, genetic engineering, cell expansion, and fill/finish unit operations, and develop closed, aseptic, automation strategies. Serve as the primary interface with Drug Product, Manufacturing, and MSAT functions, authoring technical reports and contributing to regulatory filings. Act as a technical mentor, coaching scientists on study design and data interpretation, and interpret complex datasets to communicate results to senior leadership.
Required Qualifications
- Ph.D in Chemical Engineering, Bioengineering, Biochemistry, Molecular & Cell Biology, Immunology or related field with at least 7 years of relevant experience
- MS with at least 10 years of industry experience
- BS with at least 12 years of industry experience
- Extensive experience in process development and scale-up for biologics or cell therapy manufacturing
- Demonstrated expertise in process characterization, DOE, and data-driven decision making
- Experience using Python or R for analysis of complex datasets and development of automation solutions for cell therapy manufacturing platforms
- Strong understanding of cell therapy manufacturing processes (i.e. gene editing, viral transduction, cell expansion, formulation)
- Experience supporting regulatory filings (IND/BLA) and process validation (PPQ)
- Proven track record of leading complex technical programs and cross-functional initiatives
- Strong leadership, mentorship, and cross-functional collaboration skills
- Strong written and verbal communication skills, including authoring technical documents and presenting to senior leadership
- Candidates must be authorized to work in the U.S.
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