We have a current opportunity for a Sr. Principal Scientist, Process Development -Drug Substance with a leading Cell & Gene Therapy Biotech in the Bay Area. For further information about this position please apply.
- Development, implementation, characterization, and successful execution of robust, cutting-edge cell therapy manufacturing processes.
- Use Quality by Design principles to gain a thorough understanding of process/product relationships in order to define and implement robust, integrated control strategies.
- Support BLA and commercialization of allogenic therapies, including robust risk assessments and characterization plans.
- Create and optimize scale-down models for cell therapy manufacturing processes.
- Support clinical-scale non-GMP/GMP IND-enabling manufacturing operations, including Tech Transfer to CMO and successful GMP clinical material manufacturing.
- Contribute to Project Technical Teams, as well as effectively communicate and collaborate to ensure effective interactions with all stakeholder groups.
- Ensure high-quality, timely documentation in electronic laboratory notebooks
- Present data/strategies during Project Team meetings.
- Maintain your knowledge of process engineering and chemistry literature.
- Ph.D. in Chemical Engineering, Biochemistry, Molecular & Cell Biology, Immunology, (or a related field), +5 years or 7+ years (with M.S.) of relevant experience.
- Prior experience with Gene & Cell Therapy manufacturing is preferred.
- Background or strong familiarity of mammalian or primary cell culture, biochemistry, molecular and cell biology, and immunology.
- Extensive experience with upstream genetic modification and bioreactor/WAVE expansion, as well as downstream purification/separation, formulation/fill, and cryopreservation.
- Experience with media development, disposable processing technologies, and manufacturing process automation.
- Excellent understanding of reaction kinetics, reactor design, chemical thermodynamics, heat and mass transport, engineering statistics, modeling, and simulation.
- Experience in analytical methods such as multi-parametric flow cytometry-based assays for characterization/release/stability testing is preferred.