Kunjan Desai
Director - Cell Therapy Drug Product Process Development @Sana Biotechnology, Inc.
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WORK HISTORY
Director - Cell Therapy Drug Product Process Development @Sana Biotechnology, Inc.
South San Francisco, CA, US
Technical and Leadership Expertise: • Lead CART cell therapy drug product process development group that focus on drug substance production, drug product formulation, aseptic fill/finish, cryopreservation, storage, and stability assessment • Champion risk management by developing end-to-end FMEA/risk-based processes. • Bridge development phases by performing gap assessments and establishing Phase appropriate processes early to pivotal stages of development. CMC and Regulatory Strategy Developent: • Contribute to regulatory strategy and activities by authoring and reviewing CMC documentation for regulatory filings. • Actively participate in the core CMC team, focusing on comparability strategies for pivotal development. • Lead cross-functional CMC teams to ensure the successful development and execution of CMC plans and strategies for assigned projects. Communication and Project Management: • Serve as a project core team member, effectively communicating CMC strategies and project status to cross -functional stakeholders to drive informed decision-making. • Foster collaboration with process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox teams to achieve shared CMC and program goals.
EDUCATION
Bangalore University
Bachelor of Science (BSc)
University of Hertfordshire
M.Sc. By research
University of Bedfordshire
Doctor of Philosophy (Ph.D.)
ABOUT KUNJAN DESAI
Experienced Cell/Gene Therapy Process Development Leader • Core Expertise: CMC development, early to late-phase process development, and technology transfer of a diverse range of cellular products, including T cells, NK cells, iPSCs, and MSCs. Expertise in both non-viral and viral modified cell therapies for early-phase clinical trials. • Regulatory Proficiency: In-depth knowledge and experience in regulatory filings, such as INDs (primarily CMC), comparability protocols, and various Type meeting packages (e.g, Type D). Experienced in global filings, including APAC and EU. • Regulatory Compliance: Strong understanding of regulatory guidelines governing cell therapy manufacturing, including ISO, cGMP, 21 CFR 1271, and Q7/Q8. • GMP Manufacturing Experience: Proven track record working in Class cGMP facilities, authoring and reviewing cGMP documentation, and executing validation runs. • Technology Transfer: Successful transfer of processes into GMP manufacturing environments. Expertise in process development, including scaling up, scaling down model development, characterization, and optimization of cryopreservation protocols. • Cell Therapy Process Development: Extensive experience in cell therapy process development, encompassing both upstream (at clinical scale) and downstream processes, such as formulation, cryopreservation (freezing and thawing), and fill-finish development.
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