Kunjan Desai

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.

Experience

1. Director - Cell Therapy Drug Product Process Development

   Sana Biotechnology, Inc.

   Aug 2023 — Present · 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)

  2002 — 2005

• University of Hertfordshire

  M.Sc. By research

  2005 — 2007

• University of Bedfordshire

  Doctor of Philosophy (Ph.D.)

  2009 — 2012