Ajit Kamath

About Ajit Kamath

I am an experienced Analytical Development leader skilled in developing analytical strategy and analytics for transformative cell and gene therapies including CAR-T therapies and heme malignancies to solve unmet needs. I aim to use my broad experience in analytics including QbD and CMC to deliver phase appropriate analytics and enable the development of safe and effective therapeutics. 8+ years of experience in GxP Analytical Development to facilitate QC and regulatory requirement. 15+ years of research experience in Immunology, symbiosis, pathogenesis, and Biochemistry. 8+ years of experience designing novel molecular and cellular assays to address research questions. Effective written and oral communication skills as evidenced by 5 publications and 7+ conference presentations Known for high efficiency and have a proven track record of advancing multiple projects simultaneously

Experience

1. Associate Director Analytical Development

   Beam Therapeutics

   Aug 2025 — Present

   Establish BLA enabling analytical control strategy including defining CQAs, defining a potency assurance strategy, and setting commercial specifications- Develop robust commercial ready release and in-process assays to enable commercialization- Author analytical sections in regulatory documents including IND, IMPD, Type C and Type B briefing books and BLAs- Author quality documents including method tech transfer and qualification/validation protocols and reports- Act as a SME for analytical methods including potency assays, cell-based assays, flow cytometry, ELISAs, PCR based assays to internal and external teams- Apply USP, ICH, and EP guidelines to ensure compliance of analytical methods including compendial methods with regulatory expectations- Oversee internal and external activities including method development, method transfer, method qualification/validation, non-GMP testing, non-GMP stability, reference standard qualification, and comparability- Establish the strategy and studies for product characterization to enable the Elucidation of Structure and Function

Education

• Indian Institute of Technology, Madras

  Bachelor and Master of Technology (B.Tech.) (M.Tech.), Biotechnology

  2006 — 2011

• Boston University

  Doctor of Philosophy - PhD, Cell/Cellular and Molecular Biology

  2011 — 2018

Skills

• Matlab
• Gel Electrophoresis
• Fish
• Statistics
• Western Blotting
• Team Mentoring
• Mammalian Cell Culture
• Genetics
• Drosophila
• Data Analysis
• Chemistry
• Research
• Life Sciences
• Conflict Resolution
• Project Management
• Uv/Vis
• Scientific Presentation
• Immunostaining
• Molecular Biology
• Fluorescence Microscopy
• Cell Biology
• Scientific Writing
• Pcr
• Cell Culture
• Biotechnology
• Mentoring
• Biochemistry