Aishwarya Sathyanarayan

About Aishwarya Sathyanarayan

As a Senior Principal Scientist in Technical Operations at Genentech, a clinical-stage biotechnology company, I lead CMC (Chemistry, Manufacturing, and Controls) activities for novel cell and gene therapies (C>) targeting cancer and genetic diseases. With over seven years of industry experience in the biotechnology and pharmaceutical sectors and a Ph.D. in Nutrition Sciences with a focus on Biochemistry, I bring both scientific depth and strategic leadership to advancing innovative therapies.My core strengths include:1. Development and optimization of phase-appropriate assays and clinical lot release testing for CAR-T platforms2. Defining and evaluating Critical Quality Attributes (CQAs) and conducting comprehensive risk assessments for final drug products3. Cross-functional collaboration with regulatory and quality organizations to ensure compliance with FDA and global regulatory standards4. Specialized expertise in metabolic diseases and viral vector platforms, particularly in the context of C> applicationsI am deeply committed to driving innovation in cell and gene therapies and delivering impactful solutions to patients with unmet medical needs.

Experience

1. Technical Development Senior Principal Scientist

   Genentech

   Jun 2025 — Present · San Diego, CA, US

   Lead a team of analytical scientists in the development of the strategy and methods required for characterization of Cell Therapeutics- Strive for molecule CQA understanding through analytical characterization and collaborations with research, non-clinical and clinical organization personnel- Author and review technical development documents and relevant sections of CMC filings- Serve as a team representative and provide analytical knowledge and expertise to cross-functional teams

Education

• Keck Graduate Institute

  Managing Science in the Biotech Industry: An Intensive Course for PhD Students and Postdocs

  2016 — 2016

• University of Minnesota

  Doctor of Philosophy - PhD, Biochemistry and Molecular Biology

• Mount Carmel College, India

  Bachelors, Microbiology, Chemistry, Zoology

• Bangalore University

  Masters, Microbiology

• University of Minnesota

  Doctor of Philosophy (Ph.D.), Nutrition Sciences (Biochemistry)