
Sesha Srinivasachari
Principal Consultant
Sesha Srinivasachari is a seasoned biopharmaceutical professional with 27+ years of
experience in all phases of clinical development through roles in Manufacturing, Supply
Chain, Quality, Program Leadership and Project Management. Sesha has a strong cGMP
manufacturing background in biologics, cell therapies, combination products & peptides in
both drug substance and drug product unit operations. Most recently, he was a Vice President
at Kyverna Therapeutics, where he was the Program Lead for their autologous CD-19 CAR-T
program. Prior to that, he was the Head of Manufacturing and Supply chain at Kyverna. Prior
to Kyverna, he served in various capacities within technical operations in companies such as
Genentech, Intarcia and Dermira. Sesha is experienced in managing CMOs / CDMOs, leading
internal clinical and commercial manufacturing teams, leading capital projects, technology
transfers, late-stage development, process validation and process optimization / operational
excellence (LEAN, Six Sigma, Value Stream mapping). Sesha is well versed with CMC
strategies and regulatory filings (IND, BLA, CTA, NDA) for multiple modalities. Sesha has
experience in interactions with regulatory agencies and leading regulatory inspections. Sesha
has an MBA from Haas School of Business (UC Berkeley) and holds a Bachelor of
Engineering degree from Madurai Kamaraj University, India.