Shashi Sivakumar

Balasubramanian "Shashi" Sivakumar is an Associate Principal Scientist in Biopharmaceutical Development at AstraZeneca. As a CMC expert, he represents AZ in the IQ Consortium’s IPAC Working Group to align industry vial fill practices with FDA expectations. His technical expertise includes Antibody Drug Conjugate formulations, lyophilization cycle design, scale-up and tech-transfer, sterilization, and managing First-To-File (FTF) BLAs. Prior to AstraZeneca, Shashi held senior scientific leadership roles at companies including REGENXBIO, MacroGenics, Allergan, and DSM. He earned his Ph.D. in Pharmaceutical Sciences from Long Island University and has a successful track record of transitioning products from early-stage formulation through clinical manufacturing to regulatory approval.