Dr. Shilpa Gadgil serves as the head of process, analytical and CDMO development - leading on all project initiatives at Enzene Biosciences. Prior to Enzene, Shilpa was the Head of QC at Intas pharmaceuticals, and has lead the organization in several GMP audits from regulatory authorities such as EMA, USFDA, ANVISA, WHO, MOH, Health Canada, etc. Shilpa holds a PhD in Biochemistry from University of Tennessee, Memphis. She has vast experience in the field of diabetes and autoimmune diseases from Universities such as UMass, UCLA etc. with over 30 publications in peer reviewed journals. In here role, she leads end to end development from clone to drug product. She is also the lead for multiple biosimilar products being developed for the EU and US markets.