Mamta Gautam-Basak

Mamta Gautam-Basak, PhD, is a seasoned professional in regulatory affairs with extensive experience across various roles in the biopharmaceutical industry. Currently serving as Senior Director of Regulatory Affairs CMC at BridgeBio since March 2023, Mamta supports ML Bio Solutions and CoA Therapeutics in developing treatments for rare diseases. Prior positions include Senior Director of Regulatory Affairs CMC at Celldex Therapeutics, where responsibility encompassed CMC regulatory strategies for monoclonal antibodies and immunomodulators. Mamta has also provided strategic oversight as a Senior Technical Advisor for a USAID global program at US Pharmacopeia and served as Executive in Residence at Columbia Technology Ventures. A long tenure at the FDA involved roles such as Senior CMC Policy Advisor and CMC Team Lead, while earlier career stages included positions at the National Institutes of Health and various postdoctoral research roles. Educational credentials include a PhD in Analytical Chemistry from the Indian Institute of Technology, Delhi, and advanced degrees in Chemistry and Chemical Engineering from Delhi University and Tokyo Institute of Technology.