Mamta Gautam Basak, PhD
About Mamta Gautam Basak, PhD
Mamta Gautam Basak, PhD, is a Senior Director of Regulatory Affairs CMC at BridgeBio, where she supports the development of treatments for rare diseases. With extensive experience in regulatory affairs, she has held significant roles at the FDA, US Pharmacopeia, and Celldex Therapeutics, and is actively involved in mentoring early-stage biotech founders.
Current Role at BridgeBio
Mamta Gautam Basak serves as the Senior Director of Regulatory Affairs CMC at BridgeBio since 2023. In this role, she focuses on regulatory strategies and compliance related to the chemistry, manufacturing, and controls (CMC) aspects of drug development. Her work supports ML Bio Solutions and CoA Therapeutics in their efforts to discover treatments for rare diseases.
Previous Experience at FDA
Mamta Gautam Basak has extensive experience at the FDA, where she worked for 12 years from 2007 to 2019. During her tenure, she held multiple positions, including Senior CMC Policy Advisor, CMC Lead Chemist, and Team Leader. She also served as a CMC Team Lead and Review Chemist from 1993 to 2005, and participated in a NIH Secondment from 2005 to 2007, contributing to her deep understanding of regulatory frameworks.
Educational Background
Mamta Gautam Basak holds a Ph.D. in Analytical Chemistry from the Indian Institute of Technology, Delhi. She also earned an M.Sc. in Chemistry from Delhi University, where she studied Chemistry with minors in Physics and Mathematics. Additionally, she obtained a Postgraduate Diploma in Chemical Engineering from the Tokyo Institute of Technology.
Mentorship and Advisory Roles
In addition to her regulatory work, Mamta Gautam Basak actively mentors early-stage biotech founders, emphasizing support for female entrepreneurs and scientists. She has served as an angel investor and regulatory advisor at prominent institutions, including Harvard, UC Berkeley, and Carnegie Mellon, sharing her expertise to foster innovation in the biotech sector.
Language Proficiency
Mamta Gautam Basak is fluent in three languages: English, Hindi, and Bengali. This linguistic proficiency enhances her ability to communicate effectively in diverse professional environments and contributes to her role in international collaborations.