Sharmista Chatterjee is currently the Division Director in Division of Process Assessment II, within FDA’s Office of Process & Facilities (OPF). Sharmista has been with the FDA since 2006. During her tenure, she has been actively involved in new drug’s Quality by Design efforts, FDA-EMA QbD pilot program and Continuous Manufacturing. She served as the CMC Lead for QbD (Quality by Design) in the Office of New Drug Quality Assessment (ONDQA) and as the technical lead for the FDA-EMA QbD pilot. She is an Agency Expert in CMC Modeling and Simulation. In addition to her current responsibilities, she is serving as one of OPF representatives in CDERs Emerging Technology Team. Prior to joining the agency in 2006, she spent around 10 years in industry. Her industry experience was primarily in process development and modeling in diverse areas that ranged from consumer goods to pharmaceuticals with companies such as United Technologies Corporation (UTC), Procter and Gamble (P&G), and Forest Laboratories (now Allergan). She received a bachelor’s degree in Chemical Engineering from Indian Institute of Technology and a PhD in Chemical Engineering with a co-major in Biomedical engineering from Iowa State University.