Dr. Sharmista Chatterjee is the QbD Lead in the Office of New Drug Quality Assessment (ONDQA) at the FDA. She is currently serving as the technical lead for the FDA-EMA QbD pilot and as a co-chair for IFPAC 2014. Her other responsibilities include mentoring and training reviewers in assessment of QbD based applications, providing consults for review of QbD based applications, supporting development of review practices and policies associated with QbD based new drug applications and also supporting QbD related research initiatives within the office. She received a BS in Chemical Engineering from Indian Institute of Technology and a PhD in Chemical Engineering from Iowa State University. 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 industries that included energy, consumer goods, food and pharmaceuticals.