Saurabh Sharma
Head of CMC

Saurabh Sharma is an experienced professional with over eight years in gene therapy process development and manufacturing for rare diseases. His skill set includes designing and executing scalable processes for both drug substance and drug product using various bioreactor and flatware technologies. He also specializes in developing analytical methods for characterizing processes and products and collaborates with contract development and manufacturing organizations (CDMOs) for GMP manufacturing. While at Janssen Biotech, Saurabh was a Senior Scientist, where he spearheaded the drug product development process, focusing on formulation screening and development for adeno-associated virus (AAV) gene delivery products. His leadership was crucial in advancing late-phase drug substance process development. Additionally, at Krystal Biotech, he showcased his leadership as a Senior Engineer, managing development activities for viral vector production platforms and downstream processes for HSV. Academically, Saurabh holds a Master's degree in Chemical Engineering from the University of Florida and a Bachelor's degree from Manipal University in India. His comprehensive skill set encompasses various aspects of gene therapy process development, including upstream and downstream processes for AAV and HSV, both suspension and adherent cell culture techniques, purification methods such as filtration, TFF, and chromatography, as well as design of experiments (DOE), quality by design (QbD), process characterization, analytical development, GMP processes, formulation development, and drug development strategy.