Sourav Kundu, Ph.D.

Dr. Sourav Kundu has 30+ years of process, analytical and drug product development and manufacturing experience for early/late-stage clinical and commercial programs. Prior to joining Pharmefex, Dr. Kundu was the Senior Vice-President at NextCure, a clinical-stage biotech, leading CMC development and clinical manufacturing of novel ADCs, mAbs and fusion proteins. His responsibilities spanned from advancing programs to clinical development, managing supply chain, managing global CDMOs and IND/IMPD filings. He extensively collaborated with multiple ADC development partners globally. 

Dr. Kundu’s tenure at Teva Pharmaceutical spanned 9 years at positions of increasing responsibilities ultimately leading a 160+ global development and manufacturing organization. He was a Director of Process Development, Senior Director of Clinical Manufacturing and Vice-President of Biologics R&D. He led CMC development and commercialization of Ajovy® and Cinqair® and provided hands-on technical oversight to technology transfer to CDMO, scale-up, pivotal manufacturing, PPQ and worldwide regulatory approvals. He was instrumental in advancing Teva’s novel biologics and biosimilars by leading drug substance/product and analytical teams, supporting numerous IND/IMPDs and leading clinical supply manufacturing at a GMP facility that was designed and built under Dr. Kundu’s leadership.

Dr. Kundu worked at Amgen for 8 years and was a Director of Process Development at one of Amgen’s largest commercial manufacturing facilities. He and his team were critical resources for day-to-day technical support to commercial manufacturing of Enbrel® and Vectibix® and ensuring drug substance supply. He led continuous improvement projects for the plant and provided critical technical leadership to cost/yield improvements, optimization of operational practices and implementation of advanced process control technologies. He was instrumental with conversion of the single product facility to a multiproduct facility and securing regulatory approval.

Dr. Kundu held additional positions of increasing responsibilities at CSL and Siemens leading development and technical support teams for various revenue-critical programs. He holds a Ph.D. in Chemical Engineering and an M.B.A.