Dr. Jain co-founded and joined RegenMedTX in 2015 as Chief Operating Officer and has over 33 years of experience in biotechnology, tissue engineering, cell therapy and regenerative medicine bioprocess research & development and GMP manufacturing. Before joining RegenMedTX, Dr. Jain was Senior Vice President of Bioprocess R&D and Technical Operations at Tengion responsible for bioprocess research, process development and clinical manufacturing of advanced regenerative medicine and cell therapy products including urinary bladder replacement and kidney regeneration. Prior to Tengion, Dr. Jain was the Executive Director of Process Development and Manufacturing Technical Support at Advanced Tissue Sciences responsible for development of human-based tissue engineered products for therapeutic applications in the skin, cartilage and cardiovascular areas. Dr. Jain has held several positions of increasing technical and management responsibility at Merck and Johnson & Johnson, leading the development of biotechnology products with a focus on recombinant proteins. Dr. Jain was instrumental in the development and manufacturing support of J&J’s multi-billion dollar product for the treatment of anemia. More recently, Dr. Jain was as a full-time consultant for Baxter Corporation responsible for establishing a commercial manufacturing facility overseas for a marketed recombinant protein.
Dr. Jain is accomplished at directing product development from research to the clinic, process scale-up, technology transfers, GMP facility design, process validation and manufacturing of biotechnology-derived recombinant proteins and tissue engineered cell therapy and regenerative medicine products. He is highly experienced in regulatory CMC submissions for biologics, devices and combination products. Dr. Jain serves as the Chairman of Cell Therapy Ad hoc Advisory Panel for United States Pharmacopoeia and served as a member of USP’s Biologics & Biotechnology Expert Committee. Dr. Jain has also served as Chairman of the American Society for Testing and Materials Task Group on Preservation of Cells and Tissue Engineered Medical Product’s with Cells.
Dr. Jain has over 70 publications, presentations and abstracts, two book chapters and many patents in the field biologics, tissue engineering, cell therapy and regenerative medicine. Dr. Jain received a PhD from the Indian Institute of Technology, Delhi in Biochemical Engineering.