Venkatesh has 15 plus years of Biopharmaceutical manufacturing and clinical development experience with extensive technical and strategic leadership for end-to-end manufacturing for early phase to commercial-scale manufacturing.
Currently, serving as Director, Manufacturing Science and Technology (MSAT) at CCRM where the primary focus is to oversee and manage CDMO technical operations, including technology transfer, process design and validation, and Scale-up of autologous and allogeneic cell therapy products, including drug substance and drug product. Efficiently managed technical manufacturing operations and Compliance program to improve CDMO capacity, i.e., autologous multi-patient batch production utilizing semi or fully functional closed systems.
Prior to joining CCRM, Venkatesh served as Senior Director of Cell Processing Facility and Clinical development at TotipotentRX-Cesca Therapeutics, where he led and managed processing of hematopoietic stem cell transplant program, haploidentical stem cells, established MCB/WCB, led and managed cord blood processing and banking, served as study director of 7 cell-based therapy Clinical trials including IND/IDE submissions.
Venkatesh has MSc in medical microbiology and holds a PhD in Cancer and Radiation Biology from Manipal University, followed by a post-doctoral fellowship in Gastrointestinal Inflammation at the University of Illinois, Chicago. Venkatesh has co-authored 50 plus publications, several book chapters, and four patents related to stem cells, regenerative medicine, and cancer biology. Venkatesh is actively involved in several professional organizations like FACT, ISCT, and AABB and serves as an editorial member and reviewer on several journals.