Rashmi Kshirsagar has relevant industrial experience in pharmaceutical Chemistry, Manufacturing and Controls (CMC) development based on more than 20 years of CMC development responsibilities in biologics, focused on proteins and cell therapy. Rashmi Kshirsagar joined Be Biopharma as Senior Vice President and will be part of the Operations Leadership Team. Rashmi will be responsible for leading and managing our technical teams. The focus areas for the teams are process, product and analytical development and innovation to advance the B Cell Platform as well as enabling Chemistry, Manufacturing and Controls (CMC) development for our portfolio candidates as they transition from Discovery and move through various phases of clinical development, preclinical to commercialization.
Previously, Rashmi was the VP for Technical Development and CMC Strategy at Rubius Therapeutics, where her responsibilities included leading teams within Rubius that focused on process, product and analytical development and innovation to advance the RED PLATFORM® as well as overseeing CMC strategy and project management for Rubius’ Red Cell Therapeutic™ product candidates that transition from the discovery phase through clinical development. Before that, she was Senior Director for Protein Development in Pharmaceutical Operations & Technology at Biogen. Her group was responsible for developing and supporting manufacturing processes to produce protein drug substance for internal and partnered early and late stage (preclinical to post BLA) biopharmaceutical programs in a compliant manner using industry leading technologies.
She joined Biogen with a PhD in Chemical Engineering from University of Minnesota where she worked with Professor Wei-Shou Hu and prior experience in Technical Development at Millennium Pharmaceuticals. Her graduate work involved application of genomic and proteomic approaches to mammalian process development.
Rashmi has been active for more than 25 years in the scientific community by presenting at conferences, publishing scientific papers and book chapters, planning conferences, conference sessions and workshops and participating in industrial forums and consortia. She has gone through various internal and external leadership development programs and is passionate about people development, organizational effectiveness and diversity and inclusion programs.