Kavita Aiyer

Dr. Kavita Aiyer is a global Regulatory Affairs–CMC leader with over 20 years of experience in the healthcare industry, spanning biologics, complex biologics, vaccines, combination products, and novel platforms such as mRNA. Before transitioning to Regulatory Affairs, she led vaccine manufacturing, process development, GMP facility establishment, technology transfer, internship programs, and participated in site audits. A certified Lean Six Sigma Black Belt, Dr. Aiyer has driven operational excellence through Kaizen, Six Sigma, and Lean methodologies. Recognized as an industry expert in Analytical Comparability, she has held progressive leadership roles bringing multiple products to global markets. Dr. Aiyer is an active contributor to global trade associations and consortia, including IFPMA and BioPhorum, where she collaborates on position papers and speaks on emerging regulatory science, innovation, and lifecycle management strategies. She serves as the Associate Director of CASSS, is a member of its Scientific Organizing Committee, and holds leadership roles as a conference forum and session chair. In addition, she serves on the BioProcess International editorial board. She earned her Ph.D. in Biotechnology from Anna University, India, and completed postdoctoral research at the University of Minnesota in antibody engineering and synthetic biology.