)

Jesse Milling
Owner,
Process By Design CMC Consulting
Jesse Milling brings nearly two decades of experience in biologics and cell and gene therapy, with a career spanning Fc fusion proteins, viral vectors, and iPSC-derived therapeutics. He has led comprehensive Chemistry, Manufacturing, and Controls (CMC) strategies across the full development lifecycle-from early product concepts to successful commercial approvals. Jesse’s expertise includes process development, GMP manufacturing, and cross-functional program leadership. His work has been instrumental in advancing innovative therapies from bench to bedside, with a strong focus on scalable, regulatory-compliant manufacturing solutions.
Sessions