Jaime Marach is currently leading CMC Quality at IGM Biosciences and serves on the United States Pharmacopeia volunteer panel that wrote and published USP chapter <1220>, Analytical Procedure Lifecycle. Jaime is passionate about strategic and lean product development in CMC, encompassing development of phase appropriate analytical methods and validations, quality oversight and regulatory compliance. Jaime has developed > 100 small and large molecule products, led laboratories through transformations to increase compliance, quality, throughput and on time delivery. Jaime obtained her PhD in Biomedical Sciences from the University of California, San Diego, expressing and characterizing protein variants, and studying cell signaling.