Dr. Mark J. Karbarz is the Executive Director of Biologics Development, Head of CMC. He has over 16 years of industry experience, with an extensive breadth of early and late-stage process development, scale-up and technology transfer, and CMC product development. Most recently, he served as the Director of Process Development at Alexion Pharmaceuticals, a co-Site Lead for Alexion-South San Francisco and a member of the Diversity, Inclusion and Belonging Advisory Board. Prior to Alexion, Mark was at Portola Pharmaceuticals and the CMC strategy lead for Andexanet Alfa. While at Portola, he developed and advanced the commercial Andexxa/Ondexxya manufacturing process from pre-IND through three global regulatory approvals. Prior to Portola, he held positions with increasing responsibilities in the Pain and Related Disorders group at Johnson and Johnson, and the Endocrinology and Metabolic Disorders group at Neurocrine Biosciences. Mark received a B.S. from the University of Illinois, Ph.D. in Biochemistry and Biological Chemistry from Duke University and completed his post-doctoral research at the University of California, San Diego.