Michelle Frazier-Jessen

Company: Amgen, USA

Dr. Frazier-Jessen has over 12 years of experience in the biotechnology regulatory affairs field and is currently employed at Amgen as a Director, CMC Regulatory Affairs. Prior to this, she was employed at Micromet, Inc. as Senior Director, Regulatory Affairs, at Macrogenics, Inc. and MedImmune, where she held positions with increasing levels of responsibility. Prior to her employment in the biopharmaceutical industry, Dr. Frazier-Jessen was a Review Biologist and Acting Team Leader in the Division of Monoclonal Antibodies, Office of Biotechnology Products at CDER, FDA. Her responsibilities at FDA included research into the role of cytokine signaling in monocytes and macrophages as well as review of Chemistry, Manufacturing and Controls sections of investigation New Drug (IND) applications, biologics license applications (BLAs) and supplements. Dr. Frazier-Jessen also participated in Pre-Approval Inspections (PAIs) and Biennial inspections as a Product Specialist. She is active in numerous professional societies and is an Associate Director for CASSS (California Separation Science Society). Dr. Frazier-Jessen earned her bachelor’s degree in Microbiology from Washington State University and her Ph.D. in Cell Biology, Neurobiology & Anatomy from Loyola University Chicago. She has over six years of post-doctoral research training experience in cell biology/immunology/inflammation.