Dr. Gehrke has over 25 years of experience in CMC, regulatory affairs, analytical development, bioanalysis, and quality systems across biotechnology, pharmaceutical, and contract research organizations. His experience spans small molecule, peptide, biologic, and combination product programs from discovery through commercialization. Dr. Gehrke’s CMC responsibilities have included regulatory strategy development, analytical and manufacturing oversight, stability programs, quality systems, and the preparation of global regulatory submissions, including INDs, NDAs, BLAs, IMPDs, and 510(k)s.
Dr. Gehrke’s previous industry positions include Principal Regulatory Affairs CMC Specialist at Upsher-Smith Laboratories, LLC and Senior Director of CMC and Bioanalysis for Proximagen, LLC. He currently serves as Team Lead CMC and Senior Consultant at Dunn Regulatory Associates, where he leads CMC regulatory strategy and supports development and commercialization programs for small molecules, peptides, biologics, and combination products.
He received a Ph.D. in Analytical Chemistry from Missouri University of Science and Technology.