Michael Shanks U.S. FDA

Michael Shanks

Michael Shanks U.S. FDA Senior Biologist, OPQ, CDER

Michael Shanks is a Senior Biologist in the Center for Drug Evaluation and Research at the Food and Drug Administration, where he conducts primary and secondary assessments of drug substance and drug product Quality Modules of Biologics License Applications and supplemental submissions, from a Microbiology and Facility Perspective. He also is lead for establishment inspections of drug substance and drug product manufacturing facilities. Mike has been performing reviews and leading inspections at the Agency for over 10 years. Prior to this, he was in biopharma process and assay development, and technology transfer for 15 years, and conducted cell biology research at Johns Hopkins University for 13 years.