Brandye Michaels Pfizer
Brandye Michaels Pfizer Senior Director, Microbiology Strategy and Testing
Dr. Michaels, a Senior Director in Analytical R&D at Pfizer, leads the global Microbiology Strategy and Testing team for the Biotherapeutics Pharmaceutical Sciences organization. She is accountable for overseeing operations, compliance, strategic regulatory decisions, and technical advancements for all aspects of microbiology in support of manufacturing cGMP clinical trial supplies. Her team is responsible for ensuring the highest standard of microbial contamination control, from cell banking facilities to the manufacture of final drug product, with a diverse and ever-changing range of biotherapeutic modalities. Dr. Michaels actively engages with external industry forums to influence best practices and new strategies in pharmaceutical microbiology, most recently joining the United States Pharmacopeia (USP) Microbiology Expert Committee. She has a strong passion for exploring innovative technologies and approaches that will enable agile biomanufacturing. Her team’s current projects include pursuing implementation of the recombinant Factor C method for endotoxin testing and Next Generation Sequencing (NGS) for adventitious virus testing. Dr. Michaels has been at the forefront of pharmaceutical microbiology for over 20 years, at Lonza Biologics, Wyeth Pharmaceuticals, and Pfizer. She holds a Ph.D. in microbiology from the University of New Hampshire and a B.S in biology from Georgia Southern University.