Mike Brewer profile page

Michael Brewer is director and global principal consultant, regulatory for the BioProduction Group at Thermo Fisher Scientific, where he provides global regulatory support and expertise to bioproduction customers. Previously, he led the pharma analytics business, overseeing the development and commercialization of integrated testing applications for microbiology, analytical sciences, and quality control. The products are fully integrated solutions for bacterial and fungal identification, mycoplasma and viral detection, and host cell DNA and protein quantitation. Michael has over 30 years of experience in the biopharma industry, including roles at Scios, Synergen, and Amgen spanning discovery research, analytical sciences, and quality control. Before joining Thermo Fisher Scientific, he led a group at Amgen that developed qualified, validated, and implemented molecular methods for host cell DNA quantitation, contaminant detection, contaminant identification, strain typing, and genotypic verification of production cell lines. His team also supported regulatory submissions, inspections, investigations, remediation activities, and regulatory strategies for new method implementation.