Mike Brewer

Experience

1. Director, Global Principal Consultant, Regulatory, Bioproduction

   Thermo Fisher Scientific

   Nov 2018 — Present · Boston, MA, US

   I am currently Director, Global Principal Consultant, Regulatory for the BioProduction Division (BPD) at Thermo Fisher Scientific. In this role, I am responsible for providing global support to BioProduction customers and serving as the regulatory thought leader and expert across all technology areas within BPD. Prior to moving to this role, I led the team responsible for product applications including Microbiology, Analytical Sciences and Quality control. In that role, the team I led grew the business from a single product line to a multi-product portfolio of industry leading solutions for Biopharma quality and safety testing. The products are fully integrated, solutions for N-Glycan profiling, Bacterial and Fungal identification, Mycoplasma and Viral detection and host cell DNA and protein quantitation. I have over 30 years experience in the Biopharma industry, including, Scios, Synergen and Amgen in a variety of roles including Discovery Research, Analytical Sciences and Quality Control. Immediately prior to joining Thermo Fisher Scientific, I led a group at Amgen that developed qualified, validated and implemented molecular methods for host cell DNA quantitation, contaminant (Mycoplasma, Virus and Bacteria) detection, contaminant identification, strain typing and genotypic verification of production cell lines.