Mic McGoldrick Merck Sharp & Dohme Corp. LLC

Mic is currently an Associate Director of CMC Technical Advocacy & Policy at Merck Sharp and Dohme, Corp. His background in the life sciences started with degrees in Microbiology, Chemistry, and Medical Technology and has experience with Vaccine and Biologics in the Pharmaceutical field for the last 30 years. For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, and post approval submissions globally. For a large portion of this time he led the evaluation of worldwide guidances and the expansion of vaccines into the Emerging Markets. For the last seven years Mic has been working on CMC Policy for Vaccines and Biologics, advocating for reliance, harmonization and greater access of vaccines to patients.