Rebecca Gentile is an Associate Director in Merck’s Quality Division of Vaccine and Biological Stability. She leads a team which provides global oversight of stability programs for biologics programs from Phase 3 development through the commercial life cycle.
Ms. Gentile holds a B.S. degree in Chemistry from The College of New Jersey (TCNJ) and an M.S. in Quality Assurance and Regulatory Affairs from Temple University. She began her career with Merck in 1996. She started in the Merck Research Labs, developing analytical assays which were used to monitor the stability of pharmaceutical products. She then held positions of increasing responsibility in pharmaceutical, vaccine, and biologics stability groups, including support of drug substance, drug product and medical device combination products. She has designed stability strategies and authored regulatory filings in support of development and commercial products. She has spent the past 15 years defining Merck's distribution strategy for commercial products from a stability perspective.