Michelle Batz

Michelle Batz is an Associate Director in the Global Development Quality department of Merck Research Laboratories, located in West Point, PA. Over the last 5 years Michelle has had responsibility for redesigning the Quality Management System (QMS) requirements, global procedures and supporting documents that define the Laboratory Controls for Clinical Supply activities as part of the Clinical Supply QMS Redesign Team. This position has afforded her the opportunity to manage cross-functional teams comprised of small molecule, large molecule, drug substance and drug product modalities. Prior to this role Michelle held various roles with the Analytical Sciences department, also within MRL supporting product development, clinical release and stability analysis, project management and GxP Compliance. In her last role in that department she held responsibility for a team of 11 individuals that executed clinical release testing, IND stability testing, drug comparator release and stability testing, excipient/raw material release, compendial testing of packaging components and management of all cleaning validation/verification to support the oral solid dosage pilot plant, sterile dosage pilot plant and the packaging areas for Global Clinical Supplies operations.
Michelle has been a member of ISPE since 2013. She launched the Delaware Valley Chapter of ISPE Women in Pharma committee in 2020 and served as the Vice President of that committee until 2022. She currently is serving as a Director on the DVC Board of Directors and remains a member of the Women in Pharma committee. She holds a B.S. in Chemisty from Arcadia University and M.S. in Organic Polymer Chemistry from Lehigh University.