Rubi Burlage, Ph.D. is Associate Vice President, Sterile Product and Device Development at Merck & Co., Inc. In this role, Rubi is responsible for leadership of Merck’s sterile small molecule, biologics, and vaccine drug product design and development. In previous roles, Rubi has served as Executive Director, Sterile Drug Product Commercialization within Merck’s manufacturing division leading commercialization of Merck’s sterile therapeutic and vaccines drug products. Previously, Rubi has also led innovation in sterile and specialty products including development of oral solid dosage forms and associated lifecycle management strategies advancing products from first-in-human to commercialization, in roles of increasing responsibility. Rubi’s interests include understanding biopharmaceutical and mechanistic principles influencing dosage form design, studying factors germane to successful product and process scale up, and developing risk-weighted strategies for drug product commercialization. She is a co-author on several publications and co-inventor on 3 patents. Rubi earned a B.S. from India and Ph.D. from The University of Iowa. Dr. Burlage is a member of the American Association of Pharmaceutical Scientists (AAPS) and member of the Drug Product Leadership Group for the International Consortium for Innovation & Quality in Pharmaceutical Development (IQ).