As VP of Manufacturing Operations at Just – Evotec Biologics Renae is leading the start-up of our new late-stage clinical and cGMP commercial J.POD® manufacturing facility coming on-line in 2021.
Renae is a Biotechnology Operations leader with over 29 years of end-to-end GMP manufacturing, supply chain, and facilities global management experience that spans plant start-up to clinical and commercial manufacturing of biologics in multi-product/multi-host facilities (mammalian and microbial), pharmaceuticals, and medical devices. Throughout her career, Renae has successfully led several successful New Product Introductions, technology transfers, changeovers, start-ups, turn-arounds, and plant shutdowns/site closures for Amgen, Inc., Protein Design Labs, Smith & Nephew and, most recently, Thermo-Fisher (Patheon). This includes GMP manufacturing of cell banks, API’s, bulk drug substance, and finished drug product.
She maintains a strong focus on operational sustainability/business continuity, high success rates, and operational excellence having experience working on various lean initiatives. In addition, Renae is considered an industry expert on aseptic technique, aseptic processing, contamination control, and GMP compliance having inspection experience with various regulatory agencies – domestic and international.
Renae received her Bachelor of Science degree in Math/Science and Athletic Training from the University of Mary. Renae was an Academic All-American National Scholar Athlete and was inducted into the University of Mary Hall of Fame.