Julia O’Neill leads CMC Modeling and Statistics for Moderna as a member of the Technical Development Leadership Team. She is a Fellow of the American Society for Quality and has consulted supporting approval of multiple accelerated products including gene therapy, microbiome, and regenerative medicine. O’Neill worked at Merck (MSD) as Senior Scientific Fellow – Statistics in Regulatory & Analytical Sciences; and Director in Global Technical Operations, with a primary focus on vaccines and biologics. She has over 30 years of experience bridging statistics and chemical engineering, with an MS in Statistics from the University of Wisconsin, and a BS in Chemical Engineering from the University of Maine.