Julia O'Neill

Since 2005, Julia O’Neill has supported approval of multiple accelerated products including vaccine, gene therapy, microbiome, and regenerative medicines. From 2020 to 2023 she was a member of the Moderna Technical Development Leadership Team, where she built and led a new department, CMC Modeling and Statistics, while a member of the Spikevax vaccine technical development team. She was named a Fellow of the American Society for Quality in 2020 in recognition of her passion for connecting people and data across disciplines to accelerate delivery of life-changing medicines to patients at commercial quality scale. She is the 2023 recipient of the ASA Gerald J. Hahn Quality & Productivity Achievement Award, and an Associate Director of CASSS.

From 2005 to 2015 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. Her experience includes development of specifications; stability analysis; development, qualification and validation of analytical methods; process development and qualification; control strategy authoring; comparability assessment; design and implementation of Continued Process Verification programs; and expert Design of Experiments support for a wide range of development programs in vaccines, biologics, gene therapies, small molecules, and other products derived from biological materials. She is a Six Sigma Master Black Belt who built and directed multiple teams which successfully resolved complex investigations, drove sustained improvements, and represented solutions to regulators. Her mentoring has provided encouragement for five colleagues to complete graduate degrees in statistics.

She has over 30 years of experience bridging statistics and chemical engineering in the pharmaceutical and chemical industries. Her education synthesizes statistics and engineering, with an MS in Statistics from the University of Wisconsin, and a BS in Chemical Engineering from the University of Maine.