Julia O'Neill

Julia O'Neill

Founder & Principal Consultant, Direxa Consulting

Julia O’Neill is Founder and Principal Consultant of Direxa Consulting. She previously led CMC Modeling & Statistics as a Distinguished Fellow at Moderna, where she served as a member of the Technical Development Leadership Team.

Prior to joining Moderna, O’Neill worked at Merck (MSD) as Senior Scientific Fellow of Statistics in Regulatory & Analytical Sciences and Director of 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; 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 have successfully resolved complex investigations, driven sustained improvements, and represented solutions to regulators. Her mentoring has provided encouragement for five colleagues to complete graduate degrees in statistics.

O'Neill is currently a Fellow of the American Society for Quality and recipient of the 2023 Gerald J. Hahn Q&P Achievement Award. Since 2005 she has consulted to support the approval of multiple accelerated products, including gene therapy, microbiome and regenerative medicine. 

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