Distinguished Fellow, CMC Modeling and Statistics Lead @ (September 2020 - Present)
Principal @ (April 2015 - December 2018)
Founder and Principal Consultant @ Direxa Consulting (October 2018 - Present)
Director - Engineering @ (October 2011 - April 2015)
Principal Engineer @ (April 2008 - October 2011)
Senior Scientific Fellow - Regulatory and Analytical Sciences @ (March 2005 - March 2008)
Process Development Leader @ (February 2002 - January 2005)
Senior Statistician @ (August 1995 - January 2002)
Quality Control Laboratory Manager @ (July 1993 - May 1995)
Statistical and Quality Consultant @ (February 1991 - June 1993)
Research Statistician @ (June 1988 - January 1991)
Process and Product Technical Service Engineer @ (June 1981 - July 1984)
Julia O'Neill Education
Portland High School
University of Maine
Bachelor Of Science (Chemical Engineering)
University of Wisconsin - Madison
Master Of Science (Chemical Engineering, Statistics)
Julia O'Neill Skills
Affinity Diagramming
Biotechnology
CAPA
CMC
CPV
Chemical Engineering
Continued Process Verification
Cross-functional Team Leadership
Data Analysis
Data Mining
Design of Experiments
Distillation
FDA
GMP
Good Manufacturing Practice (GMP)
Hoshin
JMP
Manufacturing
Measurement System Analysis
PLS
Pharmaceutical Industry
Process Capability Assessment
Process Optimization
Process Robustness
Project Management
R&D
Research and Development (R&D)
SIPOC
SPC
Six Sigma
Six Thinking Hats
Statistical Engineering
Statistical Process Control
Statistical Process Control (SPC)
Technology Transfer
U.S. Food and Drug Administration (FDA)
Validation
bioassay
interrelationship digraph
process control
random forests
Research and Development R&d
u.s. Food and Drug Administration Fda
Cross Functional Team Leadership
Statistical Process Control Spc
Research and Development
u.s. Food and Drug Administration
Julia O'Neill Summary
Julia O'Neill, based in Glenside, PA, US, is currently a Founder & Principal Consultant at Direxa Consulting LLC. Julia O'Neill brings experience from previous roles at Sas, Moderna Therapeutics, Tunnell Consulting, Inc. and Direxa Consulting. Julia O'Neill holds a Portland High School. With a robust skill set that includes Affinity Diagramming, Biotechnology, CAPA, CMC, CPV and more. Julia O'Neill has 1 emails and 1 mobile phone numbers on RocketReach.
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