Julia O’Neill

Background

Statistician in development and Chemistry, Manufacturing & Controls (CMC) for biopharmaceuticals. Designed and taught a full-day course on CMC Statistics by invitation from the FDA Staff College. Ongoing support for accelerated programs including breakthrough designation and orphan drug products. ASQ Fellow.

MS University of Wisconsin-Madison, Statistics December 1987
Studied with W. G. Hunter. G. E. P. Box, N. Draper, D. Bates

BS University of Maine, Chemical Engineering May 1981
With Highest Distinction and Honors

Moderna Therapeutics, Cambridge, MA, 2020 to current
Distinguished Fellow, CMC Statistics Lead

• Lead the integration of CMC statistical strategy throughout Technical Development. Reporting to the Senior Vice President of Technical Development, member of the Technical Development Leadership and Management Team (TDLMT). Provide scientific mentorship to scientists and engineers for the application of quantitative methods in support of Quality by Design for product development and manufacturing, including experimental design, statistical modeling and data-based decision making. Partner with statisticians and data scientists in related functions.  
• Lead statistical components of regulatory content for submissions such as IND and BLA. Represent Moderna in meetings with regulatory agencies. Construct a compelling narrative based on data and evidence. Contribute to successful commercial Pre-Approval Inspections, regular Audits and any other interactions with regulatory agencies as required.

Direxa Consulting, Glenside, PA 2018 to current
Founder & Principal Consultant

• • Statistical resource to leading clinical-stage biotechnology and pharmaceutical companies and contract development and manufacturing organizations. Products supported include vaccines, gene therapies, oncolytic viruses, microbiome products, and others derived from biological starting materials.
  • Quality by Design (QbD), statistical design and analysis of experiments (DoE) with special expertise in robust process design and formulation (mixture) experiments, control strategy development, justification of specifications, multivariate modeling of starting material properties and process history, stability study design and modeling, estimation of shelf life and internal release limit, propagation-of-error simulation, biological assay design including cell-based potency assays, reference standard qualification and bridging, analytical method qualification and validation, nonlinear (4PL) curve fitting and relative potency, variance assessment and replication strategy, animal studies, process characterization, validation and comparability, deviation investigation and resolution, ongoing process monitoring including Continued Process Verification (CPV).

Tunnell Consulting, King of Prussia, PA 2015 to 2018
Principal

• • Consultant to a wide range of pharmaceutical and biotechnology clients, overseeing complex statistical projects and coordinating expert teams.
  • Developed and led Tunnell solution for Continued Process Verification.

Merck, West Point, PA 2005 to 2015
Director, Global Technical Operations

• Lead the development of strategy and executed installation for Continued Process Verification at all Merck vaccine and biologics manufacturing sites.
• Built a SWAT team of engineers employing Six Sigma methodology to identify root cause and corrective actions for some of the most challenging issues in viral vaccine manufacturing.
• Directed the annual performance assessment of all Critical Quality Attributes and Continued Process Verification for all Merck products globally.
• Vaccine Specification Committee, with responsibility for specifications at all phases of the product life cycle, from safety assessment to licensed product.

Senior Scientific Fellow – Statistics, Regulatory & Analytical Sciences

• Statistics support for a high volume of projects in Merck vaccines and pharmaceuticals.
• Led a team of statisticians and engineers to author a Merck Manufacturing Division-wide Quality Guidance for Application of Statistical Process Control for Process Monitoring and Data Analysis, followed by all Merck manufacturing sites globally.

Rohm and Haas Co., Spring House, PA 1988 to 2005
Powder Coatings Process Development Leader
Senior Research Statistician
Quality Control Laboratory Manager
Statistical and Quality Consultant

• Scientific and managerial positions with increasing responsibility and scope, spanning roles from research and development to corporate training and development.

FDA Staff College, Silver Spring, MD 2016

• Developed and taught full-day course on CMC Statistics by invitation from CBER vaccine biostatisticians.

Drexel University, Philadelphia, PA January 2008 to June 2008
Adjunct Professor, Department of Decision Sciences

• Developed and taught Six Sigma Quality Implementation, a four-credit undergraduate course with 15 students, preparing them for certification.
• Wrote and graded all lessons, quizzes, exams, and homework

Book Chapters

Gampfer, J. and O’Neill, J., Applications of MVA for Product Quality Management: Continued Process Verification and Continuous Improvement In: Ferreira AP, Menezes JC, Tobyn M, eds. Multivariate Analysis in the Pharmaceutical Industry. San Diego: Academic Press, 2018: 347-406.

Journal Publications

Overcoming the Challenges of Patient Centric Specification Setting, Richard K Burdick and Julia C O’Neill, Life Science Leader Special Issue: CMO Leadership Awards, April 2020.

The Goldilocks Challenge-Balancing Risk When Setting Product Specifications, Richard K Burdick and Julia C O’Neill, PDA Journal of Pharmaceutical Science and Technology January/February 2020, pdajpst.2019.010850; DOI: https://doi.org/10.5731/pdajpst.2019.010850.

How to get JMP to make you look like a magician, Julia O’Neill, JMP Foreword, 2019.

Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities, Journal of Pharmaceutical Innovation, published online 14 December 2018, J. Bercu et al.

Developing Control Strategies For Gene Therapy Products — What Role Should CMOs Play?, Outsourced Pharma guest column, October 19, 2018.

Losing Sight of the Intended Purpose of Specifications Has Consequences For The CMO-Sponsor Relationship, Life Science Leader, March 7, 2018, Julia O’Neill.

ISPE Process Capability Maturity Model: How Robust Is Your Process Capability Program?, Pharmaceutical Engineering, 38(1), January-February 2018, Philippe Cini, Gretchen Allison, Gerald Leister, Eda Ross Montgomery, Julia O’Neill, Paul Stojanovski, Michael Thomas, and Arne Zilian.

BPOG, 2017, Continued Process Verification of Legacy Products in the Biopharmaceutical Industry, © 2017, BPOG – Biophorum Operations Group (one of Main Authors).

Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification, BioProcess International, 15(1), January 2017, JR Dobbins, Stefanie Pluschkell, Timothy Schofield, Philip Krause, Julia O’Neill, Patrick Swann, and Joel Welch.

BPOG, 2014, Continued Process Verification: An Industry Position Paper with Example Plan, © 2014, BPOG – Biophorum Operations Group (Lead Contributor).

Statistical Engineering to Stabilize Vaccine Supply, Quality Engineering, 24, 2012, Julia O’Neill et al., p. 227-240.

Statistics to Facilitate Innovation: A Panel Discussion, ASQ Statistics Division Special Publication, 2011.

Building Process Understanding for Vaccine Manufacturing using Data Mining, Quality Engineering, 22:3, 2010, Matthew C. Wiener, Louis Obando, Julia O’Neill, p. 157-168.

Materials of Construction Based on Recovery Data for Cleaning Validation, Pharmaceutical Technology, October 2007, Richard J. Forsyth, Julia C. O’Neill, and Jeffrey L. Hartman, p. 102-116.

Power-controlled bonding of resin or (co)polymer powder and flake materials, European Patent Application Publication 05255429.2, O’Neill, Sarafinas and Snyder, 2005.

Raw mix powder compositions and methods of making the same, European Patent Application Publication 05252552.4, Correll, Horinka, O’Neill and Zimmerman, 2005.

DOE Software Paints Picture of Powder Coating Defects, Powder Coating, Vol. 14, April 2003, Tryg Helseth and Julia O’Neill, p. 12-15.

Coating MDF the Right Way, Paint & Coatings Industry, February 2003, Gordon Tullos, Paul Horinka, and Julia O’Neill, p. 36-41.

Color Matching and Simulation of Multicolor Surfaces, United States Patent Application Publication 2003/0208345 A1, O’Neill et al., 2002.

Optimal Assignment of Samples to Treatments for Robust Design, Quality and Reliability Engineering International, Vol. 16, September-October 2000, Julia O’Neill, Connie Borror, Peter Eastman, Debra Fradkin, Michael James, Allen Marks, and Douglas Montgomery, p. 417-421.

Control Strategy Grounded in Process Modeling, PDA/FDA Joint Regulatory Conference, 2020.

Accelerating Commercialization of Therapies for Unmet Medical Needs, Wiley CHEManager webinar, 2020.

Building a Culture of Analytics, JMP Statistically Speaking, 2020.

Specification Setting and Comparability, FDA Office of Tissues and Advanced Therapies seminar, 2019.

Quality by Design as a Framework for Modeling, JMP Explorer Series, 2019.

Bridging Statistics and Chemical Engineering for Biotech and Pharma, JMP Analytically Speaking, 2018.

Control Strategy for Cell & Gene Therapy Products, Process Validation Summit, 2018.

The Goldilocks Principle: Setting Limits That Are Just Right, Annual Microbial Contamination and Control Symposium, 2018.

Developing Control Strategy for Gene and Cell Therapies – Journey of Unique Challenges, PDA Cell & Gene Therapy Conference, 2017.

Defining Limits to Represent Patient Needs and Process Capabilities, ISPE Annual Meeting, 2017.

Saving Lives with Statistics: A Framework for Statistical Applications in Pharmaceutical Manufacturing & Development, Fall Technical Conference of the ASA & ASQ, 2017.

The Key Role of Specifications in Process Validation, Process Validation Summit, 2017.

Process Capability, DMPQ seminar, 2015.

Process Analytics to Enable Reliable Supply, Big Data & Analytics for Pharma Summit, 2014.

Process Validation for Biologic Drug Products, AAPS National Biotechnology Conference short course, 2014.

Statistical Issues in Continued Process Verification, PDA Annual Meeting, 2013.

Data Mining Builds Process Understanding for Vaccine Manufacturing, Well Characterized BioPharmaceuticals (WCBP), 2009.

Master Black Belt
Merck Sigma, 2009
Game-changer project returned a vaccine with $100 million annual sales to the market by resolving a challenging manufacturing issue. Novel analytics applied to process data set a new standard for complex investigations across entire Merck Manufacturing Division.

Black Belt
Merck Sigma, 2007
Project eliminated low-potency lot failures for VARIVAX® filled containers, valued at $713,600 discards prevented.

Fellow, ASQ 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.”

Merck Chairman’s Award 2014
Keytruda (Pembrolizumab) launch

Merck Manufacturing Division President’s Cup Award 2013
Vaccines Technical Operations Playbook

Merck Manufacturing Division Award 2013
CBER Approval of Varicella Potency Staining & Counting Machine

Merck Award for Excellence 2012
Process Approval from FDA CBER for Varicella HVF Concentration Process

Shewell Award 2009, 2006, 2003
Best presentation at the Fall Technical Conference (ASA & ASQ)

Merck Manufacturing Division Lean Six Sigma Award Finalist 2009
VAQTA® Bulk Antigen Content Investigation

Merck Manufacturing Division Lean Six Sigma Best Methodology 2009
Varicella Bulk Manufacturing Control Cell Investigation

Merck Research Laboratories Award 2008
Best Speaker at the Insight from Data Analysis and Exploration Day

Merck Special Achievement Award 2006
Outstanding leadership of the Statistical Process Control Guidance Team

Irwin S. Hoffer Award, Philadelphia ASQ 2004
Leadership in Statistical Thinking

ISPE (International Society for Pharmaceutical Engineering), 2017 – current.
Clinically Relevant Specifications Working Group

CASSS – An International Separation Science Society, 2016 – current.
Associate Director, WCBP Scientific Organizing Committee

Quality Engineering, 2006 – current.
Editorial Board Member, reviewer.

PDA Journal reviewer, 2019 – current.

Outsourced Pharma Editorial Board Member, 2017-2020

American Society for Quality (ASQ), 2002 – current.
Fellow, elected 2020.

American Statistical Association (ASA) member.

BioPhorum Operations Group (BPOG), 2012-2015.
Represented Merck in external collaboration on Continued Process Verification.

Brumbaugh Award Committee Chair, 2009 – 2016.
Lead committee to select the paper that has made the largest single contribution to the development of industrial application of quality control in the previous year.

Nelson Award Committee 2005, 2006, 2007 and 2008.
Select the paper appearing in the Journal of Quality Technology during the previous year with the greatest immediate impact for practitioners.

ASQ, Chair – Chemical and Process Industries Division (CPID), 2005-2006.

Maine Cancer Foundation
Raised over $2,000 per event and competed in Tri for a Cure sprint triathlons, Portland, ME, 2012 and 2015

Komen 3-Day Breast Cancer Walk
Raised over $2,000 each year and walked 60 miles, Philadelphia, PA, 2005, 2006, 2007, and 2008

English: Native Language
French: Intermediate

Expert JMP user. Most modeling performed in JMP to make it easy for clients to learn, update and run themselves.

Develop high-performing teams and people by connecting, coaching, and serving as a role model for aspiring data scientists and women in STEM careers. Five scientists earned graduate degrees in quantitative fields motivated by my example.