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Meet the Speaker: John O'Neill

With our international installment Stability Testing taking place this year in Dublin, we asked one of our highly-regarded speakers, John O'Neill, Associate Director of QC Stability of Regeneron, if we could learn more about him. Read on to hear about his industry, career highlights, and even how he likes his pizza. 

To meet John O'Neill in person and to hear him speak on stability programs, join our domestic Stability Testing event taking place this December in Philadelphia.

How did you end up in the life sciences industry?

Coming from a family of Pharmacists created an interest in advancing the cause of human health and well-being.  By happenstance, my original plan to become a hospital pharmacist took a twist into the world of pharmaceutical research and development.

Where has your profession journey led you?

Registered Pharmacist (New York and Vermont) to Liquids and Semisolids Formulator (Albany) to Stabilitarian, to QC Manager to QA Administrator (Philadelphia) to Corporate Quality Systems Steward (Boston) to Associate Director of QC Stability (San Francisco/Albany) to Stability Information Specialist (Osaka/Albany).  I’ve been privileged to work with Pharmaceuticals, Medical Devices, Biologicals and Stability Equipment; having a hand in developing products that have been used by just about everyone who participates in the world’s health systems.

What is your participation with PDSG and how did it begin?

I was participating in pharmaceutical meetings that sometimes briefly touched on Stability topics, and a small band of Stabilitarians joined me in wanting more interaction about our specialized field of endeavor.  In 1988, I volunteered to host a discussion meeting at my work site and that led to the founding of the Pharmaceutical Stability Discussion Group, which brings Stabilitarians together twice a year to discuss “all things Stability”.  The organization is now incorporated as a “Not-for-Profit” Association.  I serve as volunteer President and Facilitator, aided significantly by a host of Stabilitarians and my wife Christina who organizes most communication and registration activities

What do you feel your greatest challenge is in your day to day stability environment?

The danger of an overloaded system, where studies spring up like a field of wildflowers rather than a well-planned English garden.  The plethora of studies overwhelms the ability of the Stabilitarian to accommodate the sheer volume of data that needs to be analyzed, trended and reported.  Overcrowded chambers challenge the limits of space and good sample management.  The industry needs to return to a rational strategy where each study has a vital purpose and resources are supplied to match the need.

What advice would you give novice professionals entering the field?

Participate in Stability workshops, seminars and discussion groups.  Develop strong relationships with those departments and services that support the stability function at your site.

What do you do in your free time?

I like to Kayak as an easy and quiet way to see wildlife.  I also enjoy historical novels and visiting historical sites.  Most days, my wife and I can be found taking a long walk at sunset.

What’s your favorite pizza topping?

All of them, but if you were to take them away, I would beg you to spare the tiny meatballs.

Biography of John O'Neill, MS, RPh.

John O’Neill is currently Associate Director of QC Stability with Regeneron in Rensselaer, NY.  John received his B.S. degree in Pharmaceutical Sciences from Columbia University and his M.S. in Health Systems Management from Union University.  In addition to having been a CVS pharmacist and independent consultant, he has served in formulation, stability and quality management roles at Sanofi (pharmaceuticals), Boston Scientific (medical devices), Gilead Sciences and Genentech (Biologicals).  

John is the founder and facilitator for the Pharmaceutical Stability Discussion Group (PSDG) in addition to serving /having served in the stability working groups of the International Pharmaceutical Federation, (FIP), American Society for Testing and Materials (ASTM) and the Product Quality Research Institute (PQRI).




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