Can Stability Be a Career?

(with apologies to Richard Henry Dana Jr.)

At one point in my career, just as I was coming into my own in the Stability community, our departmental director was encouraging his managers and supervisors to envision their future paths and how to move up in their professional lives. He caught me off guard in citing me as his example: “I’m sure John doesn’t plan to spend his entire corporate life in the Stability Group”. I was hoping my expression at that moment didn’t betray my feelings that spending the rest of my days in Stability was exactly my intention and plan. He was among the many traditionally sighted executives in the pharmaceutical world that saw the Stability function as a low level, low opportunity, steppingstone to other positions with much greater horizons.

The path of a Stabilitarian can have many challenges, including administrative hurdles like the one just cited. I hope the following odyssey will encourage you on your professional journey and allow you to navigate obstacles or jump over them entirely.

As a newly minted pharmacist, a career in Stability, let alone pharmaceutical research was the last thing on my mind in 1974. Growing up in my father’s community pharmacy, I envisioned a life of filling prescriptions for the local townsfolk, but I often gazed at the labels of the bottles on the shelves, listing the names of the pharmaceutical manufacturers and their locations. Companies like Upjohn in Kalamazoo Michigan, Eli Lilly in Indianapolis Indiana and Alcon in Fort Worth Texas made me wonder what these companies looked like. Little did I suspect that one day I would stand in the halls of not only these, but dozens of others.

While applying for pharmacist opportunities post-graduation, a woman approached me after church one Sunday with a job listing for Sterling-Winthrop Research Institute in the local paper. “Wanted: Pharmacist for a position in R&D”. I had no idea what “R&D” stood for, but my “guardian employment finder” was determined that I should find out, and a month later I was wearing a starchy white lab coat working as a Liquids and Semi-solids Formulator and loving every minute of it. It was a great opportunity to learn about excipients, diluents, preservatives and their impact on product stability. Filling the pages of my laboratory notebook were the emerging formulas of products such as Campho-Phenique Gel, Demerol Syrup and Neo-Synephrine Nasal Spray. Formulation was a best educated guess trial and error affair that often sent the Formulator back to the drawing board just a few months into something called a stability study. I learned that I would much rather be the one who put a proposed product through the rigors of a stability protocol than to be the one responsible for reformulation under a tight deadline.

After completing a master’s degree in health systems management, I jumped at the chance to help form the company’s first official stability group and through an introduction by one of our corporate officials, was soon off to meet with one Bob Barraza, Stability Supervisor Extraordinaire for Burroughs Wellcome (now GSK) in North Carolina. He became a great mentor and longtime industry friend, and I’ve forever appreciated his willingness to spend time with me and sharing the rudiments of the Stability Function. I started reading industry journals for any articles that even mentioned Stability and soon discovered my professional heroes like Gary Dukes, Carol Easter and others. Like the companies named on the bottles in dad’s drug store, I never dreamed of meeting these people, let alone becoming their industry colleague.

As years passed, I attended Industry events such as the annual Pharmaceutical Manufacturer’s Association Meeting (No AAPS or KENX back in those days) and always looked forward to a one-hour interactive discussion session among Stability Supervisors. We all felt that one hour per year for such a discussion was far too little and in a moment of uncharacteristic boldness, I volunteered to get permission to host a one day “Stability Meeting” at my company. Soon after, seven Stability managers from east coast pharmaceutical companies came together and the sharing of challenges, solutions and best practices resulted in a unanimous desire to meet regularly and invite others. As host, I had chaired the discussion, not realizing that day I had been appointed “Facilitator for Life”. Thirty-eight years later, hundreds of companies and thousands of individuals (including those previously mentioned heroes and one Wolfgang Grimm, founder of ICH) have participated in what has become the Pharmaceutical Stability Discussion Group (PSDG). Bringing people together over the course of a couple hundred meetings to exchange best practices and share experiences for the success of their stability programs took me into many of those venerable pharmaceutical halls envisioned in my community pharmacy days.

In recent years, following a path of incremental retirement, I established StabilityHub and the monthly newsletter that it distributes via e-mail. The mission of the site and newsletter opens the PSDG concept to all who are interested in stability-related information on a round-the-globe, round-the-clock basis. The Pandemic of 2020 has made this transition from all in-person events to website/newsletter/webinars a timely and fortunate move.

Participation in industry organizations such as PSDG and American Association of Pharmaceutical Scientists (AAPS) as well as presenting at/attending seminars such as KENX’s Laboratory University enables Stabilitarians to meet others, develop their skills and gain industry leadership roles. The accumulation of knowledge and exposure to a wide range of influential individuals can bring advancement and open doors to corporate transition as well.

Transitions indeed came my way; some by pull, others by push. An early retirement after 33 years at Sterling-Winthrop/Kodak/Sanofi to lead a newly formed Stability Group at Boston Scientific opened the way to 5 years’ experience with Medical Devices. A lay-off led to industry colleagues tracking me down to open up the fascinating world of consulting, with stints in Greenville South Carolina, Cleveland Ohio, and Hyderabad/Mumbai India. A call from Gilead in Foster City California from yet another industry colleague took me to my highest title in leading a Stability group processing high profile state-of-the-art products.

The fickle finger of fate saw my department laid off several months later and an industry colleague picked up three of us for a busy Biotech stability group at nearby Genentech. This latest move accomplished a rare career trifecta: Pharmaceuticals, Medical Devices, and Biotechnology. At Genentech I helped with two products that are still in high demand today. Two years later, east coast Regeneron recruited me as Associate Director for QC Stability and yet two more prominent products rolled out the door before I rolled out with them at the end of my corporate career.

Again, exposure through PSDG participation was responsible for my next move as I was recruited to consult for a Japanese stability chamber manufacturer. Successively, two more companies reached out for stability consulting and over the last several years a professional education provider as well as KENX seminars have kept me busy in parallel with StabilityHub.

The Stability Function can provide an active, interesting and rewarding career. As opportunity and talent permit, going beyond the walls of your stability area in participation with stability-focused organizations such as PSDG, AAPS, KENX Laboratory University, Cobblestone, and others can bring you professional growth, recognition, and advancement opportunities. Take every opportunity to network and serve outside of your corporate walls. Find your heroes and reach out to them. They were once in your shoes. “Stability” can indeed be an enduring career if you are willing to become part of the close knit Stability community, roll with the vagaries of lay-offs, firings, and corporate initiatives, and move around to catch the next wave for advancement.

At the 50-year mark, it is time for me to take a further leap into retirement, stepping back from all professional activities, save a still rigorous participation in the workings of StabilityHub. A kayak, some smallmouth bass and a garden full of tomatoes and peppers are calling my name.

There isn’t room in this article to delve into the specific challenges, pitfalls and tricks of the stability trade, but you can find many of these in two previous articles, linked below.

• Building Your Best Stability Career
• Ten Things Every Stabilitarian Should Know

Best of luck for your Stability career,

John O’Neill, Stabilitarian