Operations Executive Profile: Shawn Fitzpatrick

Pharmaceutical Manufacturing sits down with Shawn Fitzpatrick, Associate director of manufacturing-bioreactor operations, Shire Plc

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How did you get started in the biopharma industry?

I grew up in South Boston, Massachusetts, which at the time was a close-knit neighborhood. Movies made in recent years such as Good Will Hunting, Gone Baby Gone, The Departed and Black Mass and so on accurately depict the neighborhood I grew up in. Typical career paths included blue collar jobs such as a trade or fire/police or other avenues that could land you in jail.

After high school, I had no idea what I wanted to do. I tested the waters in several professions in order to find my way. My schooling included culinary arts college for a couple of years when I thought I was going to be a baker, followed by EMT training and even bartending school. One day in 1996 my mom found an ad in the Boston Globe for the JAS (Just-a-Start) Biomedical Careers program.

I always liked science and thought, why not? I applied, interviewed, and was eventually accepted into the program. It was something new and exciting and I learned a lot going through the program. I worked a full-time job in a kitchen nursing home at night while trying to find the time to study, which was typically getting to class an hour or two early every day in order to do my homework. I made it through, graduated from the program around nine months later, and the job search began.

Coming out of school I landed my first job as a manufacturing technician in cell culture at Serono Laboratories and worked there for a little over a year until the plant was shut down and I was laid off. I dipped my toes into research a bit with my second job at Genetic Institute, but the program was eventually terminated and I was laid off again. I began to wonder if I made the right move going into biotech. I eventually landed at Transkaryotic Therapies Inc. (TKT) in June of 1999. I started as a manufacturing technician and worked my way up the chain, eventually becoming a supervisor. In 2005, Shire acquired TKT and my journey continued.

In my nearly 17 years at the company, I’ve worked in numerous roles supporting the startup of our three internal manufacturing sites in Massachusetts. My current role is Associate Director of Manufacturing- Bioreactor Operations. One thing I can say of my time here is that I’ve never been bored! Along the way I realized that I wanted to finish my education — of course, while I was married with one child and another one on the way. I began night courses in business at Becker College, which were held every Wednesday night from 6-10 p.m. This was a bit of a juggling act — working, raising our kids, going to school and studying. I would be lying if I said it wasn’t a little stressful during this time. But I’m proud to say that I graduated in 2014 with a Bachelor’s Degree in Business Administration.

As part of giving back, I sit on advisory boards for local high schools that offer a biotech program, as well as some local community colleges. I was recently appointed to be on the board of directors at the Just-A-Start Corporation, which was a great honor coming from their Biomedical Careers program that helped launch my career.

Are there any defining moments you’ve experienced in daily operations you’d like to share?

Back in April of 2005, Shire had just announced the acquisition of TKT; about 2-3 days after the announcement the manufacturing plant (the only one) caught fire. First of all, thankfully no one was hurt. It felt as if it was my own house going up in flames as I was there from the time the facility started up. Plus, it was our only manufacturing plant producing clinical and commercial products.

The team as a whole pulled to together to get the plant back into operations. This required cleaning and repairing equipment along with some level of construction activity. It didn’t matter what level or group you were in — everyone pulled together to get the plant back on line. Technicians and senior directors were working side by side cleaning equipment, discarding materials, etc. I’m proud to say we had the plant back online in roughly two months. The response from everyone working there was something I still reflect back on today. I often share this story with staff today as an example of teamwork and what can be accomplished by sharing a single goal and going after it.

What do you think is one of the biggest challenges — specific to manufacturing — that the industry faces?

There are many challenges specific to manufacturing from changing regulations to competition. I think one of the biggest challenges that the industry is facing is ensuring there are more individuals coming out of school that are job-ready. Working in a cGMP environment is very regulated and will require training for anyone that is hired. Having some basic knowledge/exposure to cGMP manufacturing, compliance, operational excellence, SOPs, and working in a cleanroom are core items that most students coming out of school don’t have, but should. I believe there is more that industry can do by partnering with these schools/universities to ensure that the needs of the industry are reflected in the coursework students have. Industry can accomplish this when people like me volunteer to be part of an advisory board to develop curriculum for students. Companies can also donate up-to-date equipment so that students are familiar with what they will see when they enter the job force, give students the opportunity to tour manufacturing sites and also offer internships.

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