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Ensuring drug safety: A chemist in regulatory affairs

Profile: Olen Stephens, Ph.D. chemist, chemical and manufacturing controls reviewer at the Food and Drug Administration.

Olen Stephens (center), with his two sons, Sean (left) and Coby (right). Courtesy photo.

A few weeks back, Glen wrote a post about a website, INSPIRE, which is chock-full of information about government jobs for scientists. If you haven’t yet, check it out here. There’s still time to take the survey that will help them improve their site.

As promised, here is the first of two profile posts about chemists currently working for the federal government. Today I’d like you to meet Olen Stephens, a Ph.D. chemist who works in regulatory affairs.

From academia into government

Olen Stephens always thought he wanted to be a college professor, but after giving it a try, he realized it wasn’t the job for him.

Now he works in regulatory affairs at the Food and Drug Administration (FDA) and says he loves his job and the work-life balance it allows him.

I should also mention that Olen and I share a family connection. He’s my mother-in-law’s sister’s son, a.k.a. my husband’s cousin!

Olen was a double major in chemistry and biology at Earlham College and went on to get a Ph.D. in biological chemistry from the University of Utah (2004). After a postdoc in biophysical chemistry at Yale University, he landed a tenure-track professorship position at his alma mater, Earlham College.

As a chemistry professor, Olen taught organic chemistry, biochemistry and general chemistry. But the job was “not a good fit on either side,” he says.

“Teaching wasn’t what I thought it was,” Olen says. The combination of teaching, grant writing, and conducting research left little time to spend with his wife and newborn son.

At the same time, Olen says he wasn’t interested in working in industry either.

In his first year teaching at Earlham, Olen met another Earlham alumnus who worked at the FDA.  Later, when Olen was looking for a career change, she told him about a position they were looking to fill. Five months later, Olen had landed the job and his family moved to the Washington, D.C. area, and the rest is history.

Regulatory affairs– What’s that all about?

Olen has been working as a chemical and manufacturing controls reviewer since 2008 and finds his career both challenging and rewarding.

At the FDA, Olen works as part of a team to review drug applications and identify safety issues that need to be addressed before drugs can be administered to humans.

The job requires a lot of reading and writing, which Olen says he enjoys and was well-equipped for, thanks to the liberal arts education he received at Earlham as an undergrad.

There was a huge learning curve when he first started, but Olen says everyone at the FDA was very willing to help him get up to speed on the pharmaceutical know-how needed for the job.

“You just have to put your pride aside and ask questions,” Olen says.

In contrast to industry, Olen says, there’s no incentive to try to get the product out the door and onto the market to make money. The FDA makes no money off of drugs and is simply there to make sure that drugs used in clinical trials or market are both safe and effective. Olen says he finds this particular aspect of his work uncomplicated and gratifying.

It’s also nice to not have the pressure of “publish or perish” that prevails in academia, he adds.

In regulatory affairs, your primary concern is drug safety and efficacy, not how much money the drug will make on the market. Photo credit: Wikimedia Commons user Ragesoss.

“It’s great for family life,” says Olen, who rarely has to take work home and can telecommute from home up to two days a week. On the other days, he bikes 4 miles each way between his house and his office.

While he does miss being in the lab, Olen says he recognizes that if he were to have a research job he wouldn’t be able to keep the hours he wants.

But his job isn’t limited to being an office job. There are opportunities for scientists in regulatory affairs to apply for funding in collaboration with academic research labs.

Getting a Ph.D. in chemistry isn’t the only way to get a job in regulatory affairs—Olen says many of his colleagues come from chemical engineering or pharmacy degrees, and others come into the job with several years of experience in the pharmaceutical industry under their belts.

And there are plenty of other jobs in the FDA for Ph.D. chemists, Olen says, both research and non-research positions. Sounds like blog fodder for future JAEP posts… :)

Olen says to succeed in regulatory affairs, you need to “work well with people, be willing to listen and communicate effectively,” because your feedback on drug applications is crucial to helping companies and research labs develop safe and effective treatments.

To search for government job openings, visit www.usajobs.gov. And don’t forget to check out the new government website that is now being piloted, INSPIRE, and offer them feedback through their online survey.

Most importantly, Olen recommends you make connections, or dare I say network, with people who work in government labs to learn more about job opportunities you may qualify for.

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