by: Zachary Fritz
The U.S. Food and Drug Administration (FDA) is recognizable to most biomedical science graduate students as a lynchpin of the pharmaceutical industry that ensures our medicines, vaccines, and medical devices are safe, effective, and manufactured through the proper channels. Many grad students might not realize that the FDA also provides a wealth of deeply rewarding and meaningful career opportunities. On November 2nd, the iJOBS Program’s “Careers at the FDA” panel brought together five Rutgers University graduate school alumni to discuss their jobs, career prep advice, and what it means to work at this agency.
The wide array of departments within the FDA was on full display, with each panelist having very different duties and areas of focus. Dr. Katie Sokolowski is a senior toxicologist in the Division of Pharmacology/Toxicology for Neuroscience at the Center for Drug Evaluation and Research (CDER), where she primarily does nonclinical (e.g. animal studies data) risk assessments on both Investigational New Drug and New Drug applications. Dr. Kathryn Drzewiecki, a policy officer and project manager in the Center for Devices and Radiological Health, is responsible for drafting and reviewing policy documents related to medical devices as well as overseeing various processes within the department. Dr. Fanfan Wu was the one panel member whose work centered around food safety rather than pharmaceuticals or devices. As a visiting scientist in the Center for Food Safety and Applied Nutrition (CFSAN), she conducts consumer outreach research via surveys and focus groups to gauge public opinion on FDA policy, such as the layout and content of nutrition facts panels. Dr. Andrea Gray is a biomedical engineer in the Center for Biologics Evaluation and Research and provides regulatory review on the safety and manufacturing methods of proposed cellular therapies and related devices. The most recent FDA hire on the panel, Dr. Anika Haq, is an Oak Ridge Institute for Science and Education (ORISE) fellow at CDER. She does a combination of reviewing generic drug applications, primarily for topical and transdermal treatments, as well as carrying out her own research into in silico models of skin-based drug delivery.
The modern FDA's establishment can be traced back to the 1906 passage of the Pure Food and Drugs Act, a law partly meant to combat the dubious claims of so-called "patent medicines". This 1950's informational poster serves a similar purpose for misleading nutritional myths. (Image credit: FDA, https://www.flickr.com/photos/fdaphotos/albums/72157624615595535/page1)
Despite their diverse roles, many of the women on the panel shared commonalities beyond their graduate alma mater. For many of the panelists, their entry into the FDA was through a fellowship program. Both Drs. Wu and Haq are ORISE fellowship recipients, Dr. Drzewiecki was in the American Institute for Medical and Biological Engineering (AIMBE) Scholars Program, and Dr. Gray was a Commissioner’s Fellowship recipient. These fellowships serve an important role, allowing both the recipient and their supervisors at least one year to evaluate whether the fellow would be a good fit at the agency. Dr. Drzewiecki said a common career path at the FDA is starting with one of these entry fellowships before progressing to a temporary Staff Fellow position. Those temporary Staff Fellow positions include benefits and eventually develop into a permanent position. These fellowships also seem to subsume the traditional postdoc role. However, it should be noted that Dr. Sokolowski did do a postdoc at the Center for Neuroscience Research at Children’s National Medical Center before joining the FDA, essentially bypassing the fellowship route.
As for getting your foot in the door for a fellowship opportunity, the panel emphasized the need for networking and leveraging your PhD work. Potential key connections can come from a variety of places and events, so it always behooves you to be on the lookout. Each panelist had their own way of finding and leveraging their connections throughout their careers. Dr. Haq did an internship that provided her with important references for her ORISE application, so she advised attending conferences and doing an internship in a field you want to work in to build your network. Dr. Drzewiecki worked for a variety of small biotech companies when she moved to Maryland shortly after receiving her PhD and built a formidable network right in the FDA’s backyard. Dr. Wu was actually referred to the FDA by an older student in her graduate lab that recommended her for the ORISE fellowship and position. Dr. Wu’s experience as an international student and non-US citizen was not a huge obstacle for her as she developed close relationships with her network including FDA supervisors who were determined to help her stay in the country and continue working there. For many of the panel, it helped that they were able to directly apply their PhD expertise to similar projects that would ultimately be their focus at the FDA. However, Dr. Drzewiecki pointed out that specific expertise developed in various PhD projects isn’t necessarily a prerequisite. Dr. Drzewiecki’s own PhD research on collagen-based biomaterials differs greatly from the medical device applications she reviews now. Instead, she noted that her PhD gave her the problem solving and critical thinking skills she needed to succeed at the FDA. The panel was in agreement that emphasizing these and other “soft” skills, especially reading/writing and interpersonal communication, is critical for acing any job or fellowship interview at the FDA.
When asked about their work-life balance, all of the panelists agreed that the work-life and culture at the FDA is excellent. Dr. Drzewiecki felt that her schedule was very flexible and leant itself well to a good work-life balance, though she pointed out that the COVID-19 pandemic has dramatically increased her workload and hours, but this is an exceptional case. Dr. Gray highlighted the excellent benefits, such as her 12-week maternity leave that substantially improved her work-life balance. As for transitioning into the workplace with training, Dr. Sokolowski said her experience was not very formal and more of a “learn on the job” situation, though she acknowledged this may differ by department. Overall, the panelists are very satisfied with their careers at the FDA because they all feel valued and heard at their job, and that their work at the FDA truly makes a difference in improving people’s lives.
If the thought of helping safeguard America’s food and medicine appeals to you, I’d recommend reviewing the FDA’s fellowship programs as a good jumping off point. As biomedical science marches forward with ever more complex advancements that require careful review, the valuable and rewarding work done by the FDA cannot be denied.
This article was edited by Junior Editor Natalie Losada and Senior Editor Samantha Avina.