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  1. Science & Research

Thilak Mudalige, PhD, Research Chemist

Thilak Mudalige, PhD, Research Chemist

"I’m still fairly early in my career, and yet I’m invited to speak at international scientific conferences and to serve as a reviewer for prestigious scientific journals. My accomplishments are recognized by FDA, and, at end of the day, I love what I do." -- Dr. Thalik Mudalige, Research Chemist.


Thilak Mudalige, PhD

Q: Why do you think a scientist should consider FDA as a place to work?

Thilak Mudalige: FDA is a very unique organization that addresses one of the things that matters most in everyone’s life—consumer safety. I work in FDA’s Office of Regulatory Affairs (ORA), which is responsible for postmarket regulation as well as investigating consumer complaints about the negative health effects of regulated products.

In ORA, where I’m a research chemist, we’re responsible for identifying and quantifying trace amounts of hazardous contaminants or adulterants in products with very complex matrixes. It’s kind of like finding a needle in a haystack but I find it very rewarding. We have to adapt, modify, and validate existing analytical methods or invent new methodologies for the analysis.

The results of our efforts are published in peer-reviewed journals that get national and international recognition. I’m still fairly early in my career, and yet I’m invited to speak at international scientific conferences and to serve as a reviewer for prestigious scientific journals. My accomplishments are recognized by FDA, and, at end of the day, I love what I do.

At FDA you’ll meet many scientists with international backgrounds like myself. I grew up in rural Sri Lanka, where we didn’t know much about regulations and their importance. As farmers, we grew our own food and were self-sufficient. We used indigenous medicine, based on medicinal plant extracts. So when I came here, I was shocked to see the diversity of the U.S. market and the complexity of consumer products that are imported from around the globe. When I learned that FDA regulates 20% of the consumer products in United States I dreamed of working for such an agency. The FDA Commissioner’s Fellowship Program opened the door to the agency for me.

Q: Why do scientists like you stay at FDA?

TM: Few people stop to think about the broad range of products that they use every day that FDA regulates. Emerging technologies like nanotechnology are being used or applied in the development of these products. FDA scientists like me face enormous challenges in keeping up with, managing, and understanding these latest discoveries so that we can accurately assess their safety and efficacy. The opportunity to learn about new technologies is exciting and also supported at FDA through training and developmentORA University (ORAU) is unique training program for ORA employees, where they learn regulatory science. FDA also offers job security for a scientist as well as recognition, and an incentive for performance-based promotional potential through the peer review process.

Q: How do you use your science degree at FDA?

TM: In ORA we develop validated analytical methodologies for postmarket regulation of FDA products. The cutting-edge experimental techniques I learned as a chemistry graduate student at Western Michigan University and as a postdoctoral research associate at Brookhaven National Laboratory gave me a strong scientific foundation for my work at FDA. It enabled me to act as a subject matter expert in building the state-of-the-art nanotechnology core facility at FDA’s Jefferson Labs. I develop methodologies for the physical and chemical characterization of nanomaterials in FDA-regulated products. My previous experience trained me to look at a scientific issue with an “outside-the-box” mindset.

Q: How is science conducted at FDA unique from science conducted at the National Institutes of Health, academia, or industry?

TM: Research conducted at FDA occupies a niche that complements the spectrum of research conducted in academia, industry and in other governmental agencies like NIH. Research conducted in ORA is focused on developing techniques for evaluating FDA-regulated products and improving their safety. We focus on analyzing products already available on the market to verify product quality and label accuracy. For example, by developing techniques that quantify nanoparticles in commercial sunscreens we can ensure that they are appropriately labeled for consumers.