'Sold’ on Service to the Nation

Rivera Rosado guides efforts toward new drug approvals at the FDA.

Published in Hopkins Medicine - Spring/Summer 2021

It was soon after starting work as a postdoctoral fellow at the U.S. Food and Drug Administration, on the campus of the National Institutes of Health, that Leslie A. Rivera Rosado, Ph.D. ’08, noticed “seeing officers in what looked like Navy uniforms working at the NIH and at FDA labs,” she says.

Eventually she learned that the uniformed officers were members of the U.S. Public Health Service Commissioned Corps.

“My dad is a retired Army colonel, so I was always attracted to the idea of service to the nation in uniform,” she recalls. The idea of the U.S. Public Health Service intrigued her. She went for interviews with USPHS officers at the FDA, talked to a friend who had joined the corps, and, “I was sold,” she says.

Now a lieutenant commander, the 41-year-old Rivera Rosado — who earned her Johns Hopkins Ph.D. in biochemistry, cellular and molecular biology — works in the FDA’s Center for Drug Evaluation and Research. There, she is a lead scientist in the Office of Biotechnology Products, as well as a drug shortage coordinator and subject matter expert on biologics.

In these positions, she manages the day-to-day activities of a team of scientists and oversees the assessment of product quality and pharmaceutical quality information submitted as part of Investigational New Drugs and Biologics License Applications. The work of her and her team, she explains, contributes to the approval of novel biological drugs used to treat serious medical conditions and helps ensure the drugs’ availability.

Although Rivera Rosado has not been involved in assessing the new COVID-19 vaccines, her team has provided advice to drug manufacturers on how to ensure efficient development of novel COVID-19 therapies.

And as a USPHS officer, she deployed twice in 2020 in support of the federal COVID-19 response. “Our workload has definitely increased,” she says — in a presumable understatement.