FDA Fellowship - Rapid Sterility Testing Innovation: Evaluating ATP-Bioluminescence Technology

Reference Code

FDA-CDER-

U.S. Food and Drug Administration (FDA)

A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), located at White Oak, Maryland. The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over‑to‑counter and prescription drugs, including biological therapeutics and generic drugs.

These efforts cover more than just medicines.

• Applications will be reviewed on a rolling basis.

The participant will engage in a research initiative aiming to improve the Agency's understanding of ATP‑bioluminescence technology, which has been identified as a rapid microbial method that aligns with current pharmaceutical industry trends, to better support submissions utilizing this approach. Researching collaboratively with FDA scientists, the participant will cultivate and maintain approximately 10‑12 biosafety level 1 and level 2 bacteria species that will be subject to the novel ATP‑bioluminescence testing methods.

The participant will inoculate relevant biomanufacturing process fluids with bacteria species to determine potential matrix interference and assay limitations. Results from this study will be reported to the cross‑center Rapid Sterility Testing WG. Findings can be used in support of regulatory risk‑based assessments and provide scientific basis for guidance on the use of commercially available ATP‑bioluminescence detection system for microbial testing of biologic products.

• Upon completion, you will gain proficiency in USP microbiological laboratory research as well as a thorough understanding of the regulatory requirements for sterility and bioburden testing.
• You will develop expertise in Biosafety Level 1 and Level 2 cell handling, sterility testing, bioburden testing, and novel ATP‑bioluminescence technologies.
• Learning outcomes include structured training in applied regulatory science, linking process understanding of novel manufacturing technologies to evolving regulatory expectations. You will gain experience in hands‑on microbiological research, performing quantitative colony counting, ATP‑bioluminescence data analysis with respective commercial software, and understanding the impact of biomanufacturing process buffers on microbiological recovery and detection.

Scott Lute (scott.lute.gov). If you have questions about the nature of the research, please contact the mentor.

May/June 2026. Start date is flexible and will depend on a variety of factors.

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

The appointment is full time.

The participant will receive a monthly stipend commensurate with educational level and experience.

This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non‑U.S. citizen applicants should refer to the Guidelines for Non‑U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:

• Non‑employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;
• ORISE fellow’s…