*Applications will be reviewed on a rolling-basis.

A research opportunity is available in the Office of Biotechnology Products (OBP), Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), located in Silver Spring, Maryland. 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 FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

The project will focus on evaluation of the impact of influenza polymerase mutations on susceptibility to the antiviral activity of baloxavir marboxil, a recently FDA-approved endonuclease PA inhibitor of influenza A and B viruses. Determination of the amino acid substitutions by which influenza viruses become resistant is critical for drug development, clinical use, and public health. Results from this research project will help to predict which baloxavir-resistant influenza viruses may emerge under treatment.

Under the guidance of the mentor, the selected participant will learn about the development and validation of in vitro models to characterize antiviral drug products and will learn about the advantages and limitations of the different models. The participant will be encouraged to use state of the art technologies to analyze complex data and to engage in critical mechanistic thinking.

Anticipated Start Date: 2022. The start date is flexible and will depend upon a variety of factors.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA.  OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

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 obligation to protect and not to further disclose or use non-public information.

The qualified candidate should have received a bachelor’s, master’s, or doctoral degree in one of the relevant fields, or be currently pursuing a master’s or doctoral degree. Degree must have been received within five years of the appointment start date.

Knowledge of in vitro cell culture models used for studying infectious agents, microbiological techniques, such as PCR, side-direct mutagenesis, cloning, and modeling therapeutic treatment of viral infection is preferred.