FDA Postdoctoral Fellowship - Applied Regulatory Science Immunology

•Applications will be reviewed on a rolling-basis.

FDA Office and Location:

A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), located at Silver Spring, 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-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines.

Research Project:

You will be involved in the immunogenicity testing of therapeutic protein drug products, including biosimilars and generics, that are of regulatory significance to CDER using in vitro techniques. In addition, novel approach methodologies (NAMs) for immunosafety assessment will be evaluated. You will be involved in the following aspects of the project: Experimental design, testing and assessment of biologics, biosimilars and generics Multi-parameter flow cytometry ELISA (MSD & Luminex), ELISpot, cell isolation & culture Developing/testing of immunosafety NAMs Data analysis, literature review, and manuscript preparation

Learning Objectives:

The fellowship will provide you with training in a range of immunological techniques that will be used to assess anti-drug antibody responses and other immunosafety issues.

Mentor:

The mentor for this opportunity is Kristina Howard ( ). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date:

September 2026. Start date is flexible and will depend on a variety of factors.

Appointment Length:

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

Level of Participation:

The appointment is full time.

Participant Stipend:

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

Citizenship Requirements:

This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only. 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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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 Ethics Requirements If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists . 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.