To submit your application, scroll to the bottom of this opportunity and click APPLY.

A complete application consists of:

• An application
• Transcripts – Click here for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity in your email.

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is currently available at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.

The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services. CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.

Research Project: This project will establish science-based approaches for immunological characterization of allergenic products and evaluation of food allergy immunotherapies. Through in vitro immunoassay development, analysis of immune responses to allergenic products, biomarker validation, and assessment of immunotherapy mechanisms, the project will generate evidence that supports risk assessment, product standardization, and regulatory decision-making for food allergy diagnostics and therapeutics. Currently, the lack of standardized immunological assays and validated biomarkers limits the ability to assess allergenic product consistency, predict immunotherapy outcomes, and evaluate safety and efficacy of emerging treatments. This research aims to improve FDA-regulated product quality, safety, and efficacy for individuals with IgE-mediated food allergies requiring diagnostic or therapeutic intervention. The specific projects include:

1. Development of in vitro and in vivo assays for immunological evaluation of GRAS substances and allergenic excipients using animal food allergy models and animal surrogate technologies to assess immunogenicity and safety profiles.
2. Development of modification-resolved IgE analysis methods to enhance allergenic product safety through improved allergenic product potency testing, enabling more accurate dose determination, establishment of clinical endpoints, and therapeutic monitoring of patient responses.
3. Investigation of novel immunotherapy approaches for food allergy treatment, including mechanistic studies of immune cell engagers and chimeric allergen receptors designed to redirect immune responses and modulate allergic reactions.

These projects will generate data on excipient immunogenicity, IgE-based biomarkers, and innovative therapeutic mechanisms, supporting regulatory evaluation of food allergy diagnostics and treatments.

Learning Objectives: You will develop understanding of immunological principles underlying food allergy and allergenic product characterization. Through hands-on laboratory experience, you will gain proficiency in advanced immunological assays including ELISA-based potency testing, modification-resolved IgE analysis, and cellular/tissue immunogenicity assessments using flow cytometry and super-resolution microscopy. You will learn to apply bioinformatic and statistical tools to analyze immunological datasets including DNA/RNA sequencing and mass spectrometry and interpret biomarker profiles. Training will include structured mentorship, laboratory research, seminars, and engagement with FDA's scientific community. You will apply acquired knowledge to support regulatory science and produce scholarly publications and scientific presentations. This experience offers valuable exposure to FDA operations.

Mentor: The mentor for this opportunity is Alexander S. Zhovmer (Alexander.Zhovmer@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: May 1, 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.

The qualified candidate should be currently pursuing or have received a doctoral degree in the one of the relevant fields. 

• Citizenship: LPR or U.S. Citizen
• Degree: Doctoral Degree.
• Discipline(s):
  • Life Health and Medical Sciences (51 )

I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
and
I have read the FDA Ethics Requirements.