What are the responsibilities and job description for the FDA Research Opportunity - Influenza Vaccine Assay Development position at Zintellect?
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is currently available in the Office of Vaccines Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland. 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: The development of vaccines against viral diseases that are major public health concerns is a high priority and is facilitated by an understanding of how the immune system provides protection against such diseases, as well as the development of improved methods to characterize new candidate vaccines and to measure and evaluate vaccine immunogenicity. The research program of the laboratory has a major focus on pandemic influenza vaccines with the aims of:
- Identifying and evaluating viral antigens and vaccination strategies that are important for the development and enhancement of protective immunity following vaccination; and
- Developing tools to measure and evaluate relevant biomarkers of vaccine immunogenicity.
Learning Objectives: Under the guidance of a mentor, you will develop improved assays for quantifying the potency of pandemic influenza vaccines, and continue efforts to optimize fast reliable processes to produce the reagents (monoclonal antibodies, and polyclonal sera) needed for these assays. In addition, these pandemic influenza virus reagents will be used to assess antibody responses, define epitopes and understand the rules of antibody immunodominance for influenza viruses with pandemic potential. This study will facilitate development, evaluation, and availability of pandemic influenza vaccines and inform strategies for improved future vaccine approaches. You will be trained in classic virology, molecular biology, and protein analysis techniques. You will gain an understanding of protein expression systems, protein structure and purification.
Mentor: The mentor for this opportunity is Jerry Weir (Jerry.Weir@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: 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.
Citizenship Requirements: This opportunity is available to U.S. citizens and, Lawful Permanent Residents (LPR).
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.