What are the responsibilities and job description for the FDA Fellowship - Development and Evaluation of Pertussis Functional Antibody Assays position at Oak Ridge Institute for Science and Education?
Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CBER-2026-0053
How To Apply
To submit your application, scroll to the bottom of this opportunity and click APPLY.
A Complete Application Consists Of
If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity in your email.
Application Deadline
6/19/2026 3:00:00 PM Eastern Time Zone
Description
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 focuses on the development, optimization, and validation of functional antibody assays to evaluate immune responses to Bordetella pertussis. This will support ongoing efforts to better characterize vaccine-induced immunity and assess functional correlates of protection beyond standard binding antibody measurements.
If selected, you will contribute to laboratory studies involving bacterial culture, cell-based assays, and quantitative immunologic methods to measure functional antibody activity.
Learning Objectives: Under the guidance of a mentor, you will have the opportunity to:
Anticipated Appointment Start Date: May/June 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, 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.
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.
Education
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:
The qualified candidate should have received a master's degree in one of the relevant fields. Degree must have been received within the past five years.
Preferred Skills
$71,244.00 – $80,412.00 Yearly
Point of Contact
Ashley
Eligibility Requirements">4 )
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CBER-2026-0053
How To Apply
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
If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity in your email.
Application Deadline
6/19/2026 3:00:00 PM Eastern Time Zone
Description
- Applications will be reviewed on a rolling-basis.
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 focuses on the development, optimization, and validation of functional antibody assays to evaluate immune responses to Bordetella pertussis. This will support ongoing efforts to better characterize vaccine-induced immunity and assess functional correlates of protection beyond standard binding antibody measurements.
If selected, you will contribute to laboratory studies involving bacterial culture, cell-based assays, and quantitative immunologic methods to measure functional antibody activity.
Learning Objectives: Under the guidance of a mentor, you will have the opportunity to:
- Learn the immunological basis of vaccine-induced protection against Bordetella pertussis, including functional correlates of immunity.
- Learn to develop, optimize, and validate functional antibody assays that measure protective immune responses beyond standard binding assays.
- Learn to perform and refine bacterial culture techniques and cell-based assays for evaluating antibody-mediated activity.
- Learn to apply quantitative immunologic methods to assess functional antibody responses.
- Learn to design rigorous laboratory experiments and analyze data to support vaccine evaluation efforts.
- Learn to interpret functional immune response data in the context of vaccine performance and public health impact.
Anticipated Appointment Start Date: May/June 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, 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.
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.
Education
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 master's degree in one of the relevant fields. Degree must have been received within the past five years.
Preferred Skills
- Experience handling nasal samples and blood samples from NHPs and Humans
- Experience performing ELISAs, Serum bactericidal Assays and opsonophagocytic assays
- Experience with GLP, GDP, and GCLP documentation
- Experience with primary T-cell culture
- Experience culturing Bordetella pertussis
$71,244.00 – $80,412.00 Yearly
Point of Contact
Ashley
Eligibility Requirements">4 )
- Degree: Master's Degree received within the last 60 month(s).
- Discipline(s):
- Life Health and Medical Sciences (
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Salary : $71,244 - $80,412