FDA Postdoctoral Fellowship - Applied Regulatory Science Immunology
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 (kristina.howard@fda.hhs.gov). 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.
Program Information
The 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.
Background Investigation
A successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA.
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.
Qualification Requirements
The qualified candidate should be currently pursuing or have received a doctoral degree in the one of the relevant fields (biological sciences; with emphasis in immunology, toxicology, and/or cell biology preferred).
Citizenship: LPR or U.S. Citizen
Degree: Doctoral Degree.
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.)
I have read the FDA Ethics Requirements.
Contact Information
To submit your application, scroll to the bottom of this opportunity and click APPLY.
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.
Connect with ORISE…on the GO! Download the new ORISE GO mobile app in the Apple App Store or Google Play Store to help you stay engaged, connected, and informed during your ORISE experience and beyond!