What are the responsibilities and job description for the FDA Fellowship in Immunogenicity of Therapeutic Proteins position at Oak Ridge Institute for Science and Education?
Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CBER-2026-0091
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.
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!
Application Deadline
12/18/2026 3:00:00 PM Eastern Time Zone
Description
CBER’s mission is to ensure the safety, purity, potency, and effectiveness of biological products including vaccines, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury.
Research Project: There is an opportunity for a post-master’s or post-doctoral fellow in the laboratory of Zuben E. Sauna. You will have the opportunity to learn how in silico, in vitro and ex vivo tools are used in the assessment of the unwanted immunogenicity of protein products. The project will employ a variety of approaches from the following disciplines: cell and molecular biology, computational biology, biochemistry and immunology.
You will join a research program that broadly investigates unwanted immune responses to proteins used in therapeutic applications. The specific focus will be immune responses to therapeutic proteins and Cas proteins used in gene editing. Cas9 proteins derived from human pathogens are the most extensively studied CRISPR-Cas gene editors. An important hurdle when developing and licensing a protein for clinical applications is the potential for immune responses to the protein. We have previously demonstrated both T- and B-cell immunity to diverse Cas proteins. You will develop new tools to understand the safety consequences of immune responses to diverse Cas proteins as well as neo-epitopes generated due to off-target gene editing.
The following articles from our laboratory provide examples of research performed in our group:
Mentor: The mentor for this opportunity is Zuben Sauna (Zuben.Sauna@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: 2026/2027. 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 or doctoral degree in one of the relevant fields (e.g. Immunology, Biochemistry, Biology, Pharmaceutical Sciences, Bioinformatics, Computational Biology) or be currently pursuing one of the degrees with completion before the appointment start date. Degree must have been received within five years of the appointment start date.
Preferred Skills
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U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CBER-2026-0091
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.
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!
Application Deadline
12/18/2026 3:00:00 PM Eastern Time Zone
Description
- Applications are reviewed on a rolling-basis and applications may close before the deadline.
CBER’s mission is to ensure the safety, purity, potency, and effectiveness of biological products including vaccines, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury.
Research Project: There is an opportunity for a post-master’s or post-doctoral fellow in the laboratory of Zuben E. Sauna. You will have the opportunity to learn how in silico, in vitro and ex vivo tools are used in the assessment of the unwanted immunogenicity of protein products. The project will employ a variety of approaches from the following disciplines: cell and molecular biology, computational biology, biochemistry and immunology.
You will join a research program that broadly investigates unwanted immune responses to proteins used in therapeutic applications. The specific focus will be immune responses to therapeutic proteins and Cas proteins used in gene editing. Cas9 proteins derived from human pathogens are the most extensively studied CRISPR-Cas gene editors. An important hurdle when developing and licensing a protein for clinical applications is the potential for immune responses to the protein. We have previously demonstrated both T- and B-cell immunity to diverse Cas proteins. You will develop new tools to understand the safety consequences of immune responses to diverse Cas proteins as well as neo-epitopes generated due to off-target gene editing.
The following articles from our laboratory provide examples of research performed in our group:
- V.L. Simhadri, P. Bajgain, S. Vijayanand, W. Jankowski, A. Rawal, L. Thijs, T. Van Doninck, K. Boonen, S. Pattyn, E. Pepermans, Z.E. Sauna. Pre-existing antibody and T cell responses to SaCas9, AsCas12a and CasF are comparable in naïve individuals. Nat Commun. 17: 8166, 2026.
- V.L. Simhadri, Vijayanand, V. Jawa, Z.E. Sauna. Immunogenicity risk assessment of novel modalities using new approach methodologies. Nat. Rev. Drug Discov. In Press, 2026.
- V.L. Simhadri, J.R. McGill, & Z.E. Sauna. Endotoxin contamination in commercially available Cas9 proteins potentially induces T-cell mediated responses. Gene Therapy. 2022
- V.L. Simhadri, L. Hopkins, J.R. McGill, B.R. Duke, S. Mukherjee, K. Zhang, & Z.E. Sauna. Cas9-derived peptides presented by MHC Class II that elicit proliferation of CD4( ) T-cells. Nat. Commun. 12: 5090, 2021
- J.R. McGill, O.N. Yogurtcu, H. Yang, D. Verthelyi, & Z.E. Sauna. SampPick: Selection of a cohort of subjects matching a population HLA distribution. Front. Immunol. 10: 2894, 2019
- V.L. Simhadri, J. McGill, S. McMahon, J. Wang, H. Jian & Z.E. Sauna. Prevalence of Pre-existing Antibodies to CRISPR-associated Nuclease Cas9 in the US Population. Mol Ther Methods Clin Dev. 10: 105-112, 2018
Mentor: The mentor for this opportunity is Zuben Sauna (Zuben.Sauna@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: 2026/2027. 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 or doctoral degree in one of the relevant fields (e.g. Immunology, Biochemistry, Biology, Pharmaceutical Sciences, Bioinformatics, Computational Biology) or be currently pursuing one of the degrees with completion before the appointment start date. Degree must have been received within five years of the appointment start date.
Preferred Skills
- Experience in advanced techniques in immunology, biochemistry, molecular biology, cell biology
- Experience in Bioinformatics, Applied Statistics, Computational Biology
- Willing to learn new technologies and methods and operate outside their comfort zone is a desired quality in the applicant
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Eligibility Requirements">12 )
- Degree: Master's Degree or Doctoral Degree received within the last 60 months or currently pursuing.
- Discipline(s):
- Chemistry and Materials Sciences (
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