FDA Fellowship in Immunogenicity of Therapeutic Proteins

Oak Ridge Institute for Science and Education; Silver Spring (MD); Sur place; USD 36 000 - 58 000; Plein temps

Résumé du poste

FDA in Silver Spring, MD invites a post-master’s or post-doctoral fellow to study immune responses to therapeutic Cas proteins. You will apply in silico, in vitro and ex vivo approaches to assess immunogenicity in a multidisciplinary setting.

Under mentor guidance, you will join collaborative projects with academia and/or industry, gaining training in advanced techniques and contributing to safety assessments for gene-editing proteins and therapies.

Qualifications

• Master's or PhD in Immunology, Biochemistry, Biology, Pharmaceutical Sciences, Bioinformatics or Computational Biology.
• Experience with immunology techniques and computational biology tools.
• Strong analytical and collaborative research skills.

Responsabilités

• Learn in silico, in vitro and ex vivo methods to assess immunogenicity of protein products.
• Develop tools to understand immune responses to Cas proteins used in gene editing.
• Collaborate on projects combining cell biology, chemistry and bioinformatics.
• Work under a mentor and contribute to safety assessments for therapeutic proteins.

Connaissances

Immunology techniques

Bioinformatics

Computational biology

Molecular biology

Formation

Master's or PhD in Immunology / Biochemistry / Biology / Pharmaceutical Sciences / Bioinformatics / Computational Biology

Description du poste

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CBER-2026-0091

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.

FDA Office and Location

A research opportunity is available in the Division of Hemostasis (DH), Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) in Silver Spring, Maryland.

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

Learning Objectives

Under the guidance of a mentor, you will receive training in cutting edge technologies directly relevant to promoting public health, opportunities to attend seminars and formal training programs. You will participate in collaborative projects with academia and/or industry and will thus be well positioned for diverse career options after the training period.

Mentor

The mentor for this opportunity is Zuben Sauna ([e-mail]). 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.

Qualifications

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

Point of Contact

Richard

Eligibility Requirements

Degree: Master's Degree or Doctoral Degree received within the last 60 months or currently pursuing.

• Discipline(s):
  • Chemistry and Materials Sciences (
  • Analytical Chemistry
  • Bio-inorganic Chemistry
  • Bio-organic Chemistry
  • Biophysical Chemistry
  • Chemistry (General)
  • Environmental Chemistry
  • Inorganic Chemistry
  • Materials Sciences
  • Organic Chemistry
  • Physical Chemistry
  • Polymer Chemistry
  • Theoretical Chemistry
• Computer, Information, and Data Sciences (17 )
  • Life Health and Medical Sciences (48 )
    • Mathematics and Statistics (11 )

Affirmation

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.)