FDA Fellowship in Immunogenicity of Therapeutic Proteins
*Applications will be reviewed on a rolling-basis, and this posting will remain open until filled.
A research opportunity is available in the Division of Plasma Protein Therapeutics (DPPT), Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) in Silver Spring, MD.
This opportunity is available for a highly motivated candidate who will assist on a project to study the immune responses of proteins used as therapeutics. Suitably qualified candidates will have obtained a Master's or doctorate degree within the last five years. The candidate will join a research group that uses both experimental and computational approaches to understand immune responses to therapeutic proteins. It is essential that the candidate have experience in flow cytometry. This opportunity offers training in cutting edge technologies directly relevant to drug development, opportunities to attend seminars and formal training programs. The candidate will serve on collaborative projects with academia and/or industry and will thus be well positioned for diverse career options after the training period.
The successful candidate will join a research program that broadly studies the immune responses to therapeutic proteins (immunogenicity). Proteins are used in therapeutic applications in many ways. Monoclonal antibodies for disease targets, replacement proteins and as components of gene therapy and gene editing. The successful candidate will join experimental biologists, computational biologists, immunologists and clinicians to identify genetic risk factors for immunogenicity. They will design and execute assays to determine which T cell subpopulations are activated by the the model protein therapies we use (principally coagulation Factors VIII and VIIa and Cas proteins). They will also study the effect of mode of delivery of the therapeutic on the immune response.
The following articles in the literature provide examples of the range of research performed in our group:
Nat. Commun. 12: 5090, 2021
Front. Med. 8: 663396, 2021
Trends Mol. Med. 27: 1074, 2021
Front. Immunol. 10: 2894, 2019
Blood Adv. 3: 2668-2678, 2019
AAPS J. 21: 96, 2019
Blood Adv. 3: 1429-1440, 2019
Mol Ther Methods Clin Dev. 10: 105-112, 2018
Sci. Transl. Med. 9: eaag1286, 2017
Blood 125: 223-228, 2015
Nature Med. 19: 1318-1324, 2013
PLoS Comput. Biol., 9, e1003066, 2013
Nature Biotechnol. 29: 870-873, 2011
This opportunity offers training in cutting edge technologies directly relevant to drug development, opportunities to attend seminars and formal training programs. The candidate will serve on collaborative projects with academia and/or industry and will thus be well positioned for diverse career options after the training period.
Additional information about the appointment:
A supplemental allowance of up to $500 per month, in addition to the regular monthly stipend, to allow the candidate to purchase health insurance is available.
An allowance for training and/or scientific conference attendance may also be available, contingent upon available funding and DHHS, FDA, CDC, and local and/or state public health alerts related to the COVID-19 pandemic.
Anticipated Appointment Start Date: September 1, 2022 (start date is flexible)
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 initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. An allowance for health insurance will be provided. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. 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 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 disciplines, or be currently pursuing one of the degrees with completion by September 1, 2022. Degree must have been received within five years of the appointment start date.
- Experience in advanced techniques in immunology
- Experience with flow cytometry is highly desirable
- Familiarity with basic techniques and principles in cell and molecular biology and biochemistry would be desirable
- Willing to learn new technologies and methods and operate outside their comfort zone will be strongly preferred