FDA Postdoctoral Fellowship: Cell and Gene Therapy

*Applications will be reviewed on a rolling-basis, and this opportunity will remain open until filled. FDA Office and Location: A research opportunity is currently available at the Center for Biologics Evaluation and Research (CBER), in the Office of Therapeutic Products(OTP), at the Food and Drug Administration (FDA) in Silver Spring, Maryland. Research Project: 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. The successful candidate will perform laboratory research on projects related to cell and gene therapy. The candidate will use advanced manufacturing tools and strategies to gain a deeper understanding of challenges associated with T cell-based immunotherapies such as CAR-T cells and develop novel strategies to improve safety and efficacy of T cell therapies. Learning Objectives: The overall project goals for the participant are as follows: Will perform laboratory research on projects related to cell and gene therapy. Will use advanced manufacturing tools and strategies to gain a deeper understanding of challenges associated with T cell-based immunotherapies (such as CAR-T cells). Develop novel strategies to improve safety and efficacy of T cell therapies. Anticipated Start Date: Start date is flexible 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. 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. 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 doctorate in one of the relevant fields (Life Health and Medical Sciences) or currently pursuing with an expected graduation date before May 31, 2024. Degree must have been received within the past five years. Preferred skills: The ideal candidate will have direct experience with: Cell and Gene Therapy Advanced manufacturing tools T-cell based immunotherapies CAR-T cells

The application must be completed through Zintellect. https://www.zintellect.com/Opportunity/Details/FDA-CBER-2024-0016