FDA Postdoctoral Fellowship - Investigating the Effects of Cell-Materials Interactions on the Safety and Effectiveness of Cell Therapy Products
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
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity in your email.
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is available in the Cellular and Tissue Therapy Branch (CTTB), Office of Therapeutic Products (OTP), Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) in Silver Spring, Maryland
This is part of a collaborative research program with the Massachusetts Institute of Technology (MIT), providing a unique opportunity to collaborate closely with investigators at both institutions. As a selected fellow, you will conduct research at FDA and MIT facilities and participate in interdisciplinary projects at the interface of regulatory science and biomedical engineering.
The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services. CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
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 project will explore methods and approaches to improve the manufacture of small extracellular vesicles (sEV), formerly known as exosomes, based therapeutics. Under the guidance and direction of investigators, the applicant will apply engineering, cell culture, and microbiology techniques to investigate the biogenesis, production, and purification of sEV from cell culture in bioreactors. The overall objective is to increase the knowledge and understanding of the parameters that impact the quantity and quality of sEV production.
Learning Objectives: Through this fellowship, you will have the opportunity to learn about production of sEV, an emerging and cutting-edge biological product with the potential to address gaps in drug delivery and treatment.
Mentor: The mentor for this opportunity is Kyung Sung (kyung.sung@fda.hhs.gov) If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: No later than September 30, 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, 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 a Ph.D. in a related field such as biochemical or chemical engineering, biological sciences, or related field. Degree must have been received within five years of the appointment start date.
Preferred skills:
- Experience with the growth of mammalian cells, ideally MSCs or HEK293 cells;
- Experience with the production, measurement, and characterization of sEVs (nanoparticle tracking, immunoblotting for sEVs markers, and TEM);
- Experience analyzing cell culture medium components using HPLC and ELISA or similar methods;
- Ability to prioritize multiple activities, troubleshoot technical issues, develop and execute detailed technical protocols, and act independently and as part of a team;
- Excellent documentation and oral and written communication skills;
- Experience with bioreactor set-up, operation, and maintenance.
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.)
and
I have read the FDA Ethics Requirements.
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