FDA Fellowship – Cell Membrane Microparticles and Nanoparticles

Overview

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is currently available in the Office of Blood Research and Review (OBRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

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: The first research project you will be involved with is focused on cellular and molecular aspects of new methods of long-term storage of blood platelets for transfusion. Platelets for transfusion can only be stored for 5 to 7 days. Platelet cryopreservation would improve platelet availability in remote locations and military operations and building a platelet inventory for refractory patients. The state-of-the-art platelet cryopreservation method uses 6% dimethylsulfoxide (DMSO) as a cryoprotectant. Platelets, however, undergo major damage during DMSO-cryopreservation, including membrane transition and release of different populations of platelet membrane extracellular vesicles (EVs). Content and activities of platelet EVs in DMSO cryopreserved platelets (CPP) and other platelet products may significantly impact their safety and efficacy. This project establishes characterization criteria for EVs, as important components of cryopreserved platelets and EV-based hemostatic biologics. Currently, the impact of specific EV populations on product safety and efficacy remains unknown. By identifying clinically important particle populations and defining characterization criteria, this addresses unmet clinical needs and ensures patient safety and efficacy.

The second research project you will join is focused on characterization of protein and lipid particles in blood transfusion products, such as freeze-dried plasma, and plasma derivatives, particularly in intravenous immunoglobulin (IVIG) products. The presence of subvisible protein particles in IGIV products has been implicated to play a significant role in IVIG-associated adverse events. We have initiated a collaborative project to investigate IGIV protein particle characteristics in relation to their vascular toxicity effects.

Learning Objectives: You will gain theoretical knowledge in platelet biology and platelet transfusion science, including current methods of platelet processing and storage and needs for long term platelet storage. You will gain theoretical knowledge and practical experience in laboratory assays for evaluation of quality of platelets for transfusion, characterization of platelet membrane vesicles, and other membrane changes in platelets stored for transfusion and new methods of platelet cryopreservation. You will gain theoretical knowledge and practical experience in laboratory methods for analysis and characterization of subvisible protein and lipid particles and evaluation their biological activities in tissue culture models.

Mentor: The mentor for this opportunity is Jan Simak (jan.simak@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: June 27, 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 and Lawful Permanent Residents (LPR) only.

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.
Qualifications
Applicants should have received a doctoral degree in one of the relevant fields (Life Sciences, Biology, Chemistry, Physics or related sciences).

Preferred skills:

Excellent communication skills.
A strong drive for lab research and some background in life sciences.
Training will be provided in all techniques but individuals with laboratory experience in biomedical research, skills in cell biology, hematology, cryobiology, or protein chemistry will be preferred.