*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available in the Office of Blood Research and Reviews (OBRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The first research project 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 vesicles. Content and activities of platelet membrane vesicles in DMSO cryopreserved platelets (CPP) may significantly impact safety and efficacy of CPP. The proposed project is focused on development and optimization a panel of assays for characterization and in vitro potency for quality control of CPP products. In addition, the project will investigate cryoprotective effects of various novel cryoprotectants including engineered nanomaterials for platelet cryopreservation. The participant 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. The participant 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.
The second research project the participant will be involved 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 (IGIV) products. The presence of subvisible protein particles in IGIV products has been implicated to play a significant role in IGIV-associated adverse events. We have initiated a collaborative project to investigate IGIV protein particle characteristics in relation to their vascular toxicity effects. The participant 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.
Anticipated Appointment Start Date: November 2021; 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 eight months, 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. 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.
If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity in your email.