*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This opportunity is available for a highly motivated candidate who will receive training on a BSL-2 Surface-Plasmon Resonance (SPR) (Biacore) based method to measure SARS-CoV-2 neutralizing antibodies in human convalescent plasma and Immune Globulins. The participant will conduct research with a team to develop and to compare the SPR-based assay against in vitro neutralization assays. The participant will join a research group that is experienced in the use of SPR for evaluation of plasma samples, and is experienced in virologic techniques and structure/function studies of viral binding to receptors.
The participant will join a research program that studies methods to detect neutralizing antibody activity in serum or plasma against viruses, and the effect of neutralizing antibodies in commercially produced Immune Globulin therapies in animal models. The current work of the laboratory is focused upon development of a BSL-2 method to reliably measure neutralizing antibody activity against SARS-CoV-2 in convalescent plasma, to provide a safe and fast method for selection of high-titer donations for COVID-19 therapy. The research team has already developed and tested a similar assay for H1N1 influenza antibodies.
Learning objectives for the participant:
- Theory and techniques of Surface Plasmon Resonance methods for binding/binding inhibition detection and characterization; mathematical methods for determining binding characteristics, and protein interaction kinetics
- Methods for measuring antibody-mediated viral neutralization for SARS-CoV-2, such as pseudo type virus assays and SARS-CoV-2 virus-based assays (the ORISE Fellow will not be required to work directly with live SARS-CoV-2 virus)
- Optimization of SPR-based methods, including experimental conditions, sample treatment, and reagent requirements
- Methods to ascertain structural characteristics of SARS-CoV-2 binding to its receptors
- Strategies for development of reference standards, how international standards are developed, and how to test candidate reference SARS-CoV-2 antibody reagents
The participant will conduct research in close association with experimental biologists in developing and optimizing the SPR neutralization assay for convalescent human serum/plasma, and animal serum (from animals immunized against SARS-CoV-2).
Anticipated Appointment Start Date: August 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 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. 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 (FDA-CBER-2021-0038) in your email.