*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.
The selected participant will join a research program that studies in vitro the mechanism and effect of codon optimization in antibodies, and recombinant proteins, specifically coagulation factors. Theparticipant will be part of an active group, join the lab meetings and learn from other lab members the assays and the analysis of the results.
Learning objectives for the participant:
- Possible mechanisms for codon optimization to affect structure and activity of proteins
- Understanding and testing the conformation of codon optimized vectors vs. wild type sequence using models of antibodies and coagulation factors’ products, and interpretation of the assay results.
- Method development and optimization of purification of proteins. This will involve in cell culture (mammalian cells), establish of stable cell lines that carry the inserted codon optimized genes, and learn and compare various ways to purify proteins.
The following examples of articles published since 2020 provide examples of the range of work performed in our group; note that a previous ORISE participant is part of several publications:
- Kames J., Holcomb D.D., Alexaki A., Santana-Quintero L., Athey J.C., Hamasaki-Katagiri N., Katneni U., Golikov A., Ibla J.C., Haim B., and Kimchi-Sarfaty C.: TissueCoCoPUTs: Novel Human Tissue-Specific Codon and Codon-Pair Usage Tables Based on Differential Tissue Gene Expression. JMB. 2020. https://doi.org/10.1093/oxfordjournals.molbev.a004201
- Kames J., Holcomb D.D., Kimchi O., DiCuccio M., Hamasaki-Katagiri N., Wang T., Komar A.A., Alexaki A., Kimchi-Sarfaty C.: Sequence analysis of SARS-CoV-2 genome reveals features important for vaccine design. Scientific Reports. https://doi.org/10.1038/s41598-020-72533-2.
- Katneni U.K., Holcomb, D.D., Hernandez N.E., Hamasaki-Katagiri N., Hunt, R.C., Bar H, Ibla J. and Kimchi-Sarfaty C. 2020. In silico features of ADAMTS13 contributing to plasmatic ADAMTS13 levels in neonates with congenital heart disease. Thrombosis Res. 193:66-76, 2020.
- Katneni K., Alexaki A., Hunt R., Schiller T., DiCuccio M., Buehler P.W., Ibla J.C., and Kimchi-Sarfaty C.: Consumptive Coagulopathy and Thrombosis during Severe COVID-19 Infection: Potential Involvement of VWF/ADAMTS13. https://doi.org/10.1055/s-0040-1715841. Thrombosis and Hemostasis 2020.
- Holcomb D., Alexaki A., Hernandez N., Laurie K., Kames J., Hamasaki-Katagiri N., Komar A.A., DiCuccio M., and Kimchi-Sarfaty C.: Potential impact on coagulopathy of gene variants of coagulation related proteins that interact with SARS-CoV-2. PLOS Computational Biology 17(3): e1008805. 2021
- Holcomb D., Hamasaki-Katagiri N., Laurie Kyle, Katneni U., Hernandez N., Kames J., Alexaki A., Bar H. and Kimchi-Sarfaty C.: New approaches to predict the effect of co-occurring variants on protein characteristics. Submitted. 2021
Anticipated Appointment Start Date: September 2021
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.
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 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.