FDA Research Opportunity in Therapeutic Proteins

Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CBER-2021-0003
How to Apply

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A complete application consists of:      

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.

Application Deadline
1/11/2021 3:00:00 PM Eastern Time Zone
Description

*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.

Under the guidance of a mentor, the selected participant will join a research program that broadly studies the characteristics and immune responses to therapeutic proteins that carry non-synonymous and synonymous mutations. The participant will collaborate with experimental biologists to purify these proteins and then test them for conformation (using limited proteolytic digestion, Circular Dichroism (CD)), immunogenicity risk (by MAPPS assay or T-cell proliferation assay) and functionality.

The following articles in the literature provide examples of the range of research performed in our group:

Katneni, U.K., Liss, A., Holcomb, D., Katagiri, N., Hunt, R.C., Bar, H., Ismail, A., Komar, A.A. and Kimchi-Sarfaty, C.: Splicing dysregulation contributes to the pathogenicity of several F9 exonic point variants. Molecular Genetics & Genomic Medicine E-published; 2019; 00:e840, DOI: 10.1002/mgg3.840). 2019.

Hettiarachchi G.K., Katneni U.K., Hunt R.C., Athey J.C., Kames J.M., Bar H., Sauna Z.E., McGill J.R., Ibla J.C. and Kimchi-Sarfaty C.: Translational and transcriptional responses in human primary hepatocytes under hypoxia. American Journal of Physiology - Gastrointestinal and Liver Physiology, doi: 10.1152/ajpgi.00331.2018.

Katneni U.K., Ibla J.C., Hunt R.C., Schiller T. and Kimchi-Sarfaty C.: Von Willebrand Factor/ADAMTS13 Interactions at Birth: Implications for Thrombosis in the Neonatal Period. Journal of Thrombosis and Haemostasis 17(3):429-440, 2019.

Alexaki A., Kames J., Holcomb D.D., Athey J., Santana-Quintero L.V., Lam P.V.N., Hamasaki-Katagiri N.,
Osipova E., Simonyan V., Bar H., Komar A.A., and Kimchi-Sarfaty C.: Codon and Codon-Pair Usage Tables (CoCoPUTs): Facilitating Genetic Variation Analyses and Recombinant Gene Design. Journal of Molecular Biology. https://doi.org/10.1016/j.jmb.2019.04.021. 2019.

Alexaki A., Hettiarachchi G.K., Athey J., Katneni U.K., Simhadri V., Hamasaki-Katagiri N., Nanavaty P., Lin B., Takeda K., Freedberg D., Monroe D., McGill J.R., Peters R., Kames J., Holcomb D.D., Hunt R.C., Gelinas A., Janjic N., DiCuccio M., Bar H., Komar A.A., and Kimchi-Sarfaty C.: Effects of codon optimization on protein translation and structure: Implications for protein therapeutics. 2019. Scientific Reports, in press.

Anticipated Appointment Start Date: Winter 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.
Qualifications

The qualified candidate should be currently pursuing or have received a bachelor's, master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.

Preferred skills:

  • Experience in the purification and characterization of proteins in mammalian systems
  • Basic genetic engineering and molecular biology skills
  • Experience in both experimental methods in protein chemistry and data analysis
  • Experience in basic lab work, such as sterile tissue culture techniques, purification, Western blotting
  • Willingness to learn new technologies and methods, such as ribosome profiling
  • Willingness to learn new in silico technologies and methods
Eligibility Requirements
  • Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 months or currently pursuing.
  • Discipline(s):
    • Computer, Information, and Data Sciences (1 )
    • Life Health and Medical Sciences (46 )