Research Project Description
In Vitro/In Vivo Biological Drug Assessment Fellowship
Office of Clinical Pharmacology
Division of Applied Regulatory Science
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD
A fellowship opportunity is currently available in the Office of Translation Sciences (OTS) within the Office of Clinical Pharmacology (OCP) in the Division of Applied Regulatory Sciences at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).
This project focuses on developing methods to support the safety and efficacy review of innovator and biosimilar drugs at CDER. Testing will utilize in vitro methods and in vivo humanized mouse models. The selected participant will be involved in the testing of biological drug products that are of regulatory significance to CDER and may be involved in several of the following aspects of the project:
- Experimental design, testing and assessment of biologics in humanized mice
- Isolation of stem cells from human tissues
- Surgery to humanize severely immune-compromised mice
- Multi-parameter flow cytometry
- Assays, including ELISA, ELISpot, nucleofection (Amaxa), and PCR
- Literature review and manuscript preparation
The Research Participation Program for FDA is administered by the Oak Ridge Institute for Science and Education (ORISE). 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 depending on educational level and experience. The participant must show proof of health insurance. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.
- A Doctoral degree in immunology or a related discipline received within the last five years.
- Proficiency in multi-color flow cytometry and experience with standard immunologic techniques, including aseptic tissue processing and cell culture, is required.
- Previous mouse handling experience is essential; experience with immune-compromised mouse strains is preferred.
- Publication record in immunology in peer-reviewed journals is desired.
- U.S. citizenship or Lawful Permanent Resident status is required.
How to Apply:
To be considered, please send a current CV/resume to the attention of FDArpp@orau.org. Please reference FDA-CDER-2014-0011 in all communication.