Division of Applied Regulatory Science
U.S. Food and Drug Administration
Silver Spring, MD
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences, Division of Applied Regulatory Science (DARS) is recruiting post-doctoral fellows for biologics research using cutting edge humanized mouse models. DARS conducts a wide array of research to address regulatory science questions that include safety and efficacy of drugs. For more detail on the research activities of the division, please refer to Translating New Science Into the Drug Review Process: The US FDA's Division of Applied Regulatory Science .
Biologics Postdoctoral Fellow(s): Biologics fellows will work on projects related to a variety of biological drug product questions including 1) factors affecting biosimilarity, 2) causes of immunogenicity, 3) biomarkers development and 4) immuno-oncology product adverse events. Approaches will include in vitro, in vivo and ex vivo studies.
Drug-induce Liver Injury (DILI) Postdoctoral Fellow. The DILI post-doctoral fellow will investigate mechanisms of injury to the liver that may be immune-mediated using novel animal models. A strong background in mechanisms of hepatic injury and experience with liver function is essential.
Professional Skills and Experience:
- A Doctoral degree in immunology, toxicology or a related discipline, received within the last three years.
- Proficiency in multi-color flow cytometry.
- Experience with standard immunologic techniques including aseptic tissue processing, cell culture, ELISA, and cell-based assays is required.
- Previous mouse handling experience is required; experience with immune-compromised mouse strains is preferred. Animal surgical skills are desirable.
- Excellent communication and interpersonal skills are required as this candidate will be expected to work productively in a collaborative, cross-functional team environment.
- Strong attention to detail with the ability to analyze, interpret and present study data coupled with an aptitude for learning.
- Excellent written and verbal communication skills.
U.S. CITIZENSHIP OR U.S. PERMANENT RESIDENT STATUS IS REQUIRED.
Key Tasks and Responsibilities:
- Responsible for design, execution, and interpretation of drug testing using in vitro, in vivo and ex vivo methods and techniques
- Isolation and culture of cells from human tissues and mice
- Surgery to humanize severely immune-compromised mice
- Multi-parameter flow cytometry
- Assays including ELISA, ELISpot, and PCR
- Literature review and manuscript preparation
How to apply: send CV and letter of interest to DARSrecruitment@fda.hhs.gov.
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 and may be renewed upon recommendation of FDA and contingent on the availability of funds. The participant will receive a monthly stipend depending on educational level and experience. The appointment is full-time at FDA in the Silver Spring, MD area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.
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