Evaluation of Placental Drug Transfer Using an In Vitro Human Placental Barrier Model - FDA CBER

- Silver Spring, MD4.0

Full-timeEstimated: $67,000 - $91,000 a year
Organization U.S. Food and Drug Administration (FDA)
Reference Code FDA-CBER-2019-0015
How to Apply

A complete application consists of:
An application
Transcripts – Click here for detailed information about acceptable transcripts
A current resume/CV, including academic history, employment history, relevant experiences, and publication list
One educational or professional recommendation. Your application will be considered incomplete, and will not be reviewed until one recommendation is submitted.
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 8/30/2019 3:00:00 PM Eastern Time Zone
A research opportunity is available in the Division of Cellular and Gene Therapies (DCGT), 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.

During pregnancy, the placenta is responsible for the support and nourishment of the developing fetus, and is also a physiological barrier preventing the transfer of select biological factors and larger molecular sized chemicals. Prescription medications are of great concern during pregnancy because the drug metabolites may be able to cross the placenta, causing fetal defects. Under the guidance of a mentor, the participant will receive training on how to develop a reliable, high-throughput screening platform to evaluate drug transport from maternal blood across the placenta barrier to fetal blood. Using the platform, the participant will also receive training on how experimental models can be used to investigate how and when drug metabolites transfer across the placental barrier in pregnant women. Training in this area will provide the participant with regards to how the newly developed assays could be employed in the assessment of various products regulated at the FDA.

  • Although the application deadline is August 30th, applications will be reviewed on a rolling-basis.
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, MD, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

The Homeland Security Presidential Directive-12 (HSPD-12) mandates a background check be completed for both U.S. Citizens and foreign nationals. Foreign nationals must have resided in the U.S. for at least three (3) of the past five (5) years in order for FDA to be able to complete a background check.

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.
The qualified candidate should have received a doctoral degree in one of the relevant fields, or be currently pursuing the degree and will reach completion by the application deadline. Degree must have been received within five years of the appointment start date.

Preferred skills/experience:
3D in vitro system
Cell and molecular biology
Eligibility Requirements
Degree: Doctoral Degree received within the last 60 months or anticipated to be received by 8/30/2019 12:00:00 AM.

Engineering (4 )
Life Health and Medical Sciences (1 )