To submit your application, scroll to the bottom of this opportunity and click 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

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.

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*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), located at Silver Spring, Maryland.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

Research Project: This project focuses on evaluating a lung microphysiological system (MPS) to measure the concentration of anti-infective drugs in the epithelial lining fluid (ELF). Specifically, the aim is to assess the concordance between drug concentration profiles obtained from MPS experiments and clinical data. The study will also identify any limitations or discrepancies in the MPS model's performance compared to clinical observations. Ultimately, this project seeks to evaluate the potential of the lung MPS to provide supportive evidence or serve as an alternative to ELF clinical studies.

Learning Objectives: Under the guidance of a mentor, the participant will gain hands-on experience with MPS technology, in vitro drug testing, and advanced analytical methods to quantify drug concentrations in the ELF, contributing to improved drug development for respiratory infections. Additionally, the participant will be trained to compare experimental results with clinical data to assess the predictive capabilities of the MPS model. This experience will enhance the participant's understanding of pharmacokinetics and the application of in vitro models in drug development.

Anticipated Appointment Start Date: 2024/2025.  Start date is flexible and will depend on a variety of factors.

Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation: The appointment is full time.

Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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 Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists. 

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 be currently pursuing or have received a doctoral degree in the one of the relevant fields (e.g. biomedical engineering, pharmaceutical sciences, chemical engineering, or a closely related field). Degree must have been received within the past five years, or anticipated to be received by 6/30/2025.

Preferred skills:

• The qualified candidate has a strong background in micro physiological systems, organ-on-a-chip technologies, or related in vitro models, as well as experience in mammalian cell culture, and in vitro drug testing. 
• Experience in designing and conducting experiments, particularly in the culture of human primary cells and bioanalytic, is highly desirable.

• Degree: Doctoral Degree received within the last 60 months or anticipated to be received by 6/30/2025 12:00:00 AM.
• Discipline(s):
  • Engineering (2 )
  • Life Health and Medical Sciences (2 )

I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
and
I have read the FDA Ethics Requirements.