FDA Fellowship Investigating Impact of Formulation and Manufacturing Factors Injectable Sustained-Release Job Silver Spring area,Maryland

Position: FDA Fellowship Investigating the Impact of Formulation and Manufacturing Factors on the Injectable Sustained-Release

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDER-

Final date to receive applications

10/23/2026 3:00:00 PM Eastern Time Zone

Description

Applications will be reviewed on a rolling-basis.

FDA Office and

Location:

A research opportunity is available with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in 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. These efforts cover more than just medicines.

Research

Project:

This project involves research that supports the development of product specific guidance and recommendations that can guide generic product development of opioid product. The research also includes investigating issues that are related to the manufacturing process of in-situ forming extended-release dose form.

Learning Objectives:

Under the guidance of a mentor, you will take part in a project focused on the evaluation of opioid abuse deterrent formulations. You will have the opportunity to be involved in pharmaceutical evaluation that includes in vitro and in vivo studies to assess the effect of lipid excipient to the physicochemical property of the drug product. In each area, you will be trained and guided by the project mentor and other staff scientists while being encouraged to participate in problem solving and study design as each facet of the project advances.

You will learn about the purpose and strategy of conducting scientific research will gain hands‑on experience on a variety of advanced characterization techniques. You will also learn how regulatory assessment is being performed and how the agency promotes the public health by ensuring effective and safe drug product is available to the public.

Mentor:

Bin Qin (Bin.Qin.gov).

Anticipated Appointment

Start Date:

2026. 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.

Participant Stipend:

The participant will receive a monthly stipend commensurate with educational level and experience.

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 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…