FDA Postdoc Fellowship- PBBM/PBPK Model Library for Development of Predictive Dissolution Methods for Medium and High Risk Solid Oral Immediate Release Products

Research Project

In order to develop predictive dissolution methods for medium and high risk solid immediate release (IR) drug products, PBBM/PBPK modeling is a powerful tool. This project aims to develop a PBBM/PBPK model libraries for the most commonly prescribed medium and high risk drug products that the assessors can readily use in their assessment of the dissolution methods.

Learning Objectives

• Learn data mining
• Conduct literature search
• Develop PBBMs/PBPK in modeling and simulations software (e.g., GastroPlus, Simcyp etc.)
• Gain experience in applying Biopharmaceutics principles in product development as well as regulatory assessment

Mentor

The mentor for this opportunity is Bhagwant Rege (bhagwant.rege@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date

July 1, 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.

Program Information

The 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.

Background Investigation

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.

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Qualification Requirements

The qualified candidate should have received or be currently pursuing a doctoral degree in one of the relevant fields.

Preferred Skills/Knowledge

• Strong analytical capability
• Pharmacy / pharmacology related knowledge is preferred

Application Process

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

Required Documents

• 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

Document Submission

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

Contact Information

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