FDA Fellowship - Inactive Ingredient (IID) Program operated by OB

Oak Ridge Institute for Science and Education; White Oak (MD); On-site; USD 42,000 - 54,000; Full time

Job summary

Oak Ridge Institute for Science and Education invites applications for a full-time research opportunity with the FDA, CDER, at White Oak, Maryland. The role focuses on the IID program, supporting queue management, data validation, and IT analytics while gaining exposure to regulatory processes.

The appointment features a one-year initial term with potential renewal, eligible for U.S. citizens or LPRs, and a monthly stipend commensurate with education and experience.

Qualifications

• Master's or doctoral degree in chemistry, pharmacology, data science, or a related field earned within the last five years.
• Strong data management and spreadsheet skills.
• Eligibility: U.S. citizen or LPR; background investigation required.

Responsibilities

• Assist with queue management and communications.
• Review and validate data for the IID program, including MDE values.
• Support IT initiatives and analytics within the IID program.
• Collaborate with stakeholders across regulatory processes.

Skills

Knowledge in biology

Excel proficiency

Communication skills

Education

Master's degree or Doctoral degree in relevant field

Tools

Microsoft Excel

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDER-2026-0152

Application Deadline

11/20/2026 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 immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in White Oak, Maryland.

Research Project

The Inactive Ingredients Database (IID) program within the FDA's Center for Drug Evaluation and Research (CDER) serves as an important resource for identifying inactive ingredients (excipients) present in FDA-approved drug products, supporting both drug development and regulatory processes. This opportunity will provide you with hands-on exposure to the operational and administrative infrastructure that sustains and advances the IID program. Appointment activities may include: assisting with queue management, supporting communications, participating in reviewing and validating the maximum daily exposure (MDE) values for inactive ingredient (excipients) that lead to quarterly IID updates, contributing to IT initiatives and analysis activities; and engaging with improvement efforts related to the IID program's operational infrastructure.

Learning Objectives

Through this appointment, you will gain skills and experience with FDA's regulatory processes and the role of inactive ingredient in drug development, data management, and IT analysis, deepening understanding of how regulatory databases are developed, maintained, and leveraged for strategic decision-making. You will also have the opportunity to strengthen your professional skills in communication, and collaborative teamwork in a multidisciplinary regulatory context.

Mentor

Diana Solana-Sodeinde ([e-mail])

Anticipated Appointment Start Date

November 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 and Lawful Permanent Residents (LPR) only.

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.

Qualifications

The qualified candidate should have received a master's or doctoral degree in one of the relevant fields (clinical pharmacology, pharmaceutical sciences, pharmacometrics, pharmacy, toxicology, biotechnology, biopharmaceutics, data science, computer science, or other medical or healthcare related field). Degree must have been received within the past five years.

Preferred Skills

• Knowledge in biology, physiology, pharmacy and pharmacology; computer database skills, and data management skills.
• Proficiency in Microsoft Excel and will be for reviewing, validating, and maintaining complex spreadsheets to ensure data accuracy, integrity, and consistency across organizational workflows.
• Ability to effectively communicate with different stakeholders.

Eligibility Requirements

• Citizenship: LPR or U.S. Citizen
• Degree: Master's Degree or Doctoral Degree received within the last 60 month(s).
• Discipline(s):
  • Chemistry and Materials Sciences
  • Chemistry (General)
  • Computer, Information, and Data Sciences (17)
  • Life Health and Medical Sciences (10)
  • Mathematics and Statistics (1)

Affirmation

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.)

Point of Contact

Ashley