FDA Internship on Analytical Method Development for Complex Drug Analysis

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 27,000 - 40,000; Full time

Job summary

Oak Ridge Institute for Science and Education (ORISE) offers a research opportunity in FDA's CDER-OPQR, located in Silver Spring, MD. The project focuses on developing validated NMR, DLS, and FPLC methods to assess biologic drug products and complex generics, under the guidance of a mentor.

Eligible candidates are pursuing or have completed a bachelor’s, master’s, or doctoral degree by 6/30/2027. The appointment lasts one year with potential renewal, and includes a monthly stipend commensurate

Qualifications

• Degree(s) in Chemistry or related field required or anticipated by 6/30/2027.
• Fields include Chemistry, Analytical Chemistry, Biophysical Chemistry, Organic/Inorganic/Physical Chemistry.
• Background check required for onboarding.

Responsibilities

• Participate in research on NMR, dynamic light scattering, and FPLC analysis.
• Assist in development and validation of analytical methods for biologic drugs.
• Learn under a FDA mentor and contribute to regulatory science.

Education

Bachelor's Degree

Master's Degree

Doctoral Degree

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDER-2026-0182

Application Deadline

1/31/2027 3:00:00 PM Eastern Time Zone

Description

• *Applications are reviewed on a rolling-basis and applications may close before the deadline.

FDA Office and Location

A research opportunity is available in the Office of Pharmaceutical Quality Research (OPQR), Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), located in Silver Spring, Maryland.

Research Project

The pharmaceutical analysis conducted in CDER labs includes in-depth analysis of complex and biologic drug products. Research activities require extensive experimental research to generate the data and results important to advance regulatory science and to support drug product quality research. The project will aim to develop validated NMR, DLS and FPLC methods to assess the identity, purity, content and higher-order structure of biologic protein drugs and complex generic drugs of novel oligonucleotide. The resulting analytical data will support product-specific guidance development, regulatory review, and scientific evaluation of complex generic and biosimilar drug products, thereby strengthening the FDA's regulatory science.

Learning Objectives

Under the guidance of the mentor, the participant will learn about high field NMR, dynamic light scattering, fast protein liquid chromatography, and complex data analysis.

Mentor

The mentor for this opportunity is Kang Chen ([e-mail]). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date

2027. 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 Administration

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.

Background Investigation

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 be currently pursuing or have received a bachelor's, master's, or doctoral degree in one of the relevant fields to be received by 6/30/2027.

• Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 months or anticipated to be received by 6/30/2027 12:00:00 AM.
• Discipline(s):
  • Chemistry and Materials Sciences
  • Analytical Chemistry
  • Bio-inorganic Chemistry
  • Bio-organic Chemistry
  • Biophysical Chemistry
  • Chemistry (General)
  • Environmental Chemistry
  • Inorganic Chemistry
  • Materials Sciences
  • Organic Chemistry
  • Physical Chemistry
  • Polymer Chemistry
• Engineering (5 )
  • Life Health and Medical Sciences (4 )

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