FDA Development of Analytical Methods to Assess Nitrosamine Impurities in Over-the-Counter (OTC[...]

Oak Ridge Institute for Science and Education; St. Louis (MO); On-site; USD 17,000 - 23,000; Full time

Benefits offered by this job

Monthly stipend based on education and experience

Job summary

A research organization based in St. Louis, Missouri, is seeking candidates for a position to develop and validate methods for analyzing nitrosamine impurities in drug products. Preferred candidates should have a master’s or doctoral degree in a relevant field, ideally with experience in analytical chemistry, particularly using LC or LC-MS techniques. This is a full-time opportunity, with a flexible start date and a stipend based on educational level and experience.

Qualifications

• Currently pursuing or received a master's or doctoral degree within the last five years.
• Strong background in analytical chemistry is required.
• Familiarity with LC and LC-MS techniques is preferred.

Responsibilities

• Develop and validate analytical procedures for drug product analysis.
• Screen for nitrosamine impurities in various drug products.
• Apply advanced analytical techniques mainly LC‑MS.

Skills

General laboratory skills and techniques

Analytical chemistry background

Experience with LC or LC-MS analysis

Education

Master’s or Doctoral degree in relevant fields

Tools

LC

LC-MS

Job description

How To Apply

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

• 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 [e-mail]. Please include the reference code for this opportunity in your email.

Reference Code

FDA-CDER-2026-0076

Application Deadline

6/12/2026 3:00:00 PM Eastern Time Zone

Description

Applications will be reviewed on a rolling-basis.

FDA Office and Location

The Center for Drug Evaluation and Research (CDER), located at St. Louis, Missouri.

Research Project

This project is located in the Office of Pharmaceutical Quality Research (OPQR), Office of Pharmaceutical Quality (OPQ). The project is to develop liquid chromatography-mass spectrometry (LC‑MS) methods for the analysis of nitrosamine impurities in drug products and apply the developed and validated methods to screen for these impurities in various drug products.

Learning Objectives

• Development and validation of analytical procedures to assess the qualities of pharmaceutical product.
• Application of advanced analytical techniques mainly LC‑MS in pharmaceutical analysis.
• Regulations pertaining to nitrosamine and other pharmaceutical impurities.
• Regulations of Over‑The‑Counter (OTC) drug products.

Mentor

The mentors for this opportunity are Jingyue (Jan) Yang ([e-mail]) and Tim Marzan ([e-mail]). If you have questions about the nature of the research, please contact the mentors.

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.

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.

Education

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.

Qualifications

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields. Degree must have been received within the past five years, or anticipated to be received by 9/30/2026.

Preferred Skills

• Proficiency in general laboratory skills and techniques, strong background in analytical chemistry, and experience with LC or LC‑MS analysis.

Point of Contact

Ashley

Eligibility Requirements

• Degree: Master’s Degree or Doctoral Degree received within the last 60 months or anticipated to be received by 9/30/2026 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
    • Theoretical Chemistry
  • Engineering
  • Environmental and Marine Sciences
  • Life Health and Medical Sciences
• 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.)
• I have read the FDA Ethics Requirements.