Description

A research opportunity is available immediately with the Food and Drug Administration (FDA), The National Center for Toxicological Research (NCTR) located in Jefferson, Arkansas. The National Center for Toxicological Research (NCTR), is the only FDA Center located outside the Washington D.C. metropolitan area. The one-million square foot research campus in Jefferson, Arkansas plays an important role in the missions of FDA and the Department of Health and Human Services to promote and protect public health. Research Project: This fellowship will focus on investigating the metabolism of nitrosamine drug substance-related impurities (NDSRIs) and its potential impact on mutagenicity and carcinogenicity to address critical FDA regulatory knowledge gaps regarding drug safety. You will collaborate with an interdisciplinary team of scientists to elucidate metabolic activation pathways of structurally complex NDSRIs, with a particular emphasis on DNA adduct formation, using in vitro metabolic systems and mammalian cell models. These studies will provide mechanistic insights into the structure-activity relationships underlying the mutagenic and carcinogenic potency of NDSRIs. The research activities will also support improvements in (quantitative) structure-activity relationship ([Q]SAR) modeling and enhance the FDAs ability to conduct regulatory safety assessments of NDSRIs in affected drug products. Under the guidance of the mentor, you will receive hands-on training in mechanistic study design, experimental execution, and systematic evaluation in the fields of drug metabolism and chemical carcinogenesis. Educational activities will include: Gaining experience with in vitro metabolism studies using liver S9 fractions, microsomes, and mammalian cell culture systems. Learning to characterize major intermediates and metabolites using high-performance liquid chromatography-ultraviolet spectroscopy (HPLC-UV), liquid chromatography-tandem mass spectrometry (LC-MS/MS), and/or proton nuclear magnetic resonance spectroscopy (1H-NMR). Developing skills in the identification and quantification of DNA adducts formed by NDSRIs in S9/microsomal incubations with DNA and in cell culture systems, using 1H-NMR and LC-MS/MS. Presenting research findings at scientific conferences and publishing results in peer-reviewed journals. You will gain valuable research experience and scientific insight to support career advancement in toxicology, drug development, and regulatory affairs across multiple sectors. Anticipated Appointment Start Date: October/November 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.

Requirements

The qualified candidate should be currently pursuing or have received a 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 12/31/2026. Degree: Doctoral Degree received within the last 60 months or anticipated to be received by 12/31/2026 11:59:00 PM. Discipline(s): Chemistry and Materials Sciences Life Health and Medical Sciences Please see the link below for additional details and application information: https://www.zintellect.com/Opportunity/Details/FDA-NCTR-2026-0004