FDA Office and Location: A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), Office of Pharmaceutical Quality (OPQ), located at St. Louis, Missouri.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
Research Project: Some over-the-counter (OTC) drug products contain multiple active pharmaceutical ingredients (API) and require several analytical methods to assess drug product quality. Recalls of multi-component OTC products have occurred due to undeclared levels of APIs, API sub-potency, and presence of impurities. Poor quality OTC products on the market have the potential to cause consumers’ harm. To address this quality concern, FDA will conduct research utilizing various analytical techniques to evaluate OTC products and identify opportunities to develop improved methods for their quality evaluation.
Learning Objectives: Under the guidance of the mentor, the participant will gain experience with preparing samples and evaluating the quality of multi-component OTC products using a variety of analytical techniques, such as high-performance liquid chromatography (HPLC) and dissolution to assess product quality attributes such as potency, impurity, content uniformity, and drug release information. The participant may develop sample preparation procedures using an automatic sample preparation system in conjunction with evaluating opportunities for developing multi-analyte HPLC methods to facilitate product quality evaluations. The participant will learn the skills relevant for the project including laboratory basics for pharmaceutical analysis and scientific software for data analysis. As the project progresses, the participant will gain experience in developing a scientific process, drawing conclusions from their findings, and communicating their results through various channels such as technical reports, meeting presentations, and manuscripts. Overall, the learning objectives aim to equip the participant with skills and knowledge necessary to pursue a career in pharmaceutical research, development, and regulation.
Anticipated Appointment Start Date: 2025. 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.
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.