Undergraduate Internships – CDER
A complete application consists of:
- 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
- Two educational or professional references
All documents must be in English or include an official English translation.
If you have questions, send an email to FDArpp@orau.org. Please include the reference code for this opportunity in your email.
This program is an opportunity in which participants engage with a mentor or mentors in the Office of Pharmaceutical Quality during a targeted internship to examine a question of interest to the office.
The interns will focus on research projects related to the quality of approved drug products available in the marketplace. As technology advances, the development and evaluation of advanced analytical techniques is necessary to ensure drug product quality. While drug manufacturers may perform a variety of advanced analytical tests in-house, the release of this more complex data is not always submitted to the FDA for review. Through a thorough evaluation of different analytical methodologies for the analysis of drug product quality (including small molecule drugs, protein therapeutics, peptides, carbohydrates, etc.), the amount and type of information that can or cannot be obtained by different approaches can be evaluated, which may include but not limited to spectroscopy, mass spectrometry, ion mobility and liquid chromatography, allowing for future suggestions and guidance development to ensure the highest quality of FDA-approved drugs.
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. These appointments are part-time (20 hrs) or full-time with an initial appointment ranging from 2 to 12 months, but may be renewed upon the recommendation of FDA and contingent on the availability of funding. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is at the FDA in either St. Louis, Missouri, or the SIlver Spring, Maryland area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.
These opportunities are available to currently enrolled students or recent graduates (within five years).
A strong background in written and oral communication with demonstrated excellence in science-related courses or research opportunities is preferred.
US citizenship, green card, Employment Authorization document (EAD), Optional Practical Training (OPT), or Curricular Practical Training (CPT) is required. The participant does not become an FDA employee and there are no fringe benefits paid.
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