FDA Internship on Analytical Method Development for Complex Drug Analysis
To submit your application, scroll to the bottom of this opportunity and click APPLY.
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
- 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 ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.
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**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.
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 effort covers more than just medicines.
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 (kang.chen@fda.hhs.gov). 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.
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.
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.
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.
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.)
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