FDA Fellowship in 3D Printing of Drug Products
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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.
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Pharmaceutical Quality (OPQ) / Office of Testing and Research (OTR) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), located in Silver Spring, Maryland. As an emerging technology, the incorporation of active ingredients within personalized 3D printed products has not been fully evaluated for consistency of product performance. The project will identify the critical quality attributes (CQAs) of 3D printed drug products using various 3D printing technologies.
Under the guidance of a mentor, the participant will acquire deep understanding in the application of 3D printing technologies. The participant will be exposed to the development processes of drug product manufacturing involving risk assessment, identifying design spaces and developing novel characterization tools.
Anticipated Start Date: The start date is flexible and will depend upon a variety of factors.
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 initial appointment is for two months, but may be renewed upon recommendation of FDA contingent on the availability of funds. 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 full-time at FDA in the Silver Spring, Maryland, area. 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 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.
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 research covers more than just medicines.
The qualified candidate should have received or be currently pursuing a doctoral degree in pharmaceutical sciences, 3D printing, and/or Pharmacology. Qualified master's may also be considered provided that the candidate demonstrates strong analytical knowledge of 3D printing of drug products.
A strong background and hands-on of 3D printing technologies, pharmaceutical manufacturing, and characterization of pharmaceutical drug products are preferred.
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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