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FDA Fellowship Investigating the Impact of Formulation and Manufacturing Factors on the Injectable Sustained-Release Drug Products

Oak Ridge Institute for Science and Education · Silver Spring, MD · 1 wk ago
OTHRFull-time

About the role

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by ensuring 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.

Research Project

This project involves research that supports the development of product-specific guidance and recommendations that can guide generic product development of opioid products. The research also includes investigating issues related to the manufacturing process of in-situ forming extended-release dose forms.

Learning Objectives

  • Participate in a project focused on the evaluation of opioid abuse-deterrent formulations under the guidance of a mentor.
  • Conduct pharmaceutical evaluation including in vitro and in vivo studies to assess the effect of lipid excipients on the physicochemical properties of the drug product.
  • Receive training and guidance from project mentors and staff scientists in problem solving and study design.
  • Learn about the purpose and strategy of conducting scientific research at FDA.
  • Gain hands-on experience with advanced characterization techniques.
  • Learn how regulatory assessment is performed and how the agency promotes public health by ensuring effective and safe drug products are available to the public.

Qualifications

  • Applicants should be currently pursuing or have received a doctoral degree in one of the relevant fields.

Education

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of their start date, setting forth the conditions and expectations for their educational appointment at the agency. This agreement covers topics such as:

  • 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.

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 valid immigration statuses acceptable for program participation.

Appointment Terms

  • Appointment length: Initially one year, renewable upon recommendation of FDA and contingent on the availability of funds.
  • Level of participation: Full time.
  • Stipend: Monthly stipend commensurate with educational level and experience.
  • Proof of health insurance is required for participation.
  • 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 onboarding at FDA.
  • OPM can complete a background investigation only for individuals, including non-U.S. citizens, who have resided in the U.S. for a total of three of the past five years.

FDA Ethics Requirements

If an ORISE Fellow, including their spouse and minor children, reports a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO (except for spousal employment with an SRO), and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

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