FDA CBER OCTHT Summer Research Internship

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A complete application consists of:

• An application
• 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.CBER@orau.org. Please include the reference code for this opportunity in your email.

A summer research opportunity is available in the Office of Cellular Therapy and Human Tissues (OCTHT), in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) in Silver Spring, MD.

CBER’s mission is to ensure the safety, purity, potency, and effectiveness of biological products including vaccines, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury. The selected participant will have the opportunity to learn how biomedical engineering tools would be used in the assessment of regenerative medicine advanced therapeutic products such as cellular and tissue engineered products. The project will employ a variety of approaches including Microfluidics, Biomaterials engineering, Cell-materials imaging, and Molecular biology.

The candidate will perform research developing methods of labeling neural stem cells with Magnetic Resonance Imaging (MRI) contrast reagents. The goal of the research is to improve our ability to track cell and migration survival post transplantation by MRI in models of cellular therapy products. The candidate can expect to learn how to culture cells, gain exposure to many basic laboratory techniques, and learn how to document scientific experiments.

Anticipated Appointment Start Date: June 1st, 2023 (start date is flexible). This appointment is expected to last for 2.5 months.

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. 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.

Applicants must be U.S. citizens or long-term permanent resident (LPR) and at least 18 years of age at the time of the appointment. Applicants must be a student in good standing at an accredited U.S. college or university, or accepted as an entering graduate or professional student at an accredited college or university, with a cumulative GPA of 3.25 or higher (based on a 4.0 scale).

Candidates with classwork related to Biomedical Sciences and an interest in pursuing a career in Biomedical Sciences are desirable.

• Citizenship: LPR or U.S. Citizen
• Degree: Currently pursuing an Associate's Degree, Bachelor's Degree, Master's Degree, or Doctoral Degree.
• Overall GPA: 3.25
• Discipline(s):
  • Engineering
  • Life Health and Medical Sciences
  • Other Physical Sciences

I certify that I will be at least 18 years of age. I am a student in good standing at an accredited U.S. college or university, or I have been accepted as an entering graduate or professional student at an accredited college or university, with a cumulative GPA of 3.25 or higher (based on a 4.0 scale).