FDA-CDER Fellowship in the Intranasal Administration of Monoclonal Antibodies and other Biological Therapeutics

*Applications will be reviewed on a rolling-basis. A start date in early March 2024 is preferred. 

CDER Office/Lab and Location: A research opportunity is available in the Office of Biotechnology Products (OBP), Office of Pharmaceutical Quality (OPQ) within the 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 FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This research covers more than just medicines.

Research Project: The goal of this research is to establish and characterize a bioassay for the transcytosis of monoclonal antibodies across polarized epithelium. Immortalized cell lines will be characterized and compared to primary epithelial cells using immunohistochemistry, RNA analysis, and protein quantification to identify cell lines that best model natural tissues. The established cell line(s) and culture strategies will be used to evaluate the permeation kinetics of a panel of monoclonal antibody constructs and related biological therapeutics under both sterile conditions and during respiratory viral infections.  

Under the guidance of the mentor, the participant will learn general research techniques such as critical thinking, experimental design and aseptic technique and gain specialized skills including cell culture, immunohistochemistry, real-time PCR, and western blotting. Additionally, the participant will have opportunities to strengthen their written and oral communication skills. Depending on the demonstrated proficiency of the research participant and the duration of the appointment, individuals will have the opportunity to gain virological research skills under biosafety level 2 conditions. 

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 appointment is for 12 months. 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 Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as 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. 

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.

Qualifications

The qualified candidate should have received a Bachelor's or Master's degree in biology, microbiology, or related disciplines. Degree must have been received within five years of the appointment start date.