FDA Research Opportunity for Developing Bioassays Using Ovarian Cancer Cells

Overview

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A Postdoctoral Fellow opportunity is available with Dr. Wen Jin Wu and located at Division of Pharmaceutical Quality Research III (DPQR III), Office of Pharmaceutical Quality Research (OPQR), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER) in Silver Spring, Maryland.  Funding for this opportunity will be provided by the Office of Commissioner (OC), Office of Women’s Health (OWH).

Research Project: Under the guidance of the mentor, the participant will study trispecific antibodies using woman breast and ovarian cancers and animal as models to improve FDA-regulated product quality, safety, and anti-tumor activity and to facilitate drug development to treat women’s cancers

Learning Objectives:

Develop an understanding of antibody therapeutic concepts, including the principles of bispecific and trispecific antibodies
Learn how to design different molecular formats for bispecific and trispecific antibodies using genetic engineering approaches, applying appropriate structural and functional considerations
Learn how to carry out experiments for the expression and production of bispecific and trispecific antibodies using established laboratory methods
Gain experience in performing comprehensive characterization studies of bispecific and trispecific antibodies including:Physiochemical analysis
Biological activity assessment
Mechanism of action investigations
Bioassay development
Apply acquired knowledge to support ongoing research projects and regulatory mission, and advance their professional development in antibody therapeutics
Mentor: The mentor for this opportunity is Dr. Wen Jin Wu (wen.wu@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: 2026.  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.

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 Ph.D.  or equivalent degree with an educational background in molecular and cell biology, pharmacology and drug discovery/development, or be currently pursuing. Degree must have been received within the past five years or be currently pursuing.

Lab skills in common molecular and cell biology techniques are preferred.