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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.CBER@orau.org. Please include the reference code for this opportunity in your email.
Applications will be reviewed on a rolling-basis, and this opportunity will remain open until filled.
A research opportunity is currently available in the Office of Vaccine Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The laboratory is investigating the immunobiological mechanisms responsible for the suboptimal vaccine responses in newborns and infants. The goal of these studies is to improve the efficacies of pediatric vaccines using adjuvants targeting the pathways responsible for the blunted immune responses. This project is using neonatal mice from immunocompetent as well as various transgenic backgrounds to study the immune responses to diverse vaccine platforms including mRNA vaccines (SARS-CoV-2) and novel delivery systems. The analysis of immune response involves detailed investigation of the cellular and molecular mechanisms controlling the development of follicular helper T (Tfh) cells and germinal center B cells. The candidate will participate in experimental design, immunization and analyzing cellular and molecular responses to vaccines in addition to writing manuscripts and presenting her/his research in national and international meetings.
The ORISE Research Participation Program at the U.S. Food and Drug Administration is an educational and training program designed to provide college students, recent graduates, and university faculty opportunities to connect with the unique resources of the FDA. With the support of an assigned mentor, participants have authentic hands-on research experience and allows them access to unique research opportunities, top scientists and engineers, and state-of the art facilities and equipment. The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services. CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
Anticipated Appointment Start Date: 2024.
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 one year, 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. 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.
The qualified candidate should have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within the past five years.
Preferred skills:
- Excellent command of multi-color flow cytometry and standard immunology techniques
- Experience with RNA-seq, bioinformatics and single cells sequencing
- Previous mouse handling experience
- Ability to collaborate with others in a team environment
- Strong written and verbal communication skills
- Publication record in peer-reviewed journals
- Degree: Master's Degree or Doctoral Degree received within the last 60 month(s).
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Discipline(s):
- Life Health and Medical Sciences (13 )
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.)
I have read the FDA Ethics Requirements.
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The ORISE GO mobile app helps you stay engaged, connected and informed during your ORISE experience – from application, to offer, through your appointment and even as an ORISE alum!