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.CFSAN@orau.org. Please include the reference code for this opportunity in your email.

*Applications will be reviewed on a rolling-basis.

Four research opportunities are available at the U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Regulatory Science (ORS) located in College Park, Maryland.

The FDA is actively developing new molecular species identification tools to stand alone, and to complement established chemical methods. To help with this, the FDA has been expanding a publicly available chloroplast sequence database which includes a skim (or snapshot) of the mitochondrial, chloroplast and nuclear genomes. These data have given the FDA the ability to characterize complex plant-based materials in traceback and complaint investigations using a genome skimming method utilizing high throughput sequencing. The selected participants will be involved in method validation that leverages the database and an established next generation sequencing protocol. The goal of this research is to fully describe and quantify what plants are present in dietary supplements and botanical raw materials—including adulterants, toxic species, allergenic species—by targeting DNA in a validated genome skimming (whole genome shotgun). This method could be utilized by FDA as well as external stakeholders (e.g. academics, industry analysts, and testing laboratories). Under the guidance of a mentor, the participants will be involved in the following research activities:

• Generate chloroplast genome sequence data for plants deemed to be of FDA interest. Sequencing will be carried out, using the Illumina Miseq as well as other next generation sequencing platforms. Vouchered and taxonomically-identified source materials will be obtained from in-house and external collections and collaborators
• Determine which plant materials should be included in blended botanical samples for testing with input from FDA’s Center for Drug Evaluation and Research. Participate in the development of blended botanical samples. This will include a trip to the New York Botanic Garden in New York City to collaborate with Damon Little.
• Contribute to the design of and carry out a validation of a genome skimming method for use in analyzing food and dietary supplements
• Collaborate with researchers at the CFSAN-Office of Applied Research and Safety Assessment in the use of an FDA designed public pipeline for analyzing generated sequences from food/dietary supplements that have been analyzed using genome skims

Anticipated Appointment Start Date: May 1, 2020

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 in the College Park, 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.

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.

Preferred skills:

• Experience performing DNA extractions, library preparations and next generation sequencing 
• Experience with method validation, botanical samples and bioinformatically analyzing large data sets
• Ability to effectively communicate both verbally and in writing

• Citizenship: LPR or U.S. Citizen
• Degree: Master's Degree or Doctoral Degree received within the last 60 months or currently pursuing.
• Discipline(s):
  • Environmental and Marine Sciences (6 )
  • Life Health and Medical Sciences (8 )