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    Opportunity: Principal Investigator: Molecular Biologist with Bioinformatics experience @ U.S. FDA's Center for Biologics Evaluation and Research (CBER) -- Silver Spring, MD (US)
    Submitted by Nicole Nieves; posted on Friday, July 14, 2023

    OFFICE OF BLOOD RESEARCH AND REVIEW (OBRR)
    CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
    FOOD AND DRUG ADMINISTRATION (FDA)
    DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

    Become a part of an agency that touches the lives of every American!

    The FDA's Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR), Division of Emerging and Transfusion Transmitted Diseases (DETTD) is recruiting to fill a Senior Staff Fellow/Visiting Scientist position to serve as a Principal Investigator in the Laboratory of Emerging Pathogens (LEP).

    BACKGROUND

    DETTD employees are actively engaged in research on projects related to detection, immunology and pathogenesis of infectious agents that can be transmitted by blood transfusion. DETTD is located at the FDA's White Oak campus in Silver Spring, Maryland and is part of the CBER research program, which includes more than 70 principal investigators. These investigators lead research teams in the fields of virology, parasitic infections, bacteriology, and gene therapy employing state-of-the-art techniques to address critical public health issues as part of the CBER mission. In addition to BSL-3, ABSL-3 and animal care facilities, the newly built laboratory complex at White Oak includes core facilities, such as flow cytometry and confocal and electron microscopy. Scientist in LEP are actively engaged in research to develop novel molecular tools and bioinformatics for the detection and monitoring of transfusion transmitted pathogens including parasitic, bacterial, and viral pathogens and the application of molecular techniques to identifying host biomarkers of pathogenesis.

    RESPONSIBILITIES

    • The PI will initiate a research program on pathogenesis of blood-borne infections using bioinformatics knowledge to help develop biomarkers for early detection and to further enhance safety of blood and blood components.
    • The incumbent will also review submissions and serves on committees related to regulatory review and policy development in OBRR.
    • The incumbent will develop in-house analytical expertise useful to the Office on high-throughput biomedical data generated by microarray, next-generation sequencing, transcriptomics, proteomics, and metabolomics platforms. In addition, the selected candidate will participate in the regulatory review of submissions for vitro diagnostic devices for testing blood donations and patient diagnosis/monitoring of infection.
    • The candidate will also participate in development of policy to ensure the safety of the nation's blood supply from transmission of infectious agents.

    BASIC QUALIFICATIONS

    Applicants will be required to meet the specific qualification requirements of the applicable occupational series below.

    General Natural Resources Management and Biological Sciences (RG-0401): Degree in Biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position, – OR – Combination of education and experience in courses equivalent to a major, plus appropriate experience or additional education.

    OR

    Microbiology (RG-0403): Degree in microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent.

    ADDITIONAL QUALIFICATIONS

    A Ph.D. in Biomedical Sciences or equivalent doctoral degree (M.D., D.V.M., or Sc.D. etc.) is required. Candidates must have demonstrated productivity as evidenced by publication record in the area of molecular microbiology with application of bioinformatics to solve biological questions relevant to microbial pathogenesis.

    PREFERRED SPECIALIZED EXPERIENCE

    Candidates must have post-doctoral experience in molecular biology focusing on the pathogenesis of infectious agents with demonstrated experience in using various bioinformatics platforms and analyses tools. Previous experience in regulatory review is desirable but not a requirement. The candidate must have demonstrated oral and written communication skills and potential for leadership, mentoring and managing professional and technical staff.

    FOREIGN EDUCATION

    If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

    SALARY

    Salary is commensurate with education and experience and includes an excellent benefits package.

    LOCATION

    FDA White Oak Campus in Silver Spring, MD

    CONDITIONS OF EMPLOYMENT

    This position will be filled through the Service Fellowship program, with an initial appointment period followed by opportunities for renewal. Applications will be accepted from all groups of qualified candidates, including U.S. citizens or non-U.S. Citizens holding valid immigration status and work authorization at the FDA. No previous Federal experience is required. Appointment does not confer any entitlement to a position in the competitive service, and during the initial appointment there is no entitlement to Merit Systems Protection Board (MSPB) appeals rights.
    • One-year probationary period may be required.
    • Official Transcripts required.
    • Background and/or Security investigation required.
    • If applicant is an U.S. Citizen, males born on, or after, December 31st, 1959, must be registered with the Selective Service System or have an approved exemption. Visit the Selective Service System for more info.
    • Prohibited financial interest restrictions may apply. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office webpage.
    • Non-US and permanent residents are required to have resided in the United States for a minimum of three of the last five years.

    HOW TO APPLY

    Please submit your Federal Resume* and a cover letter containing a brief summary of scientific accomplishments to CBER.Employment[at]fda.hhs.gov and Tanesha.Washington[at]fda.hhs.gov. Full applications with all supporting documents (i.e., transcripts, names/contact information for three references, proof of U.S. citizenship or lawful permanent residency status, and other supporting documentations) should be submitted by September 11, 2023. Applications will be reviewed on a rolling basis. Please reference Job Code: OBRR-23-16-BIF.

    *For more information on what to include in your Federal Resume, please click on the following USAjobs.gov link: https://www.usajobs.gov/help/faq/application/documents/resume/what-to-include/

    ADDITIONAL INFORMATION

    For additional information on CBER Careers, please visit: HHS/FDA is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    DEPARTMENT OF HEALTH AND HUMAN SERVICES IS AN EQUAL OPPORTUNITY EMPLOYER WITH A SMOKE FREE ENVIRONMENT

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