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This position is located in the Center for Biologics Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT), ivision of Cellular and Gene Therapies (DCGT), Gene Therapies Branch (GTB) located in Silver Spring, MD.
As a Biologist/Microbiologist, you will have the following responsibilities:
- Review and evaluate Investigational New Drugs Applications (INDs), Investigational device Exemption (IDE), Premarket application (PMAs), 510(k), Biologics License Applications (BLAs), amendments and supplemental applications.
- Prepare written evaluations, presenting and documenting the results of these reviews.
- Prepare a comprehensive summary of the data reviewed and submit substantive recommendations and conclusions to the Branch Chief.
- Coordinate the review of IND and BLA submission and supplements by the division.
Requirements: U.S. Citizenship is required for federal employment; This position may require occasional travel; Selective service registration is required for males born after 12/31/2959; A security investigation and/or 1-year probationary period may be required; Only experience gained by the announcement closing date (March 7, 2018) will be considered.
PhD is preferred but is not a requirement.
In order to qualify for Biologist/Microbiologist, 0401/0403, at GS - 13, you must meet the following:
ALL APPLICANTS MUST MEET ONE OF THE FOLLOWING BASIC EDUCATION REQUIREMENTS:
Basic Education Requirements for Biologists: Degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. - AND/OR - Have a combination of education and experience: Courses equivalent to a major, as shown in above, plus appropriate experience or additional education.
Basic Education Requirements for Microbiologists: 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. - AND/OR - Have a combination of education and experience: courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in the above, plus appropriate experience or additional education.
IN ADDITION TO MEETING THE BASIC EDUCATION REQUIREMENT, ALL APPLICANTS MUST ALSO MEET THE SPECIALIZED EXPERIENCE REQUIREMENT:
In order to qualify for the position of Interdisciplinary Scientist GS-13, you must have one year of specialized experience, equivalent to the GS-12 in the Federal service to include extensive basic or translational research experience in virology, microbiology, gene therapy, genome editing, molecular biology, immunology, or a related field. You must have strong collaborative skills, excellent written and oral communication skills, and evidence of leadership potential.
Please review the official job opportunity announcement on USAJobs.gov for additional requirements and application procedures. Applications must be received by applying to the official job opportunity announcement. Please pay careful attention to the Qualifications and Required Documents sections of the announcement.