The FDA’s Office of Tissues and Advanced Therapies (OTAT), Division of Cellular and Gene Therapies (DCGT) is recruiting a senior scientist who will serve as Chief of Cell Therapies Branch to provide a programmatic supervision and direction on the scientific and regulatory review of the manufacture and control of complex cellular products intended for a therapeutic use in human.
DCGT is strongly committed to bringing FDA and other scientists, patient advocates, and the public together in partnership to develop new therapies for the 21st Century, while protecting human subjects and ensuring product safety. The candidate will be a part of a cutting-edge and fast-paced scientific and regulatory environment.
The incumbent of this position will:
• Serve as Branch Chief by providing overall directions to the branch staff for regulatory review of Investigational New Drug applications (IND), Biologic License Application (BLA), Investigational Device Exemption (IDE), Pre-Market Notification [510 (k)], Pre-Market Approval (PMA) applications, and their supplements/amendments associated with the development, manufacture, and clinical use of cellular therapy products, tissue engineered products, xenotransplantation product, and certain medical devices.
• Plan work to be accomplished by subordinates, sets and adjusts short-term priorities, and prepares schedules for completion of work.
• Serve as the product authority for regulatory review on chemistry, manufacturing and controls (CMC) for cellular therapies, including tissue engineered products and xenotransplantation products, and related medical devices.
• Make decisions for CMC regulatory documents pertinent to cellular therapies in conjunction with the Division Director.
U.S. Citizenship is required for federal employment; This position may require occasional travel; Selective service registration is required for males born after 12/31/1959; A security investigation and/or 1-year supervisory probationary period may be required; Only experience gained by the announcement closing date will be considered.
PhD is preferred but is not a requirement.
In order to qualify for Supervisory Interdisciplinary Scientist, 0401/0403, at GS-15, all applicants must meet the following basic educational requirement for the particular series of interest:
Biology, GS-0401: Degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. – OR – A combination of education and experience with courses as shown above equivalent to a major plus appropriate experience or additional education.
Microbiology, GS-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. – OR – A combination of education and experience with courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown above, plus appropriate experience or additional education.
In addition to meeting one of the basic educational requirements above, all applicants must meet the specialized experience requirement below:
In order to qualify for the position of Supervisory IDS, GS-0401/0403-15, you must have one year of specialized experience, equivalent to the GS-14 in the Federal service which includes providing programmatic direction and oversight on scientific and regulatory review and documentation of the manufacture and control of novel and complex cellular products which may include, but not limited to, somatic cell therapy, stem cell therapy, cellular immunotherapy, tissue engineering and regenerative medicine advanced therapy, and xenotransplantation products which the Branch is responsible for regulatory review and action.
LOCATION: This position is located in the Center for Biologics Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT), Division of Cellular and Gene Therapies (DCGT) located in Silver Spring, MD.