The Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Cellular and Gene Therapies (DCGT) is recruiting to fill a Staff Fellow position in the Gene Transfer and Immunogenicity Branch. OTAT/DCGT protects and enhances public health by assuring that gene and cell-based therapeutic products (including stem cell products) and tissue engineered products are safe and effective.
The successful candidate will perform FDA/OTAT mission relevant laboratory research on assessing immunogenicity of gene therapy products, and developing novel strategies to reduce host immune response against these products. In addition, the candidate will spend approximately 50% of time performing regulatory review of gene and cell therapy product applications submitted to the FDA.
This position will be filled through FDA's Staff Fellowship program. The appointment is for up to four years with opportunities for renewal. Applications will be accepted from all groups of qualified persons, including non-citizens. No previous Federal experience is required. Appointment does not confer any entitlement to a position in the competitive service, and there is no entitlement to Merit Systems Protection Board (MSPB) appeals rights.
QUALIFICATIONS: The successful candidate will have a Ph.D. or an equivalent degree (e.g., M.D., DVM, or Sc.D.), in biomedical science, and post-doctoral experience in virology and/or immunology is preferred. Expertise in T cell immunology and viral vectors is highly desirable. Candidate must have strong collaborative skills, and excellent written and oral communication skills. Official transcripts are required. Applicants must demonstrate that they meet the basic requirement for the desired occupational series below.
Biology, RG-0401: Degree in Biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position, -OR- Combination of education and experience: Courses equivalent to a major, plus appropriate experience or additional education.
Microbiology, RG-0403: Degree in Microbiology; or biology, chemistry, or basic medical science that include at least 20 semester hours in protein chemistry, immunology and microbiology, and 20 semester hours in physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent. -OR- Combination of education and experience--courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that include course as shown above, plus appropriate experience or additional education.
SALARY: Salary commensurate with education/experience.