OFFICE OF TISSUES AND ADVANCED THERAPIES (OTAT)
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
FOOD AND DRUG ADMINISTRATION (FDA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
The FDA’s 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 two Staff Fellow positions to serve as a Biologist/Microbiologist in the Gene Transfer and Immunogenicity Branch (GTIB) or the Tumor Vaccines and Biotechnology Branch (TVBB).
OTAT/DCGT protects and enhances public health by assuring that cell and gene-based therapeutic products (including therapeutic vaccines) and tissue engineered products are safe and effective.
RESPONSIBILITIES: The successful candidate will perform the following major duties:
- Conducting relevant laboratory research on improving characterization of cell and gene therapy products and novel strategies of assessing tissue safety, function, and availability.
- Participating in the regulatory review of cell and gene therapy product applications submitted to the FDA.
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.
Microbiology (RG-0403): Degree in Microbiology; or biology, chemistry, or basic medical science that include at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, 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 included courses as shown in A above, plus appropriate experience or additional education.
ADDITIONAL QUALIFICATIONS: Ph.D. in Biomedical Science or equivalent doctoral degree (M.D., D.V.M., or Sc.D., etc.) is required. Candidates must also have strong collaborative skills, and excellent written and oral communication skills.
REQUIRED SPECIALIZED EXPERIENCE: For the position in GTIB, candidates must have postdoctoral experience in immunology, and expertise in viral immunology is highly desirable. For the position in TVBB, candidates must have postdoctoral experience in cellular biology. Expertise in clinical microbiology, tissue function and safety, and high-throughput technologies such as next-generation sequencing is highly desirable.
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, including 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 www.SSS.gov 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 website at FDA Ethics and Integrity Office.
- This position is subject to Executive Order 14043, mandating covid-19 vaccination for federal employees.
- 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: Submit electronic resume or curriculum vitae with a cover letter in which you describe your qualifications and career goals to CBER Recruitment at CBER.Employment@fda.hhs.gov. Applications and all supporting documentation will be accepted through December 15, 2021. Please reference Job Code: OTAT-22-03-CJP.
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