OFFICE OF THERAPEUTIC PRODUCTS (OTP)
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
FOOD AND DRUG ADMINISTRATION (FDA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

The Office of Gene Therapy (OGT) and Office of Cellular Therapy and Human Tissue (OCTHT) within the Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) at FDA are recruiting to fill multiple Staff Fellow positions to serve as a researcher-reviewer in the Gene Transfer and Immunogenicity Branch (GTIB), the Tumor Vaccines and Biotechnology Branch (TVBB), and the Cellular and Tissue Therapy Branch (CTTB) within OGT and OCTHT.

OGT and OCTHT protect and enhance public health by assuring that cell and gene-based therapeutic products (including cancer vaccines) and tissue engineered products are safe and effective.

RESPONSIBILITIES: The successful candidate will perform the following major duties:

• Conducting laboratory research related to cell therapy or gene therapy, including developing novel strategies to assess safety of these products and research on characterizing and manufacturing these products. The successful candidate will join one of the research labs in OGT and OCTHT based on the candidate’s qualifications and area of research. Currently, OGT and OCTHT labs perform research in the following areas:
  • Gene therapy
  • Genome editing
  • AAV vectors
  • Immunology
  • Hematopoietic stem cells
  • CAR-T cells
  • CAR-NK cells
  • Next-generation sequencing
  • Cell therapy (adult cells and stem cells)
  • Cell-based tissue engineered products
  • Biomaterials
• Performing 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.

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.

PREFERRED SPECIALIZED EXPERIENCE: For positions in OGT labs, candidates with prior research experience in immunology, virology, gene therapy, or genome editing are desirable. For positions in OCTHT labs, experience in biomaterials and/or bioreactors, cell manufacturing, and -omics analysis (metabolomics and proteomics), immunology, cell therapy, or next-generation sequencing is desirable. To learn more about current research programs, please visit the Tissue & Advanced Therapies Research | FDA.

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 for undergraduate and graduate degrees 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.

HOW TO APPLY: Submit electronic resume or curriculum vitae, a cover letter in which you describe your qualifications and career goals and name and contact information for two references (non-government employees) to Rebecca.Escobar@fda.hhs.gov. Applications and all supporting documentation will be accepted through April 30, 2024 and will be reviewed on a rolling basis. Please reference Job Code: OTP-24-02-CJP.

ADDITIONAL INFORMATION: For additional information on CBER Careers, please visit:

• Jobs at the Center for Biologics Evaluation and Research (CBER) | FDA
• Scientific Careers at the FDA

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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