Staff Fellow – Researcher-Reviewer

Staff Fellow – Researcher-Reviewer   

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 Cellular Therapy and Human Tissue (OCTHT) within the Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) at FDA is recruiting Staff Fellows to serve as researcher-reviewers in the Tumor Vaccines and Biotechnology Branch (TVBB) and the Cellular and Tissue Therapy Branch (CTTB) within OCTHT.

OCTHT protects and enhances public health by assuring 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 OCTHT based on the candidate’s qualifications and area of research. Currently, OCTHT labs perform research in the following areas:
• Microphysiological systems
• Cell therapy (adult cells and stem cells)
• Cell-based tissue engineered products
• Biomaterials
• Gene therapy
• CAR-T cells
• CAR-NK cells

• 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: Experience in biomaterials, microphysiological systems, cell manufacturing, immunology, cell therapy, machine learning and artificial intelligence, lipid nanoparticle (LNP) delivery, tissue-specific drug delivery, protein engineering, T cell receptor-engineered T cell (TCR-T) or tumor-infiltrating lymphocyte (TIL) therapy is desirable. To learn more about current research programs, please visit the Tissue & Advanced Therapies Research nearmejobs.eu 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 required.
• Background and/or Security investigation required.
• If applicant is an U.S. Citizen, males born on, or after, December 31, 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.
• 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 Federal Resume*  with a cover letter in which you describe your qualifications and career goals to [email protected].  Applications and all supporting documentation will be accepted through November 31, 2024 and will be reviewed on a rolling basis. Please reference Job Code: OTP-24-09–FDA

*For more information on what to include in your Federal Resume, please click on the following USAjobs.gov link: https://www.usajobs.gov/help/faq/application/documents/resume/what-to-include/

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

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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES IS AN EQUAL OPPORTUNITY EMPLOYER WITH A SMOKE FREE ENVIRONMENT