Center for Biologics Evaluation and Research (CBER), USFDA

Staff Fellow – Cell and Gene Therapy Reviewer

Center for Biologics Evaluation and Research (CBER), USFDA

Silver Spring, MD, United States

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)

Become a part of an agency that touches the lives of every American!

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies’ (OTAT), Division of Cellular and Gene Therapies (DCGT), Cell Therapies Branch (CTB) and Gene Therapies Branch (GTB) are recruiting full-time review scientists.

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.

If you specialize in Cell Therapy, Cell and Stem Cell Biology, Microbiology, Cellular Immunology, Cancer Biology, Biomedical Engineering, Virology, Biochemistry, Molecular Biology and/or Gene Therapy we are looking for you.

What Does CBER Have to Offer You?

CBER is committed to facilitating the development of new biological products, to include but not limited to cell and gene therapies, plasma protein therapeutics, and select medical devices for a broad range of complex and often times life-threatening diseases as well as rare diseases. By joining CBER, you will fuel your own passions and use your many talents, skills, and experiences to help CBER successfully navigate the challenges and opportunities of 21st Century medicine.

RESPONSIBILITIES: As a Cell and Gene Therapy Reviewer, the selected candidate will have the opportunity to:

  • Perform scientific review, interpretation, and documentation of product manufacturing data to evaluate the safety and quality of cell therapy products (e.g., stem cells, cancer vaccines, cellular immunotherapies, engineered tissue, medical devices) or gene therapy products (e.g., genetically modified cells, viral or nonviral vectors, genome editing, and peptide/neoantigen- and gene-based cancer vaccines) in regulatory submissions to FDA.
  • Contribute to guidance and policy development activities relevant to cell and gene therapy.

BASIC QUALIFICATIONS: Ph.D. or equivalent advanced degree with a strong research background in cell therapy, cell and stem cell biology, cellular immunology, cancer biology, regenerative medicine, biomedical engineering, microbiology, virology, biochemistry, molecular biology and/or gene therapy. Occupational series which may be considered include General Natural Resources Management and Biological Sciences (RG-0401), Microbiology (RG-0403), and Biomedical Engineering (RG-0858). Please refer to the link for each occupational series for more information regarding specific education requirements. 

ADDITIONAL QUALIFICATIONS: Candidates are expected to be proficient in applying relevant scientific knowledge and research experience to support multi-disciplinary scientific and review of regulatory submissions. In addition, the candidate must have strong collaborative skills, excellent written and oral communication skills, and evidence of leadership potential.

PREFERRED SPECIALIZED EXPERIENCE: Postdoctoral experience is highly preferred. Also, knowledge of federal regulations applicable to drugs, biologics, and medical devices is helpful but not a requirement for consideration.

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. For more information on the Service Fellowship program, please visit the FDA’s Service Fellowship Program webpage.

  • 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: Please submit a statement of interest, resume, or curriculum vitae (CV) detailing relevant experience, transcripts, names/contact information for three references, proof of U.S. citizenship or lawful permanent residency status, and other supporting documentations to William Lewis at william.lewis@fda.hhs.gov . Applications will be accepted through February 6, 2022. However, candidates will be considered as received. For best consideration, please submit your application as soon as possible. Please reference Job Code: OTAT-22-08-NAT.

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.

Apply with CV and Cover Letter

Must be a .doc, .docx, or .pdf file and no larger than 1MBMust be a .doc, .docx, or .pdf file and no larger than 1MB
Position

Staff Fellow – Cell and Gene Therapy Reviewer