Senior Staff Fellow

Senior Staff Fellow (Research / Review Scientist – Cell and Gene Therapy / Immunology / Personalized Vaccines / Bioprocessing Engineering / Advanced Manufacturing)

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 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 Senior Staff Fellow (Research / Review Scientist – Cell and Gene Therapy / Immunology / Personalized Vaccines / Bioprocessing Engineering / Advanced Manufacturing) position in the DCGT.  The selected candidate will serve as Principal Investigator (PI) to lead an independent research laboratory in fields relevant to regulation of cell and gene therapy, including cellular immunotherapy, personalized cancer vaccines, immunology, gene therapy, bioprocessing engineering related to regenerative medicine and gene therapy product manufacturing. The selected individual will establish an independent research program that complements existing expertise in the DCGT and relates to the safety, efficacy or immunogenicity of cellular immunotherapy products including genetically-modified cells, cancer vaccines, and/or gene therapy vectors. Areas of potential interest could include (but are not limited to):

• Genetically-modified T cells or hematopoietic cells
• Gene therapy vectors, especially AAV
• Personalized cancer vaccines incorporating computational biology (MHC-peptide algorithms) and immunology of antigen processing and presentation.
• Bioprocessing and innovative manufacturing technologies for cell and gene therapy products.

The selected individual will also review regulatory applications and help to develop policy and guidance in cell and gene therapies. 

Please see http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/default.htm for information about regulatory oversight of cellular and gene therapies. Please see http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/BiologicsResearchAreas/ucm124376.htm for information about research programs and investigators in DCGT.

The FDA White Oak Campus has new state of the art laboratories with high-quality core facilities that include veterinary support and a vivarium, animal imaging, microscopy, flow cytometry, genomics, proteomics, and biotechnology.

This position will be filled through the Service Fellowship program.  Applications will be accepted from all groups of qualified persons, including U.S. citizens or non-U.S. citizens holding valid immigration status and work authorization at the FDA.  No 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:  Official transcripts required; Ph.D. in a biomedical or related science or equivalent doctoral degree (M.D., D.V.M., etc.) required.  (NOTE: Applicants must also demonstrate that they meet the minimum requirements for the occupational series for which they are being considered.)

Candidates must have a Ph.D. or equivalent degree (e.g., MD, DVM, or ScD) and at least two years of relevant postdoctoral laboratory experience. Successful candidates will have a record of outstanding research productivity, exceptional communication skills and clear evidence of leadership potential.  This position is subject to a background investigation.

SALARY:  Salary is commensurate with education and experience, with an excellent benefits package.

LOCATION: Silver Spring, MD

HOW TO APPLY:  Submit electronic resume or curriculum vitae with a cover letter containing a brief summary of scientific accomplishments and the names/contact information of three references to CBER Recruitment at CBER.Employment@fda.hhs.gov.  Applications and all supporting documentation will be accepted through July 31, 2018.  Please reference Job Code: OTAT-18-0010-TER.

NOTE:  Please be advised that this position may be subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for me, my spouse, and my minor children. I will be required to file a Confidential Financial Disclosure Report (OGE 450) and may be required to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made.  For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at http://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/default.htm.

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