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Tuesday, March 16, 2010


FDA Regulatory Review Position - Adeno-Associated Virus (AAV) and Other Viral Vector Based Gene Therapy Products Expertise

The FDA’s Center for Biologics Evaluation and Research, Office of Cellular, Tissue, and Gene Therapies is recruiting an Interdisciplinary Scientist in the dynamic, highly challenging, and innovative atmosphere of Gene Therapy product review in the Gene Therapy Branch of the Division of Cellular and Gene Therapies (DCGT). In particular, the incumbent will review submissions related to Adeno-associated virus (AAV) based gene therapy products, other viral vectors, and related products. DCGT staff also reviews studies and data in the areas of somatic cell therapies, gene therapies, tissue-engineering, medical devices, combination products composed of cellular and medical device components, stem cells, xenotransplantation, tumor vaccines, and immunotherapy products. The candidate will do regulatory and scientific review of submissions to the FDA, with a focus on the manufacturing and control of gene therapies.

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 this collaborative and cutting-edge regulatory and scientific environment.

Qualifications: Eligible individuals must be U.S. citizens. Eligible individuals must have also completed a full 4-year course of study in an accredited college or university leading to a bachelor’s or higher degree that included a major field of study. Applicants are preferred to have an M.D. or Ph.D. or equivalent experience. Candidates should have extensive experience working with AAV vectors. Candidates with a virology background are preferred. Additional experience with assay validation, and quality systems including GMPs are also preferred but not required. Candidates should be highly motivated scientists with proven leadership skills. Candidates should also have excellent written and oral communication skills.

Salary Range: Civil Service salary range for GS-13 is $89,033.00- $115,742.00. Salary will be set commensurate with education and experience.

The candidate may also be eligible for the PHS Commissioned Corps.

Location: Rockville, MD

How to Apply:

Candidates should email a resume or curriculum vitae, bibliography, a brief summary of research accomplishments, and the names/contact information for three references by April 23, 2010 to Please reference Job Code: OCTGT-AAV.

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

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