Gene & Cell Therapy Review Scientists (Staff Fellows)

Location
Silver Spring, Maryland
Salary
Salary commensurate with education/experience.
Posted
April 26 2018
Position Type
Full Time
Organization Type
Govt.

Division of Cellular and Gene Therapy

Office of Tissues and Advanced Therapies
Center for Biologics Evaluation and Research
FOOD AND DRUG ADMINISTRATION
Department of Health and Human Services

Gene Therapies Branch and Cell Therapies Branch in Division of Cellular and Gene Therapies (DCGT), Office of Tissues and Advanced Therapies, Food and Drug Administration are recruiting full-time review scientists.  Successful candidates will perform scientific review, interpretation, and documentation of product manufacturing data to evaluate the safety and quality of gene and/or cell therapy products in regulatory submissions to FDA. Candidates are expected to be proficient in applying relevant scientific knowledge and research experience to support multi-disciplinary scientific and regulatory reviews of regulatory submissions. Successful candidates may also have opportunities to contribute to guidance and policy development activities relevant to gene and/or cell therapy.

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.

These positions will be filled through FDA's Service Fellowship program.  The appointment is for up to four years with opportunities for renewal.  Applications will be accepted from U.S. citizens or Lawful Permanent Residents (green card holders) only.  No previous 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:  Ph.D. or equivalent advanced degree in the areas specified below. Postdoctoral experience highly preferred. In addition, you must have strong collaborative skills, excellent written and oral communication skills, and evidence of leadership potential. Knowledge of federal regulations applicable to drugs, biologics, and devices is helpful but not a requirement for consideration.

  • GENE THERAPY REVIEW SCIENTIST:  Successful candidates will have a strong research background in virology, gene therapy, molecular biology, genome editing, and/or cellular/viral immunology.
  • CELL THERAPY REVIEW SCIENTIST:  Successful candidates will have a strong research background in cell therapy, cell and stem cell biology, microbiology, cellular immunology, cancer vaccine, and/or biomedical engineering.

LOCATION: FDA White Oak campus, Silver Spring, Maryland, U.S.A.

HOW TO APPLY:  Submit a statement of interest for a gene therapy or cell therapy review scientist position, 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 Ms. Teslyn Hudgins at teslyn.hudgins@fda.hhs.gov.  Applications will be accepted through June 21, 2018.  However, candidates will be considered as received.  For best consideration, please submit your application as soon as possible.

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

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