GENE & CELL THERAPY REVIEW SCIENTISTS (STAFF FELLOW)

Location
Silver Spring, Maryland
Salary
Salary commensurate with education/experience.
Posted
November 19 2018
Position Type
Full Time
Organization Type
Govt.

GENE THERAPY REVIEW SCIENTISTS (STAFF FELLOW)

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 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 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. One-year probationary period may apply.

  • GENE THERAPY REVIEW SCIENTIST:  Successful candidates will have a strong background in virology, gene therapy vectors, microbiology, molecular biology, genome editing, and/or viral immunology.

SALARY:  Salary commensurate with education/experience.

LOCATION: Silver Spring, Maryland, U.S.A.

HOW TO APPLY:  Submit a statement of interest for a gene therapy review scientist position, resume or curriculum vitae (CV) detailing relevant experience, transcripts, the names/contact information for three references, and other supporting documentations to Amy Yang at amy.yang@fda.hhs.gov . Applications will be accepted through December 14, 2018.

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