Office of Cellular Therapy and Human Tissue (OCTHT)
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 Cellular Therapy and Human Tissue (OCTHT) is recruiting Bioinformatics Review Scientists as Staff Fellows.
OCTHT is strongly committed to bringing scientists, patient advocates, and the public together in partnership to develop novel advanced therapies for the 21st Century, while protecting human subjects and ensuring product safety and quality. OCTHT oversees the development and regulation of a wide variety of cutting-edge biological products including cell therapy products, tissue-engineered products, gene therapy products, and medical devices used in the production of these products. Review Scientists are an integral part of OCTHT’s fast paced regulatory science review and oversight program.
Successful candidates will work with a team of dynamic multi-disciplinary scientists and clinicians and apply bioinformatics expertise to perform assessments of scientific and regulatory information of cell and gene therapy products including genome editing products submitted to CBER. The candidates may also have opportunities to contribute to the development of FDA’s regulatory policy and guidance on bioinformatics in emerging therapeutic areas such as genome editing products, next-generation sequencing (NGS)-based precision medicine, and individualized cancer vaccines.
RESPONSIBILITIES: The selected candidate will be responsible for:
BASIC QUALIFICATIONS: This position is multidisciplinary, and applicants will be required to meet the specific qualification requirements of one of the applicable occupational series: General Natural Resources Management and Biological Sciences (RG-0401) , Microbiology (RG-0403) , Computer Science, RG-1550 , Statistics (RG-1530).
ADDITIONAL QUALIFICATIONS: Ph.D. degree in Bioinformatics, Computational Biology, Genetics, Computer Science, Genomics, Biology, Statistics, or a related field is required, and a strong publication record is preferable. Candidate must have strong collaborative skills, excellent written and oral communication skills, and show clear evidence of leadership potential. Additionally, candidates who have a good general understanding of cell biology, molecular biology, and human genetics are preferred. Knowledge of federal regulations applicable to biological products and drugs is helpful but not required for consideration. Research and development (R&D) experience in genome editing- or NGS-based therapeutics is a plus; but, this not an R&D position.
PREFERRED SPECIALIZED EXPERIENCE:
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.
LOCATION: Silver Spring, MD
CONDITIONS OF EMPLOYMENT: This position will be filled through the Service Fellowship program. The appointment provides up to (4) years with opportunities for renewal. Applications will ONLY be accepted from U.S. citizens and/or permanent residents (green card). 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.
HOW TO APPLY: Submit electronic resume or curriculum vitae with a cover letter containing a brief summary of career interest and scientific accomplishments, a statement of how your education and experience would be applicable to this position, and the names/contact information of three references to Rebecca Escobar at [email protected] . Applications and all supporting documentation will be accepted through January 10, 2025 . Please reference Job Code: OTP-25-01-FDA
ADDITIONAL INFORMATION: For additional information on CBER Careers, please visit:
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES IS AN EQUAL OPPORTUNITY EMPLOYER WITH A SMOKE FREE ENVIRONMENT
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