Job Description

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:

• Evaluating NGS and bioinformatics analysis data relevant to the safety of genome editing products particularly regarding off-target effects and genomic modifications Evaluating NGS and other genomics and bioinformatics datasets and pipelines relevant to the development of advanced individualized precision medicine products Assessing and ensuring data suitability for regulatory purposes, identifying critical components in the data, and determining acceptable data quality attributes and thresholds Performing independent data analyses using internally developed bioinformatics tools as well as open source and third-party genomics software and prediction algorithms Reviewing experimental design, data acquisition methods, and interpreting results Developing and implementing bioinformatics data standards and data quality assessment programs for scientific and regulatory reviews performed in CBER Communicating results and interpretation to a diverse audience, including FDA scientists, collaborators, and external stakeholders

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:

• Developing tools and/or implementing bioinformatics pipelines to analyze NGS-based assays for cell and gene therapies and genome editing   Using bioinformatics tools for identifying off-target nomination sites (e.g., GUIDE-Seq, Digenome-Seq, SITE-Seq, CIRCLE-Seq, CHANGE-Seq, PEM-Seq, DISCOVER-Seq) Using bioinformatics tools and complex analytical pipelines including diverse sequencing primary analysis tools (e.g., samtools, bedtools, GATK, BWA, Bowtie, IGV), secondary analysis tools (e.g., muTect, VarScan, VarDict), and statistical or machine learning algorithms (e.g., DESeq2, clustering, t-SNE)

• Using bioinformatics tools or pipelines for identifying and predicting neoantigens and their immunogenicity for individual cancer patients using NGS technology Using publicly available data sources (e.g., TCGA, ENCODE, 1000 Genomes, COSMIC, dbSNP, ESP, gnomAD) and diverse genomic annotations Working in the JupyterLab environment Developing and running Python code and/or R code Working in the Linux environment

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.

• One-year probationary period may be required. Official Transcripts required Background and/or Security investigation required. If applicant is an U.S. Citizen, males born on, or after, December 31st, 1959 must be registered with the Selective Service System or have an approved exemption. Visit for more info. Prohibited financial interest restrictions may apply. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at FDA Ethics and Integrity Office . The COVID-19 vaccination requirement for federal employees pursuant to Executive Order 14043, does not currently apply. Non-US and permanent residents are required to have resided in the United States for a minimum of three of the last five years .

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

Job Tags

Similar Jobs