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  1. Center for Biologics Evaluation and Research (CBER)

Staff Fellow – Bioinformatics (Individualized Cell and Gene Therapies)

OFFICE OF TISSUES AND ADVANCED THERAPIES (OTAT)
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
FOOD AND DRUG ADMINISTRATION (FDA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Cellular and Gene Therapies (DCGT)  is recruiting to fill (2) Staff Fellow positions.

DCGT 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. Successful candidates will be a part of a cutting-edge and fast-paced scientific and regulatory environment.

Successful candidates will work with a team of dynamic multi-disciplinary scientists and apply bioinformatics expertise to perform assessments of scientific and regulatory information of cell and gene therapy products submitted to OTAT. The candidates may also have opportunities to contribute to FDA policy and guidance development activities in the bioinformatics area relevant to the regulation of innovative individualized cell and gene therapy products.

RESPONSIBILITIES: The selected candidate will be responsible for:

  • Developing and implementing bioinformatics data standards and data quality assessment programs for scientific and regulatory review of the submissions to OTAT
  • Establishing targets (desired state of specific data quality attributes) and thresholds (minimum level of quality acceptable) to assess and ensure data fitness for regulatory purposes
  • Independently performing bioinformatics data analysis using internally developed tools as well as open source and third-party genomics software and prediction algorithms
  • Evaluating NGS and other genomics and bioinformatics datasets and pipelines relevant to the development of advanced individualized cell and gene therapy products submitted to OTAT
  • 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 the applicable occupational series below.

General Natural Resources Management and Biological Sciences (0401): Degree in Biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position, – OR – Combination of education and experience: Courses equivalent to a major, plus appropriate experience or additional education.

Computer Scientist, RG-1550: Bachelor's degree in computer science or bachelor's degree with 30 semester hours in a combination of mathematics, statistics, and computer science. At least 15 of the 30 semester hours must have included any combination of statistics and mathematics that included differential and integral calculus. All academic degrees and course work must be from accredited or pre-accredited institutions.

ADDITIONAL QUALIFICATIONS: Ph.D. degree in Bioinformatics, Computational Biology, Genetics, Computer Science or a related field required. Candidate must have strong collaborative skills, excellent written and oral communication skills, and a clear evidence of leadership potential. Knowledge of federal regulations applicable to drugs and biological products is helpful but not required for consideration. R&D experience in personalized neoantigen-based cancer immunotherapy products is a plus.

PREFERRED SPECIALIZED EXPERIENCE:

  • 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).
  • Commercial and open-source bioinformatics, BioCompute Object, and genomics analysis software (e.g., FDA HIVE, DNA-Nexus, CLCBio, Galaxy).
  • Creating bioinformatics pipelines identifying and predicting neoantigens and their immunogenicity for individual cancer patients based on NGS sequencing technology.
  • Publicly available data sources (e.g., TCGA, ENCODE, 1000 Genomes, COSMIC, ESP) and diverse genomic annotations.
  • R and/or Python or C++

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 www.SSS.gov 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.

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 Diamond Thomas at Diamond.Thomas@fda.hhs.gov. Applications and all supporting documentation will be accepted through June 30, 2020.  Please reference Job Code: OTAT-20-05-CJP.

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.

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