Individualized Cell and Gene Therapies and Cancer Immunotherapies
OFFICE OF TISSUES AND ADVANCED THERAPIES
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 a full-time Bioinformatics Reviewer to fill a staff fellow position.
DCGT is strongly committed to bringing scientists, patient advocates, and the public together in partnership to foster the development of novel advanced therapies for the 21st Century, while protecting human subjects and ensuring product safety and quality.
The selected candidate will be a part of a cutting-edge and fast-paced scientific and regulatory environment. The candidate will work with a dynamic team of multi-disciplinary scientists and apply bioinformatics expertise to perform assessments of scientific and regulatory information of cell and gene therapy products including neoantigen-derived cancer immunotherapy products submitted to OTAT. The candidate 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 and immunotherapy products.
RESPONSIBILITIES: As Bioinformatics Reviewer, the candidate will perform the following major duties:
• Evaluating NGS and other genomics and bioinformatics datasets and pipelines relevant to the development of advanced individualized cell and gene therapy and immunotherapy products submitted to OTAT.
• Developing and implementing bioinformatics data review framework and data quality assessment standards for regulatory and scientific review of the biological drug 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 perform bioinformatics data analysis using internally developed tools as well as open source and third-party genomics software and prediction algorithms.
• Communicating results and interpretation to a diverse audience, including FDA scientists, academia, industry, and other external stakeholders.
CONDITIONS OF EMPLOYMENT: This position will be filled through the Service Fellowship program, with an initial appointment period followed by 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.
• 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.
BASIC QUALIFICATIONS: This position is multidisciplinary, and applicants will be required to meet the one of the specific qualification requirements of the applicable occupational series below.
General Natural Resources Management and Biological Sciences (RG-0401): Degree in Biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position, – OR – Combination of education and experience in courses equivalent to a major, plus appropriate experience or additional education.
Microbiology (RG-0403): Degree in microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent. – OR – Combination of education and experience in courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above, plus appropriate experience or additional education.
Computer Scientist (Bioinformatics 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, Computer Science, Genomics, Biology, or a related field is 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 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.
• Familiarity with the JupyterLab environment
• Python and/or R (additional languages such as C++,C, or Java are a plus)
• Comfortable 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.
HOW TO APPLY: Submit your 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 bioinformatics reviewer position, and the names/contact information of three references to Manuel Machin at Manuel.Machin@fda.hhs.gov. Applications and all supporting documentation will be accepted through July 26, 2022. Please reference Job Code: OTAT-22-17-SCB.