Human Tissues & Biologics Safety
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 a Principal Investigator with a strong background and expertise in infectious diseases, microbiology, tissue safety, high-throughput technologies and bioinformatics, human tissue properties, function and availability, and related fields.
The successful candidate will lead the human tissue laboratory to evaluate, develop and adopt novel technologies to support the safety and performance of products sourced from human cells, tissues, and cellular and tissue-based products (HCT/Ps) by OTAT. The candidate will have opportunities to contribute to FDA policy and guidance development activities related to human tissues, and to participate in the regulatory review of chemistry, manufacturing and control (CMC) information for cellular and gene therapy products regulated by DCGT.
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. The successful candidate will be a part of a cutting-edge and fast-paced scientific and regulatory environment.
RESPONSIBILITIES: The selected candidate will be responsible but not limited to the following:
- Establishing and maintaining a human tissue laboratory to perform research in field(s) including infectious diseases, microbiology, tissue safety, high-throughput technologies and bioinformatics, human tissue properties, functions, and availability.
- Developing new methods and technologies to support human tissue safety and successful functions in clinical use.
- Developing and maintain capabilities using various high-throughput platforms useful in genomic sequencing, metagenomics and microbiome analysis, to examine HCT/Ps for harmful or beneficial microbes.
- 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 one of the 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.
Microbiology, RG-403: Degree in Microbiology; or biology, chemistry, or basic medical science that include at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in 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--courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that include course as shown above, plus appropriate experience or additional education.
ADDITIONAL QUALIFICATIONS: Ph.D., M.D., or an equivalent degree in Microbiology, Infectious Diseases, Medical Science, Biological 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.
PREFERRED SPECIALIZED EXPERIENCE:
- Demonstrated experience in clinical microbiology and infectious diseases.
- R&D experience in clinical microbiology and NGS technology.
- Hands-on experience in commercial and open-source bioinformatics for the detection and characterization of microbial agents using NGS technology.
- Experience in identifying and characterizing previous unknown and emerging infectious agents.
- Experience with analysis of tissues and their properties.
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. Also, an excellent benefit package is available.
LOCATION: FDA White Oak Campus in 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.
- 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 Susan Roman at Susan.Roman@fda.hhs.gov. Applications and all supporting documentation will be accepted through February 28, 2021; however, applications received after the deadline may still be considered. Please reference Job Code: OTAT-21-06-CJP.
DEPARTMENT OF HEALTH AND HUMAN SERVICES IS AN EQUAL OPPORTUNITY EMPLOYER WITH A SMOKE FREE ENVIRONMENT