The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Animal Bioengineering and Cellular Therapies Team is seeking qualified applicants for the position of Interdisciplinary Scientist (Biologist/Microbiologist). The Division of Animal Bioengineering and Cellular Therapies protects public and animal health through science-based, risk-based decision making in the evaluation of animal biotechnology products that may benefit and improve the practice of both veterinary and human medicine.
As an Interdisciplinary Scientist (Biologist/Microbiologist), you will evaluate data and information related to the molecular characterization of genetic alterations in animals. In this role, you will have a significant impact on the development and approval of these FDA-regulated products that may benefit and improve the practice of both veterinary and human medicine. Specifically, you will provide expertise in the review of genomic sequencing data supporting the approval of animal biotechnology products, including but not limited to, molecular characterization of animal biotechnology, such as genetic alterations in animals and cell-based gene therapies, and data provided in support of the safety and efficacy of these products. This analysis may include comparing molecular data and information (e.g., sequencing data and/or protein-based assays) from animals with and without genetic alterations to verify the presence of the intended alteration and to determine if unintended alterations such as insertions, deletions, or structural variants were introduced during the editing or engineering of the animal’s genome. You will assist in development of new regulatory policies designed to address new challenges brought forth by the latest developments in the animal biotechnology field. You will also work closely with developers of animal biotechnology products to guide them through the unique review process associated with these products, including extensive interactions early in the development of their product and provide expertise on scientific questions and policy decisions related to the evaluation of these products. This position will be filled through FDA’s Staff Fellowship program. The appointment is up to 2 years with opportunity for renewal.
Applicants should have experience in molecular biology and bioinformatics, including in the evaluation and analysis of next generation sequencing (NGS) data or large sequence analyses or datasets that could be applied to FDA’s independent analysis of data submitted to support characterizing and evaluating the safety and/or effectiveness of animal biotechnology products.
Due to the immensity of its charge, CVM depends upon a diverse and dedicated workforce. We recognize the importance of multi-disciplinary teamwork in reaching superior and timely regulatory decisions therefore we foster an atmosphere where every employee’s contribution is important. New concepts, ideas, and creative approaches to improve current operations and to meet existing and future challenges are encouraged. Our goal is to not only enable our employees to positively impact the Center today, but to prepare our workforce for the demands, responsibilities, and career opportunities of tomorrow. ONADE offers many benefits and operates in a hoteling work environment. Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the Rockville duty station on an as-needed basis and as required and telework when not at the Rockville duty station. ONADE provides the basic technology (e.g., laptop, monitors, webcam) needed to effectively work in the Rockville office and in a teleworking location. Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization.
This position may be eligible for Remote Work. Remote work means the residence is the full-time official duty location. The difference in salary is determined by the locality pay in each location. Salaries for all areas are available on the OPM website at: www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2022/general-schedule/ . Salary range for this position is equivalent to a GS-11, Step 1 ($74,950) - GS-13, Step 12 ($138,868) in the DMV area, salaries for all localities are available on OPM website. If selected for a remote work position, you must have access to high speed internet and cell phone service meeting current Agency standards from the approved work location within the Contiguous United States and sign a remote work agreement.
Applicants should have a Ph.D. degree in microbiology, or biological sciences or a combination of relevant education and experience. Candidates should demonstrate proficiency in scientific writing and communication skills. Experience analyzing the results of experiments to determine whether data generated are accurate and valid, determining and/or utilizing appropriate analytical methods (e.g., statistical analyses, mathematical models) to analyze research data, interpreting applicable scientific literature and study results to draw conclusions and make recommendations, and supporting all conclusions and recommendations with a scientific rationale. Further information regarding qualification requirements can be found at the following link:
Biologist:
www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/general-natural-resources-management-and-biological-sciences-series-0401/.
Microbiologist:
www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/microbiology-series-0403/
Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “Division of Animal Bioengineering and Cellular Therapies Interdisciplinary Scientist (Biologist/Microbiologist) Staff Fellow Position”. Questions may also be directed to the CVM Opportunities mailbox.
Applications will be accepted February 9, 2023, through April 9, 2023.
**Applications will be reviewed, and interviews will be scheduled on a first come, first serve basis.**
Applicants should have a Ph.D. degree in microbiology, or biological sciences or a combination of relevant education and experience. Candidates should demonstrate proficiency in scientific writing and communication skills. Experience analyzing the results of experiments to determine whether data generated are accurate and valid, determining and/or utilizing appropriate analytical methods (e.g., statistical analyses, mathematical models) to analyze research data, interpreting applicable scientific literature and study results to draw conclusions and make recommendations, and supporting all conclusions and recommendations with a scientific rationale. Further information regarding qualification requirements can be found at the following link:
Biologist:
www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/general-natural-resources-management-and-biological-sciences-series-0401/.
Microbiologist:
www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/microbiology-series-0403/
Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “Division of Animal Bioengineering and Cellular Therapies Interdisciplinary Scientist (Biologist/Microbiologist) Staff Fellow Position”. Questions may also be directed to the CVM Opportunities mailbox.
Applications will be accepted February 9, 2023, through April 9, 2023.
. **Applications will be reviewed, and interviews will be scheduled on a first come, first serve basis.**