Biologist-Staff Fellow RG-GS 11/12/13
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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 several Biologist positions. The Team protects public and animal health through science and risk based decision making in the evaluation of animal biotechnology and cell-based products for veterinary use. In this role, you will have a significant impact on the development and approval of these FDA-regulated articles that may benefit and improve the practice of both veterinary and human medicine. Specifically, you will provide cellular and molecular biology expertise in the review of data supporting the approval of animal biotechnology products and cell-based products, including but not limited to, characterization of the cell product, gene therapy, or animal biotechnology product and data provided in support of the claims associated with these products. You will assist in development of new regulatory policies designed to address new challenges brought forth by the latest developments in the animal biotechnology and regenerative medicine fields. You will also work closely with developers of animal biotechnology and cell-based products to guide them through the unique approval 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 performing weight of evidence, risk-based evaluations of data and information relevant to cell-based products and animal biotechnology such as stem cell biology, functional cell assays, immunology, comparability of cell products, genome editing, genetic engineering, and gene drives; evaluating the safety and/or effectiveness of biotechnology and cell-based products; evaluating the characterization of these products; and evaluating current guidelines and policies for relevance to the biotechnology and regenerative medicine fields.
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 (when in person attendance is deemed important and regardless of need, no less than 2 days per pay period). Applicants should be located in, or willing to relocate to, the greater Washington DC area. 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.
The position is located in Rockville, Maryland and is available immediately. The position can be filled at the GS-11, GS-12 or GS-13 equivalent level based on experience and education. The salary range for the GS-11 equivalent level is $68,036 to $88,450, GS-12 equivalent level is $81,548 to $106,012 and for the GS-13 equivalent is $96,970 to $126,062. Further qualification requirement information can be found at the following link: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/general-natural-resources-management-and-biological-sciences-series-0401/.
The vacancy announcement will close June 18th. **Applications will be reviewed and interviews will be scheduled on a first come, first serve basis.**
Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “ABCTT Biologist”. Questions may also be directed to the CVM Opportunities mailbox.
FDA is an equal opportunity employer and is a smoke-free environment.