The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Animal Bioengineering and Cellular Therapies (DABCT) is seeking qualified applicants for the position of Biologist. The Division protects public and animal health through science and risk-based decision making in the evaluation of animal biotechnology and cell- and tissue-based products for veterinary use.
As a member of this Division, 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 biology expertise in the review of data supporting the approval of animal cell- and tissue-based products, including but not limited to, data supporting the characterization, comparability, safety, and effectiveness of the product.
- 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 cell- and tissue-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.
- You will collaborate with colleagues in FDA and other Federal agencies on interrelated programs.
Applicants should have a Ph.D. degree in biological sciences and a combination of relevant education and experience. Candidates should demonstrate proficiency in scientific writing and communication skills. Experience performing weight of evidence, risk-based evaluations of data and information relevant to cell- and tissue-based products such as stem cell biology, functional cell assays, immunology, comparability of cell- and tissue-products; evaluating donor selection criteria and infectious disease testing methods,; evaluating the safety and/or effectiveness of cell- and tissue-based products including methods for evaluating the immunogenicity and tumorigenicity risks; evaluating the characterization of these products; evaluating products for public health hazards; and evaluating current guidelines and policies for relevance to the biotechnology and regenerative medicine fields.
The position is located in Rockville, Maryland and is available immediately. The position will be filled through FDA’s Staff Fellowship program. Appointments will be made up for up to two years with opportunities for renewal. Applicants are required to live in, or be willing to relocate to, the greater Washington DC area. The salary range is $86,335 to $133,465 based on experience and education. Further information regarding qualification requirements 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/.
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.
Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “DABCT Biologist Staff Fellow Position – Working at CVM” Questions may also be directed to the CVM Opportunities mailbox.
**Applications will be reviewed and interviews will be scheduled on a first come, first serve basis.**
FDA is an equal opportunity employer and is a smoke-free environment.