This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band B.
In order to qualify for the Biologist position which falls under the 0401 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/14/2025: Basic Qualification Requirements: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/general-natural-resources-management-and-biological-sciences-series-0401/ Have a degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. OR Have a combination of education and experience in courses equivalent to a major, as shown in above, plus appropriate experience or additional education. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. AND IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. IF USING EDUCATION IN COMBINATION, TRANSCRIPT WILL BE REQUIRED. Have a bachelor's degree and have 3 years of comparable experience in the scientific review of submissions related to food additives, color additives, generally recognized as safe (GRAS) substances, food contact substances, or food derives from new plant varieties and foods derived through innovative technologies. OR Have a master's degree and have 2 years of comparable experience in the scientific review of submissions related to food additives, color additives, generally recognized as safe (GRAS) substances, food contact substances, or food derives from new plant varieties and foods derived through innovative technologies. OR Have a Doctorate and/or J.D. degree and have 1 years of comparable experience in the scientific review of submissions related to food additives, color additives, generally recognized as safe (GRAS) substances, food contact substances, or food derives from new plant varieties and foods derived through innovative technologies. OR Have a MD, DO, DDS, DPM, or DVM degree. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Conducts safety assessments of dietary supplements, food additives, color additives, food contact substances, GRAS ingredients, or contaminants. Coordinates with other scientists in OFCSDSI. Serve as liaison between the OFCSDSI evaluation teams and provides consultation support to FDA Office of Inspections and Investigations as needed. Conducts reviews in terms of content, policy, and program objectives. Helps coordinate the development of policy, regulations, guidelines, and other actions involving the assessment of dietary supplements, food additives, color additives, food contact substances, GRAS ingredients, or contaminants. Ensures that official record of safety assessments is complete. Evaluates large and complex data and information across a broad area of biological sciences to determine which data are relevant and of suitable quality to support regulatory decisions and actions on dietary supplements, food additives, color additives, food contact substances, GRAS ingredients, or contaminants from a variety of sources. The incumbent makes recommendations to supervisor that have a direct impact on the basic content and character of work results. Provides a) scientific and technical support on emerging food chemical safety and technology issues, b) regulatory review activities to ensure that documents that are developed adequately address the issues, are timely, scientifically sound and reflect a correct interpretation of FDA statutes, policies, and applicable regulations, and c) technical and policy input on proposed regulatory actions to other OFCSDSI divisions/teams, and other offices in the HFP. Provides sound advice on regulatory policy issues, guidance and participates in the resolution of such issues within the office or other HFP offices and FDA. Responsible for writing briefing documents and options papers that provide clear and concise information for Office and HFP leadership on the safety, regulatory status, and risk management options. Provides scientific guidance and advice in the area(s) of the safety of dietary supplements, substances added to food or that come into contact with food, or contaminants to the Office, HFP, Agency, universities, foreign governments, private industry, and other Federal agencies, on the safety of dietary supplements, food additives, color additives, food contact substances, and GRAS ingredients. Provides technical assistance and advice to industry, academia, other public health officials in state and local government agencies, as well as consumers regarding the safety assessment of dietary supplements, food additives, color additives, food contact substances, GRAS ingredients, or contaminants. Interprets and provides recommendations in consultation with their supervisor on policy options consistent with laws and regulations, and to make procedural recommendations. Identifies scientific data available to support regulatory determinations.