Summary 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. Responsibilities 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. Requirements Conditions of Employment Qualifications 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. Education Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements. TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. See the Application Manager Documentation for tips on submitting your paper-based documents. 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. To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The @type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below: National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation. Additional Information The application limit, if applicable, for this advertisement is: No Limit. Additional Conditions of Employment: Pre-employment physical required: No Drug testing required: No License required: No Mobility agreement required: No Immunization required: No Bargaining Unit: N/A Telework eligible position: Telework is at the discretion of the supervisor. Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position. This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. Additional Information: Additional selections may be made for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc. If you are serving, or have served in the last 5 years (from 07/14/2025) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment @types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more. Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring. To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring. All requirements must be met by the closing date of this announcement (07/14/2025); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.
