Chemistry Branch Director

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 D.

Duties

Plans, schedules, and controls laboratory unit operations by implementing a coordinated laboratory work plan in cooperation with other ORTS laboratory facilities, including national surveillance programs for identifying potential problems or trends. Supervises laboratory analysis of regulated product samples to assess compliance with laws and regulations enforced by FDA, and provides evidence regarding analytical findings as requested by regulatory and enforcement officials. Ensures quality system compliance by actively supporting a robust, documented Quality System in accordance with ISO 17025 and AOAC standards, including development of standard operating procedures and statistically derived quality control parameters. Manages branch resources, including laboratory equipment, instrumentation, supplies, and chain-of-custody procedures for regulatory samples; identifies resource needs and coordinates with the Laboratory Director for procurement and allocation. Exercises supervisory authority over branch employees, including assigning and reviewing work, evaluating performance, recommending promotions and recognition, approving leave, and taking corrective actions as appropriate. Provides technical leadership by mentoring branch personnel, implementing best practices in analytical chemistry and laboratory quality management, and serving as the principal scientific authority for the branch. Represents ORTS at national meetings, conferences, and forums with FDA Centers, other agencies, industry, and academia; provides authoritative technical advice and testimony relating to laboratory analytical findings and compliance determinations. Identifies and mitigates risks to branch program success, including laboratory safety compliance, quality system risk controls, and chain-of-custody integrity. Qualifications

In order to qualify for the Chemistry Branch Director position which falls under the 1320 occupational Series, you must meet the following requirements by 11:59 pm EST on 08/29/2026: Basic Qualification Requirements: Have a bachelor's degree or higher in chemistry, biochemistry, or chemical engineering OR Combination of education and experience -- course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education. IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. Have a bachelor's degree and 5 years comparable experience directing or supervising a team of scientific professionals conducting chemical analysis of food, drug, cosmetic, or other regulated products in a regulatory or public health laboratory setting; AND experience developing, validating, or overseeing the implementation of analytical chemistry methods in accordance with established quality system requirements (such as ISO 17025 or AOAC standards); AND experience applying laws, regulations, or regulatory science principles governing the testing and surveillance of FDA-regulated or similarly regulated products. OR Have a master's degree and have 4 years of comparable experience directing or supervising a team of scientific professionals conducting chemical analysis of food, drug, cosmetic, or other regulated products in a regulatory or public health laboratory setting; AND experience developing, validating, or overseeing the implementation of analytical chemistry methods in accordance with established quality system requirements (such as ISO 17025 or AOAC standards); AND experience applying laws, regulations, or regulatory science principles governing the testing and surveillance of FDA-regulated or similarly regulated products. OR Have a Doctorate and/ or JD degree and have 2 years of comparable experience directing or supervising a team of scientific professionals conducting chemical analysis of food, drug, cosmetic, or other regulated products in a regulatory or public health laboratory setting; AND experience developing, validating, or overseeing the implementation of analytical chemistry methods in accordance with established quality system requirements (such as ISO 17025 or AOAC standards); AND experience applying laws, regulations, or regulatory science principles governing the testing and surveillance of FDA-regulated or similarly regulated products OR Have a MD, DO, DDS, DPM, or DVM degree .and have 2 years of comparable experience directing or supervising a team of scientific professionals conducting chemical analysis of food, drug, cosmetic, or other regulated products in a regulatory or public health laboratory setting; AND experience developing, validating, or overseeing the implementation of analytical chemistry methods in accordance with established quality system requirements (such as ISO 17025 or AOAC standards); AND experience applying laws, regulations, or regulatory science principles governing the testing and surveillance of FDA-regulated or similarly regulated products. 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. 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. How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above. This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. Please follow all instructions carefully. Errors or omissions may affect your eligibility. Other 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: No 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 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. Active-duty U.S. Public Health Service Commissioned Corps Officers are encouraged to apply. If selected, officers may either (1) remain on active duty assigned to the designated billet for PHS assignment, or (2) separate or retire from the Commissioned Corps before entering a Title 21 civilian appointment. All requirements must be met by the closing date of this announcement (08/29/2026); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.