Chemistry Branch Director at Food and Drug Administration
- Full time
- Alameda, California · On site
- USD 143,913–USD 197,200 a year
About the role
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. 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. 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.
About Food and Drug Administration
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