This position is being filled under a stream-lined hiring authority, Title 21, section 3072, of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured, packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.
The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net for today’s complex, global regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices, 15 laboratories, and 3 satellite laboratories throughout the United States and ports of entry. As the lead office for all FDA field activities, ORA serves as the agency’s direct connection with regulated industry through a) inspections of firms and plants producing FDA-regulated products, b) investigations of consumer complaints, emergencies and criminal activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of imported products.
The mission of the Office of Regulatory Affairs is to protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products. To view our ORA Vision, Mission, and Values please visit: https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs.
The Office of Regulatory Science (ORS) provides strategic leadership, coordination, and expertise to the Associate Commissioner for Regulatory Affairs (ACRA), Deputy Associate Commissioner for Regulatory Affairs (DACRA) and other ORA senior leaders on scientific issues related to policy and regulations.
The Office of Medical Products and Specialty Laboratory Operations (OMPSLO) advises ORS on scientific issues related to medical products, tobacco, drugs, electronic product radiation, medical devices, pharmaceuticals, radiopharmaceuticals, radionuclides in food, biological and microbiological safety of radiopharmaceuticals, and forensic chemistry.
The fundamental mission of the Detroit Laboratory (DETL) is to utilize the resources of the DETL to protect the public health by helping to assure the safety of foods, drugs and other FDA regulated products. Furthermore, DETL specializes in the testing of pharmaceutical based samples. The laboratory staff has unique expertise in the areas of drug analysis, chromatography, spectroscopy, environmental screening, and microbial analysis. In addition to scientific analysis, the laboratory staff supports the Investigations Branch in conducting pre-approval, compliance, and for cause, and surveillance inspections.
Duties/Responsibilities
The incumbent serves as the Laboratory Director within OMPSLO, ORS, ORA, and as such, the incumbent reports directly to the Deputy Associate Director, OMPSLO, and is a member of the program’s management team. Additionally, the incumbent brings to bear current scientific knowledge in analytical forensics and related technologies in making substantive decisions concerning the scientific process and work of the DETL staff and serves as the subject matter expert for ORA in the analysis and testing of pharmaceutical based samples and medical products, and the regulation of food and cosmetics.
• Advises the Deputy Associate Director, OMPSLO, and ORA leaders on new or emerging problems and trends, future program needs and priorities, manpower, equipment, financial needs, and long-range planning.
• Serves as the principal spokesperson for the DETL, the incumbent will represent the DETL as the senior scientist with both internal and external constituencies and provides executive leadership and managerial direction to the DETL scientists and support personnel.
• Responsible for developing, maintaining, and applying state of the art expertise in drug analysis and research as it applies to Agency needs, as well as providing expert advice to Agency officials as well as testimony regarding drug analysis and research issues.
• Develops and maintains the capability to respond immediately to all tampering/terrorism and other incidents, including rapid development of required new methodology, analysis of samples and critical evaluation of results.
• Designs and conducts experiments to demonstrate the physical and chemical effects of poisons on food and drug products and studies the effects of the food and drug products on the stability and toxicity of the poisons.
• Develops procedures that can be used to establish chemical profiles of poisons and other deleterious substances that might be in foods and drugs.
• Ensures that program evaluation reviews, quality assurance and quality management systems, strategies, measures, and economical operating practices are in place to promote the effective execution of work plans, conformance to policy and safe working practices.
• Develops physical, chemical, and molecular/microbiological analytical procedures that can be used to further investigations and to provide evidence in cases of fraudulent activities involving foods, drugs and other FDA regulated products.
• Develops analytical procedures that can be used to further investigations and to provide evidence in cases of fraudulent activities involving pharmaceutical products. Provides strategic leadership and support for high quality, collaborative, scientific activities, and research that advance regulatory science and address important public health issues concerning FDA regulated products, including their evaluation, quality, safety, and effectiveness. Coordinates with other Agency components (e.g., Center for Drug Evaluation and Research) on ORA scientific programs to assure a cohesive approach to public health protection.
Supervisory Responsibilities: The Laboratory Director serves as a second-level supervisor and is responsible for the effective utilization of available resources and for providing leadership, guidance, and technical direction necessary for full and effective program accomplishments of the laboratory functions. The Laboratory Director is responsible for managing all phases of laboratory analyses in connection with samples of FDA-regulated commodities assigned to the laboratory for testing and analysis. The Laboratory Director supervises a staff of professional scientists, technicians, and support positions and is responsible for the functions of the Laboratory, including: planning, scheduling, and controlling laboratory operations; and formulating, implementing, and coordinating laboratory work plans.
How to Apply
Applications will be accepted from all qualified applicants. Please email letter of interest addressing your experience in the major duties and responsibilities of the position, résumé, transcript (with foreign credentials evaluation, if applicable), and current SF-50 (redacted for birth year and SSN; applies to current federal employees only) to the ORA Executive Recruitment and Scientific Staffing Committee: ORAExecutiveAndScientificRecruitment@fda.hhs.gov.
IMPORTANT: You must reference this Job ID in the email subject line: 52-Laboratory Director, DETL
Applications will be accepted through January 31, 2024.
Announcement Contact
For questions regarding this Title 21 position, please contact ORAExecutiveAndScientificRecruitment@fda.hhs.gov
The Department of Health and Human Services is an equal opportunity employer with a
smoke-free environment.
FDA is an equal opportunity employer.