Laboratory Director, FCC

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

VIEW FULL VACANCY ANNOUCEMENT HERE: https://www.fda.gov/media/164064/download

Introduction

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices 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 multibillion-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.

FDA’s Office of Regulatory Affairs (ORA) is the lead office for all agency regulatory activities. Over 5,000 ORA employees strategically located in district offices, resident posts, and laboratories throughout the United States perform inspections and investigations (including criminal investigations), wharf exams, sample collections and analyses, and carry out enforcement activities, education, and outreach directly to consumers, industry representatives, importers, and shippers as well as other stakeholders across the nation. ORA also works with its federal, state, local, tribal, territorial, and foreign counterparts to further the agency’s mission. ORA is led by the Associate Commissioner for Regulatory Affairs (ACRA).

To view our ORA Vision, Mission, and Values please visit:

https://www.fda.gov/about-fda/office-regulatory-affairs/ora-vision-mission-and-values.

The Office of Medical Products and Specialty Laboratory Operations (OMPSLO) advises the Office of Regulatory Sciences (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 Forensic Chemistry Center (FCC), a laboratory located within the OMPSLO. The core functions of the FCC laboratory involve essential laboratory analyses and research services involving FDA-regulated commodities to protect the public health and safety. This highly technical laboratory has broad functional responsibilities and scope in program areas that include both criminal and regulatory testing and research involving human and veterinary drugs, food and feed, devices, cosmetics, and biological products. Laboratory findings may result in criminal prosecutions and/or regulatory decisions/actions that directly affect consumers, businesses and industries involved with FDA regulated products on a national scale. This laboratory has a unique national and international responsibility intended to support the Agency's public health mission and forensic chemistry requirements on a world-wide basis. The laboratory also has responsibility for a satellite laboratory program at selected ports of entry.

Duties/Responsibilities

The Director is responsible for providing leadership, guidance, and technical direction necessary for full and effective program accomplishments and the effective utilization of available resources. The Director manages all phases of laboratory analyses assigned to the FCC for testing and research to develop and refine methodology used in the analysis of evidence and to explore new systems of laboratory analysis. The Director is responsible for planning and implementing scientific programs, criminal and regulatory analysis, and scientific research associated with the chemical, biological and microbiological examination of regulated products. The Director plays a major role in national policy determination through the selection of test methods employed and development of scientific data to support risk assessment in public health crises investigations associated with regulated commodities. This position is responsible to the Associate Director, OMPSLO, for the effective utilization of available resources and for providing leadership, guidance, and technical direction necessary for full and effective program accomplishments. Incumbent brings to bear current scientific knowledge in the field of specialty and related technologies in making substantive decisions concerning the scientific process and work of the laboratory staff under the direction of the incumbent.

Supervisory Responsibilities:

• Supervises three branches with a staff of professional, technical, and support staff performing up to the GS-15 level to accomplish the work of the Center.

• Exercises third-level supervisory authorities and responsibilities involving work assignment and review over subordinate branches as well as administrative and personnel management functions relative to subordinates.

• Performs the administrative and personnel management functions relative to staff supervised.

• Establishes guidelines and performance expectations for staff, which are clearly communicated through the formal employee performance management system. Observes workers’ performance; demonstrates and conducts work performance critiques. Provides informal feedback and periodically evaluates employee performance. Resolves informal complaints and grievances. Develops work improvement plans, recommending personnel actions as necessary.

• Provides advice and counsel to workers related to work and administrative matters. Effects disciplinary measures as appropriate to the authority delegated in this area. Reviews and approves or disapproves leave requests. Assures that subordinates are trained and fully comply with the provisions of the safety regulations and the Laboratory Quality Assurance Program.

How to Apply

Applications will be accepted from all qualified internal and external applicants. Please send letter of interest addressing your experience in the major duties and responsibilities of the position, detailed resume and bibliography, redacted SF-50 for current federal employees only, transcript (with foreign credentials evaluation, if applicable) to the ORA Executive Recruitment and Scientific Staffing Committee, oraexecutiveandscientificrecruitment@fda.hhs.gov. Applications will be accepted through January 19, 2023. Please reference Job Reference ID: Laboratory Director, FCC

Announcement Contact

For questions regarding this Cures 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.