Lab Chief
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 the 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 announcement here: https://www.fda.gov/media/159552/download
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of human pharmaceutical quality within CDER, including submission review, manufacturing facility assessment, and surveillance of the quality of marketed pharmaceutical products. The Office of Testing and Research (OTR) conducts laboratory research on manufacturing, formulation, and characterization of drugs, and provides advice/consults, collaborative research opportunities, and scientific training to FDA staff on pharmaceutical quality, pharmaceutical equivalency, and bioavailability/bioequivalence issues including manufacturing, formulation, analytical testing, and modeling.
Duties/Responsibilities
As the Lab Chief, the incumbent serves as a senior advisor to the Deputy Director and plans, manages, organizes, and directs all laboratory functions, surveillance testing, and laboratory-based investigational activities as carried out by a highly trained and skilled staff of scientific professionals. The Lab Chief leads scientists who conduct experiments to understand the impact of changes in specification of drug substance and ingredients, formulation, packaging, manufacturing equipment, and processes on product quality attributes. The Lab Chief leads staff involved in safety, integrated quality assessment systems, facilities and equipment maintenance, and shipping and receiving activities.
- Collaborates with Office leadership to formulate and develop short-term and long-range new drug quality assessment goals, policies, and standards.
- Oversees and participates in an active research program and/or directs research scientists engaged in a broad range of pharmaceutical quality research designed to ensure drug quality, safety, and efficacy.
- Supports a lifecycle approach to drug application approval by providing relevant expertise and laboratory data to aid quality assessment of supplements and abbreviated new drug applications.
- Serves as a subject matter expert and source of informed opinion and information on scientific matters related to drug quality including drug delivery, biopharmaceutics analytics, formulation, and manufacturing.
Supervisory Responsibilities: Manages the functional discipline, providing leadership and management oversight to subordinate staff. Supervises and evaluates staff of experts in their field. Provides occupational specific technical, administrative direction and supervision 25 percent or more of the time to subordinate staff performing the work and functions of the organizational unit. Obtains resources and identifies strategic objectives for the organization.
Qualifications
To be placed into a Cures position, candidates must meet the following criteria:
- Scientific, Technical, and Professional Fields
- Qualified and Outstanding Candidates
- Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
- Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.
To qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.
Education Requirement:
Natural Resources Management and Biological Sciences Series, AD-0401:
Degree: biological sciences, agriculture, natural resource management, chemistry, or related
disciplines appropriate to the position. Or a combination of education and experience with
courses equivalent to a major listed, plus appropriate experience or additional education.
General Physical Science Series, AD-1301:
Degree: physical sciences, engineering, or mathematics that included 24 semester hours in
physical science and/or related engineering science such as mechanics, dynamics, properties of
materials, and electronics. Or a combination of education and experience with education
equivalent to one of the majors listed that included at least 24 semester hours in physical
science and/or related engineering science, plus appropriate experience, or additional
education.
Chemistry Series, AD-1320:
Degree: physical sciences, life sciences, or engineering that included 30 semester hours in
chemistry, supplemented by course work in mathematics through differential and integral
calculus, and at least 6 semester hours in physics. Or a combination of education and
experience with course work equivalent to a major listed, 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.
Desired Education: A minimum of 3 years of progressively higher-level graduate education leading to a Ph.D. degree, Ph.D., or equivalent doctoral degree.
Desired Professional Experience:
Our ideal candidate will possess:
- Demonstrated leadership experience in diverse organizational.
- Demonstrated ability to apply knowledge of regulatory assessment process and project management skills (e.g., ability to organize time effectively, determine priorities, and create a path forward).
- Demonstrated ability to develop networks and build alliances. Experience collaborating across boundaries to build strategic relations and achieve common goals.
- Demonstrated ability to identify internal and external politics that impact the work of the organization, including perceiving organizational and political reality to create a path forward.
- Demonstrated ability to identify and analyze problems; weights relevance and accuracy of information; generates and evaluates alternative decisions; makes recommendations.
- Successful experience in organizational change management.
- Expert ability to communicate, verbally and in writing, and work with staff at all levels of the organization and varying levels of domain expertise; excellent listening skills, and a commitment to communicate in a timely manner.
- Ability to work independently and as a contributing and collaborative team member.
- Ability to organize time effectively, determine priorities, and move work forward.
How to Apply
All qualified candidates should submit their resume with cover letter and unofficial transcripts (if you have foreign transcripts please submit a course-by-course foreign evaluation from an accredited company (NACES or AICE) by July 7, 2022 to: OPQOTRRecruitment@fda.hhs.gov. Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.
Please reference Job Reference ID: OTR Lab Chief
Announcement Contact
For questions regarding this Cures position, please contact Dominique.Mitchell@fda.hhs.gov.
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate.