What are the responsibilities and job description for the Supervisory Pharmaceutical Scientist position at FDA Center for Drug Evaluation and Research?
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 E.
Basic Qualification Requirements: A bachelor's degree or higher in pharmaceutical science, pharmaceutical engineering, pharmacology, chemistry, biology, microbiology, chemical engineering, biochemical engineering, biomedical engineering, pharmacy, biochemistry, molecular biology, physical sciences, life sciences, engineering, mathematics, PharmD, biological sciences, agriculture, natural resource management. The degree must be from an accredited program or institution.
-OR-
Have a minimum of nine (9) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
AND
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 also have six (6) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
OR,
Have a master's degree and also have five (5) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
OR,
Have a Doctorate and/or J.D. degree and also have three (3) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
OR,
Have a MD, DO, DDS, DPM, or DVM degree and also have three (3) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
OR,
Have nine (9) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Qualifications:
In order to qualify for the Supervisory Pharmaceutical Scientist position which falls under the 0601 occupational series, you must meet the following requirements by 11:59 pm EST on 06/12/2026:Basic Qualification Requirements: A bachelor's degree or higher in pharmaceutical science, pharmaceutical engineering, pharmacology, chemistry, biology, microbiology, chemical engineering, biochemical engineering, biomedical engineering, pharmacy, biochemistry, molecular biology, physical sciences, life sciences, engineering, mathematics, PharmD, biological sciences, agriculture, natural resource management. The degree must be from an accredited program or institution.
-OR-
Have a minimum of nine (9) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
AND
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 also have six (6) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
OR,
Have a master's degree and also have five (5) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
OR,
Have a Doctorate and/or J.D. degree and also have three (3) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
OR,
Have a MD, DO, DDS, DPM, or DVM degree and also have three (3) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
OR,
Have nine (9) years of relevant experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Responsibilities:
- Serves as a senior advisor to the Division 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.
- 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.
- Provides input to the Division Director to formulate and develop short term and long range new drug quality assessment goals, policies, and standards.
- Assigns and manages projects based upon the degree of risk to product quality and public health impact.
- Supports a lifecycle approach to drug application approval by providing relevant expertise and laboratory data to aid quality assessment of drug applications.
- Manages and participates in an active research program and/or supervises research scientists engaged in a broad range of pharmaceutical quality research designed to ensure drug quality, safety, and efficacy.
- Manages the functional discipline and provides leadership and management oversight to subordinate staff.
Salary : $169,279