Description of Duties
Review and evaluate chemistry, formulation, manufacturing, controls, and biopharmaceutics including drug releases, technical aspects of labeling and environmental impact information submitted in various drug applications and supplements (i.e., BLAs, NDAs, ANDAs, and INDs).
- Evaluate the adequacy of testing and control of container closure systems, starting and intermediate materials, reagents, and solvents.
Establish clinically relevant quality standards to ensure its clinical performance for approval to market and for the entire lifecycle of the drug product.
Assess the adequacy of pharmaceutical manufacturing; and, products usability and acceptability to the patient.
Evaluate the adequacy of analytical methods and validation reports used during synthesis, characterization, manufacture, release and stability testing of drug substances and drug products.
Communicate review outcomes including any identified deficiencies or issues, established policy and any further requests through oral and/or written communication.
Basic requirements for all grades in this position include:
- A degree in physical sciences, life sciences, or engineering, which includes 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus and at least 6 semester hours of physics
- A combination of education and experience-course work equivalent to a major as described above, plus appropriate experience or additional education.
Grade (Salary) Levels
Federal General Schedule (GS) grade levels at which chemist positions are commonly filled are:
- GS-9 through 13 at the headquarters level
- GS-5 through 12 at the field level
Qualifying for higher-graded positions requires additional amounts of either specialized experience or directly related education. The amount of additional experience or education required depends on the grade of the position.
Chemists are located at HQ (suburban Washington, D.C.) and in facilities throughout the U.S.