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 C.
In order to qualify for the Pharmaceutical Scientist position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/14/2025: Basic Qualification Requirements: A bachelor's degree or higher in pharmaceutical science, pharmaceutical engineering, pharmacology, chemistry, biology, microbiology, chemical engineering, biochemical 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- Six (6) years of 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. IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. 1. Have a bachelor's degree and also have four (4) years of comparable 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. 2. Have a master's degree and also have three (3) years of comparable 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. 3. Have a Doctorate and/or J.D. degree and also have one (1) years of comparable 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. 4. Have a MD, DO, DDS, DPM, or DVM degree. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Formulates recommendations and decisions in areas where precedents and guidelines are inadequate, utilizing scientific background and understanding of broad legislation, policy statements, and regulatory program definitions. Evaluates the identification and characterization of drug substance's pharmaceutical properties and their impact on the drug products performance, manufacturing, and quality. Assesses the choice of inactive ingredients (known as excipients) in a drug delivery system including its formulation and product design. Applies a risk and scientific-based approach to evaluate the adequacy of formulation studies to understand the impact of drug substance and excipient attributes on drug product performance. Evaluates the adequacy of control strategy (including quality standards) for drug substance and excipients. Establishes patient-centric quality standards for drug product to ensure its clinical performance. Evaluates the adequacy of the product usability and acceptability to the patient. Evaluates the adequacy of analytical procedures and controls as well as associated sampling plans for quality testing, monitoring, and control. Evaluates the adequacy of procedures and data to ensure the stability of the drug product during its labeled shelf life and assess the adequacy of the container closure system and proposed storage conditions for the commercial drug product. Evaluates manufacturing processes and facilities used by foreign and domestic manufacturers of drug products and assesses the adequacy of pharmaceutical manufacturing design and understanding, as well as process monitoring, control, and scale-up strategies. Participates in facility inspections related to the evaluation of manufacturing processes and controls and in support of preapproval and current good manufacturing practices (CGMP) inspections. Identifies and analyzes the role of the manufacturing process variables affecting pharmaceutical intermediates and finished products for various manufacturing processes (e.g., heating, drying, milling, mixing, filtration, coating, filling, compaction, perfusion, and/or sterile production) through scientific or engineered approaches (e.g., design of experiments, modeling and simulations, or multivariate analysis). Applies the scientific principles of International Conference on Harmonization (ICH) guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9), and Pharmaceutical Quality System (Q10) in the assessment of drug products, manufacturing, and control strategy, as well as in inspections, post-marketing, and surveillance activities. Evaluates the adequacy of analytical methods and validation reports used during synthesis, characterization, manufacturing, release and stability testing of drug substances and drug products. Evaluates the adequacy of sponsors data and results, including drug substance and drug product manufacturing, in-process, release (including real time release testing when available) and stability data, using appropriate quantitative or mathematical approaches or tools.