1. Select the option below that BEST describes your education to meet the basic qualification.A. I have a bachelor's degree in 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 of physics. (Must submit transcripts)
2. Do you have at least one year of specialized experience (equivalent to the GS-12 level in the Federal service) that included assessing the quality and safety of human drug products; conducting analytical testing, development, or manufacturing of drugs; providing regulatory authority on chemistry and manufacturing controls (CMC) and/or pharmaceutical development and manufacturing; and interpreting and evaluating the results of analytical testing?A. Yes, I have the experience described above.
For each of the items below, select the one statement that most accurately describes your experience and capability using the scale below.A- I have no experience in performing this work behavior.
3. Perform risk-based assessments of Chemistry, Manufacturing, and Controls (CMC) information used to manufacture drug substances and products.
4. Evaluate the adequacy of manufacturing facilities, synthesis processes, and in-process controls used to characterize and manufacture drug substances and products.
5. Identify critical quality attributes of drug products as they relate to drug product performance, safety, and effectiveness.
6. Develop chemical or physical assay methods and evaluate their validity and adequacy.
7. Apply knowledge of pharmaceutical dosage forms to their development including one or more of the following dosage forms: tablets, capsules, creams, lotions, solutions, transdermal patches, etc.
8. Apply drug labeling laws and regulations to drug product labeling.
9. Make recommendations regarding scientific and regulatory acceptability of proposed drug manufacturing, processes, and controls.
10. Attend conferences and technical meetings to exchange ideas with other scientists.
11. Present information and findings to internal and external customers, supervisors and senior level management at meetings.
12. Participate in the resolution of scientific disagreements through the development of acceptable compromises or suitable alternatives.
13. Respond verbally to complex questions and participate in integrated discussions regarding technical information and comprehensive summaries of conclusions and regulatory recommendations.
14. Communicate effectively with a variety of employees and other individuals working at all levels of management.