Read the statements below to determine what options (001 and 002) you are eligible to apply. You must enter at least one code.
001 - Merit Promotion: I am eligible to be considered under merit promotion procedures because I am a current FDA CDER employee working in a permanent competitive service position and meet Time in Grade requirements. (You must submit sufficient documentation to support your eligibility for Merit Promotion.)
002 - Noncompetitive: I am eligible to be considered under this specialty code because I am a current FDA CDER employee who currently holds or previously held a Federal position at the GS-13 or higher grade level (either in the competitive service or in another merit system with an interchange agreement), or who currently holds or previously held a GS-12 Federal position with promotion potential to the GS-13 or higher grade level (either in the competitive service or in another merit system with an interchange agreement). (You must submit sufficient documentation to support your eligibility for Noncompetitive Appointment).
1. Please select one response from the choices below to show how you meet the Basic Requirements for Chemist position.
2. Please select one response from the choices below to show how you meet the Additional Requirements for this GS-1320-12Chemist position.
KNOWLEDGE OF THE THEORIES, PRINCIPLES AND METHODS OF CHEMISTRY
For each task listed below, select the statement from A through E that best describes your level of experience, education, and/or training. If you leave any question blank your score will be negatively impacted. ATTENTION: For each question below, you must document your skill level in your resume. This means, for example, that if you rate yourself at the expert level (E) for a skill or task, you must document when you have supervised or trained others doing that skill or task. If you rate yourself at the independent level (D), you must show that you did the task as a regular and recurring part of a job. We will verify that you have documented your skills in your resume and your score will be lowered for skills that are not documented.A- I have not had education, training, or experience in performing this task.
3. Determine the active ingredients, excipients and finished dosage form of drug submissions.
4. Critically review data submitted regarding the physical and chemical properties, analysis and stability of human drugs.
5. Evaluate the correctness of the formulas and methods used in the synthesis, extraction, isolation or purification of new drug substances.
6. Evaluate the safety of inactive ingredients and the proper assembling and mixing of ingredients used in the manufacture of human drugs
7. Review and evaluate sections of abbreviated new drug applications, amendments and reports.
8. Review and evaluate drug sponsor's data and results to ensure accuracy and validity.
9. Review pharmaceutical developmental data and studies to support manufacture of human drugs using modern approaches including Quality by Design.
KNOWLEDGE OF THE FEDERAL FOOD, DRUG AND COSMETIC ACT, CFR AND OTHER GUIDELINES PERTAINING TO CHEMISTRY, MANUFACTURING AND CONTROLS IN THE PRODUCTION OF HUMAN DRUGS
10. Evaluate the adequacy of controls and testing of raw materials used in the development of human drugs.
11. Determine the adequacy of analytical controls used in the development of human drugs (including sampling controls and method validation activities.)
12. Interpret the laws and regulations pertaining to chemistry, manufacturing and controls pertaining to human drugs.
13. Review applications to ensure compliance with the laws and regulations pertaining to chemistry, manufacturing and controls involved in the production of human drugs.
14. Determine whether a submission is adequate to meet the requirements of applicable laws, regulations and guidelines.
ABILITY TO RECOGNIZE THE NEED FOR NEW APPROACHES TO SOLVE CRITICAL OR NOVEL PROBLEMS
15. Identify problems with chemical analyses for which there is no directly applicable regulation or guideline.
16. Research indirectly related information on chemical analyses to assist in determining a course of action to resolve technical issues that may be complex or novel.
17. Use judgment to determine areas of chemical analyses that need development and study and use ingenuity to devise and plan projects that investigate these areas.
18. Extend and adapt existing approaches and precedents to develop methods, specification and standards for similar and related drug products.
ABILITY TO COMMUNICATE ORALLY
19. Meet with representatives of the professional and academic communities and representatives of drug firms to exchange scientific information.
20. Meet with representatives of the professional and academic communities and representatives of drug firms to and provide advice and guidance regarding requirements of the law and regulations.
21. Meet with representatives of drug firms to explain why the firm's submissions fail to meet the FDA requirements and indicate what data or information should be supplied to complete the application.
22. Meet with representatives from private and Federal sectors to advise them on the application of Drug Efficacy Study Implementation, abbreviated new drug applications (ANDA) and amendments and supplemental applications regulations and guidance.
ABILITY TO COMMUNICATE EFFECTIVELY IN WRITING
23. Prepare comprehensive written evaluations showing the results of scientific reviews.
24. Prepare papers and reports to provide advice and information to other scientists.
25. Prepare responses to requests for guidance and information in response to the latest developments and changes in the area of human drugs.
26. Prepare questions to industry on potentially controversial topics such as findings of not approvable, inadequate, or incomplete.
27. Develop agency guidelines in response to the latest developments and changes in the area of human drugs and determine any further necessary revisions and additions to the guides.
CERTIFICATION OF INFORMATION ACCURACY
28. Your responses in this Assessment Questionnaire are subject to evaluation and verification. Later steps in the selection process are specifically designed to verify your responses. Deliberate attempts to falsify information may be grounds for disqualifying you or for dismissing you from employment following acceptance.
Please take this opportunity to review your responses to ensure their accuracy. By agreeing to the statement below, you are confirming that you have reviewed your responses to this questionnaire for accuracy, and verify that your responses accurately describe your current level of experience and capability.
Failure to agree to the statement below will disqualify you from further consideration for this position.