CHEMIST, GS-1320-12


Vacancy ID: 773690   Announcement Number: HHS-FDA-CDER-MP-13-773690   USAJOBS Control Number: 330119500

Occupational/Assessment Questions:

BASIC REQUIREMENTS

1. Please select one response from the choices below to show how you meet the Basic Requirements for Chemist position.

A. I meet the Basic Requirements for this Chemist position because I have a bachelors or higher degree in chemistry, 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. NOTE: To qualify using this alternative, you must submit a copy of your transcripts (official or unofficial) to verify your education. Otherwise, you will be found ineligible.

B. I do not have a bachelors degree as described above in response A, but I meet the Basic Requirements for this Chemist position because I have a combination of education and experience -- course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education, which together is comparable to a full 4-year course of study with a major in the appropriate field. NOTE: To qualify using this alternative, the contents of your resume must support this response and you must submit a copy of your transcripts (official or unofficial) to verify your education. Otherwise, you will be found ineligible.

C. I do not meet the complete requirements of either response A or B above and therefore do not meet the Basic Requirements for this Chemist position.

ADDITIONAL REQUIREMENTS

2. Please select one response from the choices below to show how you meet the Additional Requirements for this GS-1320-12Chemist position.

A. I qualify for this position at the GS-12 level because I have at least one year of full-time specialized experience equivalent to the GS-11 level in Federal service (obtained in the public or private sectors) that required me to: 1) review data to evaluate claims regarding the physical and chemical properties, analysis, efficacy, dosage and stability of proposed human drugs; 2) evaluate the adequacy of the analytical and manufacturing controls used in the manufacture of human drug products; 3) review the packaging, labeling of human drug products for accuracy and conformance with regulations; 4) prepare reports or letters explaining the conclusions of these analyses. NOTE: To be found qualified, the contents of your resume must support this response and show where and when you acquired this experience. Otherwise, you will be found ineligible.

B. I do not meet the complete requirements of response A above, and therefore do not qualify for this 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.
B- I have had education or training in how to perform this task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task; or I have supervised performance of this task or am normally an individual who is consulted by other workers to assist them in doing this task because of my expertise.

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.

A. Yes, I verify that, to the best of my knowledge and belief, all of the information included in this questionnaire is true, correct, and provided in good faith. I accept that if my supporting documentation and/or later steps in the selection process do not support one or more of my responses to the questionnaire that my rating may be lowered and/or I may be removed from further consideration.

B. No, I do not accept this agreement and/or I no longer wish to be considered for this position.