CHEMIST, GS-1320-12/13


Vacancy ID: 807391   Announcement Number: HHS-FDA-CDER-DE-13-807391   USAJOBS Control Number: 334090500

Social Security Number


Vacancy Identification Number

807391
1. Title of Job

CHEMIST, GS-1320-12/13
2. Biographic Data

3. E-Mail Address


4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

If you are applying by the OPM Form 1203-FX, leave this section blank.

6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade


12
13

11. Miscellaneous Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

If you are applying by the OPM Form 1203-FX, leave this section blank.

20. Occupational Specialties

Please choose: 001 All US Citizens


001 All U.S. Citizens

21. Geographic Availability


241360031 Rockville, MD

22. Transition Assistance Plan

23. Job Related Experience

If you are applying by the OPM Form 1203-FX, leave this section blank.

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. Occupational/Assessment Questions:

1. From the descriptions below, select the one which best describes your experience or education which meets the Basic Qualification Requirements for the Chemist, GS-1320.

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. (You must submit transcripts at time of application submission that demonstrates the required coursework noted above.)
B. I have a combination of education and experience that included 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. (You must submit transcripts at time of application submission that demonstrates the required coursework noted above.)
C. I do not have the education described above.

2. In addition to meeting the basic qualification requirements, you must meet the specialized experience requirements to qualify at the GS-12 level. From the descriptions below, select one response that best describes how your background meets the specialized experience requirements for a Chemist, GS-1320-12 position.

A. I possess one year of specialized experience equivalent to at least the GS-11 level in the Federal service. For this position, specialized experience is experience reviewing and analyzing the chemical processes and/or formulation involved in the manufacturing of human drugs.
B. I do not possess the specialized experience requirements as described above.

3. In addition to meeting the basic qualification requirements, you must meet the specialized experience requirements to qualify at the GS-13 level. From the descriptions below, select one response that best describes how your background meets the specialized experience requirements for a Chemist, GS-1320-13 position.

A. I possess one year of specialized experience equivalent to at least the GS-12 level in the Federal service. For this position, specialized experience is experience leading the review and analysis of chemical processes and/or formulation involved in the manufacturing of human drugs.
B. I do not possess the specialized experience requirements as described above.

For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing the 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. I have supervised performance of this task or am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

4. Evaluate the adequacy of drug industry methods used in, and the controls used for the manufacture of drug substances to establish and preserve their identity, quality, purity, and stability.

5. Evaluate the adequacy of generic drug industry methods and acceptance criteria of quality standards for drug substance and drug product.

6. Evaluate the adequacy of drug industry methods used in, and the controls used for the manufacture of drug products to establish and preserve their identity, strength, quality, purity, and stability.

7. Evaluate the correctness of formulas and the adequacy of manufacturing controls both in process and on the finished dosage form.

8. Evaluate the adequacy of packaging and storage procedures and the suitability of containers used in packaging the drug product for marketing.

9. Evaluate and incorporate the latest developments and changes into human drug quality assessment and safety guidelines and regulations.

10. Develop risk based approaches to the analysis and review of physical and chemical properties regarding the quality and stability of human drugs.

11. Prepare written evaluations showing results of scientific review.

12. Ensure appropriate reporting of the chemical components, manufacturing, processing, packaging, control operations, stability, and the technical labeling.

13. Prepare recommendations for manufacturing facility inspections to obtain further information on the process controls used in the manufacturing of the active ingredient and finished dosage forms described in the application.

14. Prepare validations of analyses, submitted as part of the applications or through literature search.