Chemist, GS-1320-13


Vacancy ID: 977451   Announcement Number: HHS-FDA-CDER-MP-14-977451   USAJOBS Control Number: 353635200

Social Security Number


Vacancy Identification Number

977451
1. Title of Job

Chemist, GS-1320-13
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

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6. Citizenship

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

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8. Other Information

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9. Languages

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10. Lowest Grade


13

11. Miscellaneous Information

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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

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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

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 Competitive/VEOA eligibles:  I am eligible to be considered under merit promotion procedures because I am a current or former Federal employee working in a permanent competitive service position; or I am a veteran with preference; or I am a veteran who has been honorably discharged and substantially completed at least 3 years of continuous active duty service. (You must submit documentation to support your eligibility.)

002 - Noncompetitive Appointment eligibles: I am eligible to be considered under this specialty code because I meet the requirements for a noncompetitive appointment. Examples of non-competitive appointing authorities may include but not limited to: 30% or more compensable disabled veterans, Persons with Disabilities (Schedule A), PHS Commissioned Officer, Veterans’ Recruitment Appointment (VRA) [for positions up to the GS-11 Federal level], Peace Corps employees, current/former Federal employees who currently hold or previously held a Federal competitive position with promotion potential at or above the full performance level listed for this position, and a current Federal employee working in an excepted service position covered by an Interchange Agreement. (You must submit documentation to support your eligibility for noncompetitive appointment).

 


001 Merit Competitive
002 Noncompetitive

21. Geographic Availability


241679031 White Oak, 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.

If you selected responses A or B above, describe where on your transcript(s) can the course Differential and Integral Calculus be found. (Please provide in the space below the course title, title number (if applicable), dates taken, and school). Please note that you may be rated ineligible if this information is not provided as this is a requirement of the 1320 Chemist series.

2. Do you possess one year of specialized experience, equivalent in difficulty and complexity to at least the GS-12 level in the Federal service, leading the review and analysis of chemical processes and/or formulation involved in the manufacturing of drugs; analyzing and evaluating written scientific and technical data in order to review drug applications or amendments; and identifying chemical problems and deficiencies?

A. Yes
B. No

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.
B- I have limited experience in performing this work behavior. I have had exposure to this work behavior but would require additional guidance, instruction, or experience to perform it at a proficient level.
C- I have experience performing this work behavior across routine or predictable situations with minimal supervision or guidance.
D- I have performed this work behavior independently across a wide range of situations. I have assisted others in carrying out this work behavior. I seek guidance in carrying out this work behavior only in unusually complex situations.
E- I am considered an expert in carrying out this work behavior. I advise and instruct others in carrying out this work behavior on a regular basis. I am consulted by my colleagues and/or superiors to carry out this work behavior in unusually complex situations.

3. Develop and implement regulatory research policies and procedures designed to ensure product safety and quality.

4. Evaluate manufacturing processes and facilities used by foreign and/or domestic manufacturers of drug products.

5. Assess the adequacy of pharmaceutical manufacturing understanding as well as process control and scale-up proposals.

6. Participate in facility inspections related to evaluating manufacturing processes and controls in compliance with pre-approval and current Good Manufacturing Practices (cGMP) inspections.

7. Identify and characterize drug substances' physical, chemical, biological and mechanical properties, and their impact on a drug product.

8. Assess the choice of inactive ingredients (known as excipients) in a drug delivery system, including its formulation and product design.

9. Evaluate the adequacy of formulation studies to identify the impact of drug substance and excipient attributes on drug product performance.

10. Evaluate the adequacy of quality standards for drug substance and excipients.

11. Coordinate and provide interpretation and guidance on science and regulatory research and review which can cross organizational lines with an office.

12. Meet with stakeholders at various levels to solve discrepancies and problems incurring in the conduct of assignment.

13. Brief senior management on issues which include presenting ideas, findings, and recommendations.

14. Meet with other staff members and peers to discuss progress of work assignments and problems.

15. Prepare manuscripts covering any and all research, safety, and quality issues involving drug product manufacturing.

16. Evaluate reviews of New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Investigational New Drug (IND) regulatory submissions of chemistry pharmacological/toxicology, and clinical pharmacology.

17. Prepare technical responses to congressional inquiries and audit reports.

18. Prepare drafts, reviews, and/or recommendations for organization regulations.