Chemist, GS-1320-13


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

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.