1. Please choose the best response that indicates that you meet the basic requirements for a Biologist position.A. I possess a degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position (must submit transcript at time of application submittal).
2. Please choose the best response that indicates that you meet the basic requirements for a Microbiologist position.A. I possess a degree in microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent (must submit transcript showing coursework at time of application submittal).
3. Please choose the best response that indicates that you meet the basic requirements for a Chemist position.A. I possess a 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 (must submit transcript showing coursework at time of application submittal).
4. Do you have one year of specialized experience, equivalent to the GS-11 level of responsibility in the Federal service that includes reviewing and evaluating drug applications, amendments, and supplements to ensure compliance with Current Good Manufacturing Practices (CGMPs); providing advice and guidance on policies and regulations regarding the manufacturing and distribution of new drug products; interpreting CGMP data of drug and/or biologic applications; and maintaining working relationships with regulated industry representatives and other sponsors?A. Yes (this specialized experience must be reflected in your resume)
5. Do you have one year of specialized experience, equivalent to the GS-12 level in the Federal service that includes leading the review and evaluation of drug applications, amendments, and supplements to ensure compliance with CGMPs; providing advice and guidance on policies and regulations regarding the manufacturing and distribution of drug products; recommending modifications, approval, or disapproval of new drug or related applications; and collaborating with regulated industry representatives and other sponsors to discuss and/or resolve manufacturing issues?A. Yes (your resume must reflect the specialized experience)
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.
6. Evaluate drug products as it relates to pharmaceutical manufacturing, scale-up testing, quality and/or regulatory affairs.
7. Recommend appropriate action to take on a drug application, supplement, and/or amendment.
8. Participate on inspections or inspection team to establish the preapproval or post approval of drug products.
9. Review applications, supplements and amendments of drug products to ensure compliance with regulations.
10. Prepare evaluations of inspection reports and manufacturing data submitted in support of Current Good Manufacturing Practices (CGMPs) and/or Biologics License Applications (BLAs).
11. Review and evaluate documents related to facility design and manufacturing operations, and controls to assure compliance with CGMPs.
12. Review scientific data to provide risk based decision on manufacturing procedures.
13. Provide advice in the interpretation of regulations and policy related to the manufacture and distribution of drug products.
14. Identify discrepancies or inconsistencies of manufacturers being inspected or investigated.
15. Meet with scientific, medical, and regulatory personnel to establish precedents and policies when policy is non-existent or applicable.
16. Present controversial scientific and/or regulatory issues to regulated industry, agency officials.
17. Discuss an organization's position on regulations, and/or regulated guidance documents.
18. Prepare reports that include the scientific findings relating to drug manufacturing.
19. Review manufacturer's responses to inquiries received from reviewing/investigating officials.
20. Write presentations of controversial scientific and/or regulatory issues for the office pertaining.