INTERDISCIPLINARY SCIENTIST, GS-12/13


Vacancy ID: 881071   Announcement Number: HHS-FDA-CDER-13-DE-881071   USAJOBS Control Number: 342327700

Social Security Number


Vacancy Identification Number

881071
1. Title of Job

Interdisciplinary Scientist
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 a discipline(s) you are interested in:

001 Biologist

002 Microbiologist

003 Pharmacologist

004 Chemist


001 Biologist
002 Microbiologist
003 Chemist

21. Geographic Availability


241450031 Silver Spring, 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. 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).
B. I possess a combination of education and experience -- Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education (must submit transcript at time of application submittal).
C. My education and/or experience are not reflected in choice A or B above.

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).
B. I possess a combination of education and experience -- courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above, plus appropriate experience or additional education (must submit transcript showing coursework at time of application submittal).
C. My education and/or experience are not reflected in choice A or B above.

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).
B. I possess 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 (must submit transcript showing coursework at time of application submittal).
C. My education and/or experience are not reflected in choice A or B above.

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)
B. My experience is not reflected in the description above.

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)
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.

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.