Interdisciplinary Scientist, GS-401-403-405-1320-13


Vacancy ID: 780473   Announcement Number: HHS-FDA-CDER-MP-13-780473   USAJOBS Control Number: 330433900

Social Security Number


Vacancy Identification Number

780473
1. Title of Job

Interdisciplinary Scientist, GS-401-403-405-13
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

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


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

Read the statements below to determine what options (01 and/or 02) you are eligible to apply.  You must enter at least one code.


01 Merit Promotion: 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.)
02 Noncompetitive: 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).

20. Occupational Specialties

Read the statements below to determine what options (001, 002, 003, and/or 004) you would like to be considered for.  You must enter at least one code.  Please ensure that you submit the proper documentation to support your answer (see required document section).

 


001 Biologist
002 Microbiologist
003 Pharmacology
004 Chemist

21. Geographic Availability


240130031 Bethesda, 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 the Biologist, GS-401-13.

A. Possess a four year 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. 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 the Microbiologist, GS-403-13.

A. Possess a four year 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 at time of application submittal).
B. 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 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 the Pharmacologist GS-0405-13.

A. Possess a four-year bachelor's degree in pharmacy recognized by the American Council on Pharmaceutical Education and be able to Applicants must be able to distinguish basic colors (must submit transcript at time of application submittal).
B. My education and/or experience are not reflected in choice A above.

4. Please choose the best response that indicates that you meet the basic requirements for the Chemist, GS-1320-13.

A. Possess a four year 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 at time of application submittal).
B. 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 at time of application submittal).
C. My education and/or experience are not reflected in choice A or B above.

5. Please choose the best response that indicates that you meet the specialized experience requirement for the Interdisciplinary Scientist position.

A. I have one year of specialized experience, equivalent to the GS-12 in the Federal service, that included analyzing and evaluating scientific and regulatory elements of Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs); and providing technical advice on complex regulatory and scientific research issues related to drug safety and efficacy; and drafting correspondence related to sponsors and manufacturers that demonstrate scientific and regulatory issues.
B. My experience is not reflected in choice A above.

Instructions: In this part, you will respond to questions about experiences you have had that are related to the requirements of the job for which you are applying. Carefully review the response descriptions listed below. For each question or statement, select the one response description that best describes your experience, education, or training.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing this 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 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.

6. Interpret data and develop new and novel solutions to respond to scientific and regulatory issues raised.

7. Reconcile varying opinions to develop the best evidence to support the standards established in drug policies.

8. Interpret and apply the Public Health Service Act and the Food, Drug, and Cosmetic Act and their implications to the regulation of protein therapeutic products.

9. Inspect drug manufacturing and testing facilities to determine if Good Manufacturing Practices were utilized.

10. Evaluate the safety and efficacy implications of changes to the chemistry, manufacturing, and control of monoclonal antibodies and antibody-related products.

11. Plan, review and facilitate mission-related research projects.>

12. Analyze data in the scientific fields of protein biochemistry including characterization (e.g. post translational modifications), and biopharmaceutical product development .

13. Serve as an expert in new technologies in modern biological sciences (e.g. surface plasmon resonance, mass spectrometry, capillary electrophoresis, particle analysis).

14. Prepare summarized findings and submit substantive scientific recommendations and conclusions.

15. Prepare proposed resolutions to establish policy regarding controversial and precedent setting drug issues.

16. Represent a program at national and/or international conferences.

17. Review regulatory submissions.

18. Solve complex regulatory and research issues by designing creative solutions that reflect a multidisciplinary approach to the program.

19. Evaluate and interpret current scientific literature and advancing research technology.