This Position Is No Longer Available
  1. Overview
  2. Duties
  3. Qualifications & Evaluations
  4. Benefits & Other Info
  5. How to Apply

Job Title:Interdisciplinary Scientist, GS-405/601/660/1320-12/13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-DE-13-844652

This position is closed and no longer accepting online applications through USAJOBS.

The contents of the announcement can still be viewed.

SALARY RANGE:

$74,872.00 to $115,742.00 / Per Year

OPEN PERIOD:

Tuesday, March 19, 2013 to Tuesday, April 02, 2013

SERIES & GRADE:

GS-0405/0601/0660/1320-12/13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

Many vacancies in the following location:
Silver Spring, MD United StatesView Map

WHO MAY APPLY:

United States Citizens

JOB SUMMARY:

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

 

 

As a Chemist/Pharmacologist/Pharmacist/General Health Scientist in an Interdisciplinary position in the Office of Clinical Pharmacology, you will provide scientific expertise in the area of biopharmaceutics and pharmacokinetics. You will provide chemical, pharmacological, and regulatory expertise in the review and evaluation of request for the approval of clinical research, human testing, and the manufacture of human drugs.

 

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-13-844705

under merit promotion procedures.  Please review that announcement to see if you are eligible for consideration under merit promotion procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.

 

This job opportunity announcement may be used to fill additional vacancies.

 

KEY REQUIREMENTS

  • U.S Citizenship
  • Suitability for Federal employment determined by background investigation
  • May be required to serve a one-year probationary period

DUTIES:

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  • Provides scientific expertise in the area of biopharmaceutics and pharmacokinetics.

 

  • Reviews investigation new drug (IND)s, new drug applications (NDA) and Forms 5.

 

  • Recommends approval, disapproval, or new bioequivalence studies and/or protocols. Identifies potential bioequivalence problems and provides guidance for conducting bioequivalence studies.

 

  • Reviews and evaluates drug disposition data and specialized drug delivery systems to assure bioequivalence of drug products.


QUALIFICATIONS REQUIRED:

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Applicants must demonstrate that they meet the educational requirements (I) and the specialized experience (II) requirements as noted below:

I. Educational Requirements

A. Basic Educational Requirement for the GS-0405, Pharmacologist:

Possession of  a degree in an appropriate biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology. (Courses in chemistry, organic chemistry, biochemistry, general physiology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester hour requirement in chemistry and physiology. Courses in pharmacology, pharmacodynamics, pharmacotherapeutic, molecular pharmacology, and other similar subjects may be used to meet the 12-semester hour requirement in pharmacology. Courses dealing intensively with pharmacologically-oriented subjects may also be used to meet this requirement.) Transcript(s) must be submitted with application package prior to the closing date of the announcement.

B. Basic Educational Requirement for the GS-0601, General Health Science:

Possession of a four-year bachelor's degree related to the health sciences or allied sciences appropriate to the work of the position. Transcript(s) must be submitted with application package prior to the closing date of the announcement.

C. Basic Educational Requirement for the GS-0660, Pharmacist:

Possession of a four-year bachelor's degree in pharmacy from a program recognized by the American Council on Pharmaceutical Education AND possession of a license to practice Pharmacy in a State, territory of the United States, or the District of Columbia. You must provide a copy of your license and reference the details of your license in your resume. Transcript(s) must be submitted with application package prior to the closing date of the announcement.

D. Basic Educational Requirement for the GS-1320, Chemist:

Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in the 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. Transcript(s) must be submitted with application package prior to the close date of the announcement. OR Possession of a combination of education and experience. This includes 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. Transcript(s) must be submitted with application package prior to the closing date of the announcement.

II. Specialized Experience Requirements

A. In order to be qualified for this position at the GS-12 level, you must possess one year of specialized experience, equivalent to at least the GS-11 level in the Federal service performing scientific analyses in the area of biopharmaceutics and pharmacokinetics. Duties consisted of assisting in the review of a wide range of drugs received from the pharmaceutical industry to determine the adequacy of the bioequivalence protocols and resultant data from bioequivalence studies; assisting other scientists in performing tests and/or procedures that required using various methods and techniques; and modifying or adapting established protocols and procedures in response to test or study findings. Through experience, the applicant gained specialized knowledge of the chemical, pharmacology, biopharmaceutics and pharmacokinetic principles, theories, practices and technology involved in the research, development, and production of drugs for human use which enabled them to distinguish amongst the kind, quality, and adequacy of information and data submitted by the pharmaceutical industry.

B. In order to be qualified for this position for this position at the GS-13 level, you must possess one year of specialized experience, equivalent to at least the GS-12 level in the Federal service providing scientific expertise in the area of biopharmaceutics and pharmacokinetics. Duties consisted of reviewing a wide range of drugs received from the pharmaceutical industry to determine the adequacy of the bioequivalence protocols and resultant data from bioequivalence studies; performing complex tests and/or procedures that required using highly specialized methods and techniques; and modifying or adapting established protocols and procedures in response to test or study findings. Through experience,  the applicant gained a mastery of the chemical, pharmacology, biopharmaceutics and pharmacokinetic principles, theories, practices and technology involved in the research, development, and production of drugs for human use which enabled them to determine the kind, quality, and adequacy of information and data submitted by the pharmaceutical industry.


If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.  Degree requirements must be met within 30 days of the closing date of this job announcement and your  transcript(s) submitted must reflect this.

Failure to provide any of the above will result in an ineligible rating.  

Foreign Education:  If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program.  For further information, click on foreign education

All qualification requirements must be met by 11:59 PM (Eastern Time) on the closing date of this vacancy announcement.

1. Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees.  Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication.  Failure to successfully meet these requirements may be grounds for appropriate personnel action.  In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time.  Applicants are also advised that all information concerning qualifications is subject to investigation.  False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.

 

2. E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System.  Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system.  The U.S. Department of Health and Human Services is an E-Verify Participant.

 

3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.

 

4. All qualification requirements must be met by the closing date of the announcement.

 

5. Financial disclosure statement may be required.

 

6. One-year probationary period may be required.

 

7. Travel, transportation, and relocation expenses will be paid: No

 

8. Bargaining Unit Position: Yes   

 

9. Drug Screening Required:  No

 

10. Recruitment incentives may be authorized: No

  

11. Student loan repayment incentive authorized: No  

 

12. Annual leave for non-federal service authorized:  No

 

HOW YOU WILL BE EVALUATED:

Once the job opportunity announcement closes, a review of your résumé and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job.

 

If, after reviewing your résumé and supporting documentation, a determination is made that you have inflated your responses when compared to your background information, your score may be adjusted to more accurately reflect your skills and abilities.  Please follow all instructions carefully. Errors or omissions may affect your eligibility.

 

Qualified candidates will be assigned to the following quality categories:

 

Best Qualified - Meets the minimum qualification requirements and excels in most requirements of the position.

 

Well Qualified - Meets the minimum qualification requirements and meets most requirements of the position.

 

Qualified - Meet the minimum qualification requirements, but does not possess the relevant competencies to a substantive degree. 

 

The category assignment is a measure of the degree in which your background matches the required competencies listed below for this position.

  • Technical Competence in Clinical Pharmacology and Biopharmaceutics

  • Decision Making

  • Writing

  • Oral Communication

 

Application of Veterans' Preference:  Under Category Rating procedures, veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.

 

To preview the assessment questionnaire, click the following link:View Assessment Questions


BENEFITS:

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The Federal government offers a comprehensive benefits package.  Explore the major benefits offered to most Federal employees at http://www.opm.gov/retire/retire_jobseekers.asp.



OTHER INFORMATION:

Veterans' Preference: If you are a veteran claiming 5-point veterans' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement (including Character of Service) from your command if currently on active duty. If you are claiming 10-point veterans' preference, in addition to the DD-214, you must also submit a Standard Form 15 (Application for 10-Point Veteran Preference) and the required supporting documents listed on that form.  For more information on veterans' preference see www.fedshirevets.gov. 

 

Career Transition Program:  This program applies to Federal workers whose positions have been deemed 'surplus' or no longer needed, or an employee has been involuntarily separated from a Federal service position within the competitive service.  To receive selection priority for this position, you must be rated 'well-qualified.  Well-qualified means eligible applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements of the position.

For information on how to apply and what documents to submit as a CTAP/ICTAP eligible, go to: http://www.opm.gov/rif/employee_guides/career_transition.asp

Selective Service:  The Defense Authorization Act of 1986 requires that all male applicants born after 12/31/59 who are required to register under the Military Selective Service Act, be registered or they are not eligible for appointment to this position.  For further information concerning Selective Service requirements, please visit http://www.sss.gov/.



HOW TO APPLY:

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Click the Apply Online button to create an account or log in to your existing USAJOBS account.  Follow the prompts to complete the on-line assessment questionnaire. Please ensure you click the Submit My Answers button at the end of the process.

 

Note: To return to your saved application materials, log in at: https://applicationmanager.gov/ and click on 844652.

 

If you cannot apply online, you will need to:

1) Print the instructions and questionnaire by clicking View Occupational Questionnaire.

2) Print the 1203FX form to record your responses to the questionnaire.

3) Fax the completed 1203FX (all 6 pages but do not include a Cover Page for this document) to:  1-478-757-3144.

4) Print the Fax Cover Page and include with any supporting documents you fax (e.g., résumé, transcripts, veterans documentation, etc.) to the same fax number above.

 

Please do not complete steps 1-4 above if you are applying on-line.



REQUIRED DOCUMENTS:

  • Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed.
  • Responses to the Assessment Questionnaire

 

Other Supporting Documents: (Only submit if applicable to you.)

 

  • College transcripts (if qualifying all or in part based on your education)
  • Veterans' Preference documentation (i.e. SF-15, DD-214, Statement of Service, Service Connected Disability Letter, etc. ) 
  • CTAP/ICTAP documentation

 

APPLICATION MATERIALS MUST BE RECEIVED BY MIDNIGHT (EASTERN TIME) ON THE CLOSING DATE OF THIS ANNOUNCEMENT

 

For Résumé and Application Tips visit: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc

AGENCY CONTACT INFO:

Mid-Atlantic Services Branch
Phone: (757)441-6765
Email: NORFOLKMAIL@OPM.GOV
Agency Information:
HHS OPM
1900 E St NW
Washington, DC
20415

WHAT TO EXPECT NEXT:

You will be notified of your status when the list of candidates has been referred to the hiring manager for employment consideration.  


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Job Announcement Number:

HHS-FDA-CDER-DE-13-844652

Control Number:

338037400