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

Job Title:CHEMIST, GS-1320-13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-MP-13-742335

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$89,033.00 to $115,742.00 / Per Year

OPEN PERIOD:

Thursday, October 04, 2012 to Friday, October 19, 2012

SERIES & GRADE:

GS-1320-13

POSITION INFORMATION:

Full Time - Permanent

DUTY LOCATIONS:

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

WHO MAY APPLY:

Status Candidates (Merit Promotion and VEOA Eligibles)

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.

Positions are located in the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of New Drug Quality Assessment.

 

As a Chemist you will be a part of a multi-disciplinary scientific and medical team that reviews, evaluates, and decides on the approvability of scientific submissions and applications that request FDA regulatory approval for clinical research, human safety testing, and manufacturing of human drugs.

 

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-DE-13-742334 under competitive procedures.  Please review that announcement to see if you are eligible for consideration under competitive procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement under noncompetitive merit promotion procedures. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

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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    • Reviews and evaluates scientific submissions to determine if the data submitted relating to product quality, based on the knowledge associated with chemistry, manufacturing, and controls (CMC) of drug products and substances, are adequate, well controlled, and sufficient to support the quality of the drug under investigation and those submitted for marketing approval.

    • Conducts risk assessments for New Drug Applications (NDAs), their supplements and Investigational New Drug Applications (INDs).

    • Assesses scientific submissions to ensure they are focused on critical quality attributes of the drug as they relate to product performance and its safety and effectiveness.

    • Determines suitability of drug product analytical methods for regulatory purposes or recommends other methods.

    • May be involved in developing policy, practices, and guidance related to the review of CMC information.


QUALIFICATIONS REQUIRED:

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Basic Qualification Requirement:

 

Degree: 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; OR a combination of education and experience -- course work equivalent to a major as shown 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 a copy of your transcript at time of application).

In addition to meeting the basic qualification requirement above, you must also have the following specialized experience:

GS-13:  At least one year of specialized experience (equivalent to the GS-12 level in the Federal service) that included assessing the quality and safety of human drug products; conducting analytical testing, development, or manufacturing of drugs; providing regulatory authority on chemistry and manufacturing controls (CMC) and/or pharmaceutical development and manufacturing; and interpreting and evaluating the results of analytical testing.


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.

Conditions of Employment:

 

1. Time-in-Grade: Career or career-conditional current and former Federal employees who select to apply under merit promotion procedures must have served 52 weeks at the next lower grade level of this position.

2.  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.

3. 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.

 

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

 

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

 

6. Financial disclosure statement may be required.

 

7. One-year probationary period may be required.

 

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

 

9. Bargaining Unit Position: Yes 

 

10. Drug Screening Required: No

 

11. Recruitment incentives may be authorized: No

 

12. Student loan repayment incentive authorized: Maybe

 

13. Annual leave for non-federal service authorized: Maybe

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.

For Competitive Merit Promotion and Veterans Employment Opportunities Act (VEOA) Applicants:  The highest rated candidates will be referred to the hiring agency.

For Noncompetitive Applicants:  All qualified candidates will be referred to the hiring agency.

The assessment questionnaire is designed to measure the following competencies that are required for this position:

  • Drug Research and Evaluation

  • Drug Regulation

  • Oral Communication

  • 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 Employment Opportunities Act (VEOA): To be eligible for a VEOA appointment, the veteran must 1) be a preference eligible; or 2) be a veteran separated after 3 or more years of continuous active service performed under honorable conditions (you must submit a DD214-member copy 4).

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:www.opm.gov/rif/employee_guides/career_transition.asp.

Noncompetitive Appointment Authorities:

The following links contain information on the eligibility requirements to be considered under a noncompetitive appointing authority:

http://www.opm.gov/hr_practitioners/lawsregulations/appointingauthorities/

Hiring Authorities for Veterans

People with Disabilities

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 742335.

 

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
  • Standard Form 50 (if you are a current or former Federal service employee)
    • College transcripts (to meet basic requirement)

      Other Supporting Documents: (Only submit if applicable to you.)
      • Veterans' documentation (i.e. SF-15, DD-214, Statement of Service, Service Connected Disability Letter, etc.)
      • CTAP/ICTAP documentation
      • PHS Commissioned Corps Officer documentation (i.e. cover letter indicating such status)
      • Noncompetitive appointing authority documentation

          APPLICATION MATERIALS MUST BE RECEIVED BY 11:59PM (EASTERN TIME) ON THE CLOSING DATE OF THIS ANNOUNCEMENT

        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-MP-13-742335

        Control Number:

        325981800