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-DE-14-977080

SALARY RANGE:

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

OPEN PERIOD:

Wednesday, October 23, 2013 to Monday, April 21, 2014

SERIES & GRADE:

GS-1320-13

POSITION INFORMATION:

Full Time - Permanent

DUTY LOCATIONS:

Many vacancies in the following location:
White Oak, MD View Map

WHO MAY APPLY:

United States Citizens

SECURITY CLEARANCE:

Not Applicable

SUPERVISORY STATUS:

No

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.

*This announcement has been amended to extend the closing date and include additional cut-off dates.*

This announcement is open continuous till the closing date. Provided below are the following cut-off dates for certification:

- November 21st, 2013   - February 19, 2014

- December 21st, 2013   - March 21, 2014

- January 20th, 2014      - April 21, 2014

As a Chemist in the Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER), Office of Medical Products and Tobacco, Food and Drug Administration (FDA), you will evaluate drug substance synthesis, drug product formulation design, or drug product manufacturing processes and associated control strategies, including analytical procedures used to ensure the safety, efficacy and quality of drugs produced by foreign and domestic producers.

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-14-977451 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.

TRAVEL REQUIRED

  • Not Required

RELOCATION AUTHORIZED

  • No

KEY REQUIREMENTS

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

DUTIES:

Back to top

  • Reviews and evaluates chemistry, formulation, manufacturing, controls, and biopharmaceutics including drug releases, technical aspects of labeling and environmental impact information submitted in various drug applications and supplements (i.e., BLAs, NDAs, ANDAs, and INDs).
  • Evaluates the adequacy of testing and control of container closure systems, starting and intermediate materials, reagents, and solvents.
  • Establishes clinically relevant quality standards to ensure its clinical performance for approval to market and for the entire lifecycle of the drug product.
  • Assesses the adequacy of pharmaceutical manufacturing; and, products usability and acceptability to the patient.
  • Evaluates the adequacy of analytical methods and validation reports used during synthesis, characterization, manufacture, release and stability testing of drug substances and drug products.
  • Communicates review outcomes including any identified deficiencies or issues, established policy and any further requests through oral and/or written communication.


QUALIFICATIONS REQUIRED:

Back to top

Applicants must demonstrate that they meet the basic AND the specialized requirement as noted below:

Basic Requirement: 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; OR a combination of education and experience -- course work equivalent to a major as indicated 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(s) at time of application demonstrating the required coursework noted above).

Specialized Experience Requirement:  

Qualifying experience for the GS-13 includes one year of specialized experience, equivalent in difficulty and complexity to GS-12 in the Federal service, which is directly related to the work of this position, and which has equipped the applicant with the knowledge, skills, and abilities to perform the duties of the position. For this position, specialized experience is experience leading the review and analysis of chemical processes and/or formulations involved in the manufacturing of drug substances and/or drugs; analyzing and evaluating written scientific and technical data in order to review drug applications or amendments; and communicating identified problems and deficiencies.


This position requires specific coursework and/or a degree to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.Your transcript(s) must clearly demonstrate the course(s) listed in the qualification requirement section. If the transcript(s) does not clearly demonstrate this you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. 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. 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 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 - Meets 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.
  • Manufacturing of Drugs
  • Analyze and Evaluate
  • Oral Communication
  • Written 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:

    Back to top

    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 http://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 more 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:

    Back to top
    To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below.

    The complete application package must be submitted by 11:59 PM (EST) on Monday, April 21, 2014 to receive consideration.

    * To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire.

    * Click the Submit My Answers button to submit your application package.

    * It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.

    To verify your application is complete, log into your USAJOBS account @ https://my.usajobs.gov/Account/Login and click the Application Status link and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application.  Your uploaded documents may take several hours to clear the virus scan process.

    To return to an incomplete application, log into your USAJOBS account @ https://my.usajobs.gov/Account/Login  and click Update Application in the vacancy announcement.  You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.

    To complete a hard copy assessment questionnaire and submit it via fax: Do not complete the steps below if you have already applied online to the questionnaire for this position.

    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

     



    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
    • College transcripts fully supporting the Basic Requirements

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

    • Veterans' Preference documentation (i.e., SF-15, DD-214, Statement of Service, Service Connected Disability Letter, etc. ) 
    • CTAP/ICTAP documentation

     

    If you are unable to upload supporting document(s) online, you can fax them by completing the following steps:

    1. Print out a Fax Cover Page @ http://staffing.opm.gov/pdf/usascover.pdf and complete the required information. The Vacancy ID is 977080

    2. Fax a Cover Page with each supporting document to 1-478-757-3144 by 11:59 PM (EST) on Monday, April 21, 2014 to receive consideration. Keep a copy of your fax confirmation in the event verification is needed.

     

    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.


    Back to top
    Dock
    Apply OnlinePrint PreviewSave JobShare Job

    Job Announcement Number:

    HHS-FDA-CDER-DE-14-977080

    Control Number:

    353335400