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-12/13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-13-DE-881071

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:

Friday, May 31, 2013 to Friday, August 30, 2013

SERIES & GRADE:

GS-0401/0403/1320-12/13

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.

This Interdisciplinary Scientist position will be filled as one of the following disciplines: 0401 Biologist, 0403 Microbiologist, or 1320 Chemist.

 

This position is located in the Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). As an Interdisciplinary Scientist, you will be responsible for the evaluation of Current Good Manufacturing Practices (CGMPs) and/or drug applications and supplements associated with the manufacturing of human drug products.

This Job Opportunities Announcement will be open continuous for 90 days. The first cut-off date for applications received for consideration and/or referred to the hiring agency will be June 30, 2013. Subsequent referrals will be issued every 30 days until the announcement closes.

 

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-13-881057 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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  • Performs administrative and scientific regulatory review for Current Good Manufacturing Practices (CGMP) of products and facilities and/or with drug applications, supplements, and amendments.
  • Provides advice and guidance within assigned product area to manufacturers, consumers, investigators, other reviewers, and agency committees on CGMPs on process validation, environmental issues and/or facility design.
  • Evaluates facility design, operation, manufacturing and testing procedures to ensure compliance with CGMP regulations and policies. 
  • Meets with representatives of the regulated drug industry about potential product and establishment issues

    or scientific/regulatory issues involving drug products.


QUALIFICATIONS REQUIRED:

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Applicants must demonstrate that they meet any of the basic requirements (I, II, and/or III) AND the specialized experience requirement listed below:

 

I. Basic Requirements for Biologist: Possess a degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position; OR Possess a combination of education and experience -- Courses equivalent to a major, as shown above, plus appropriate experience or additional education (must submit transcript at time of application submittal).

 

II. Basic requirements for Microbiologist: 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; OR 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 above, plus appropriate experience or additional education (must submit transcript showing coursework at time of application submittal).

 

III. Basic Requirements for Chemist: 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; OR  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).

 

AND

 

Specialized Experience Requirements: 

GS-12: Applicants must 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.

 

GS-13: Applicants must 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.

 

 


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 submit documentation showing 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 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. 

 

  • Knowledge of drug manufacturing including biological, chemical or microbiological techniques.
  • Knowledge of Current Good Manufacturing Practices (CGMPs) regulations and related guidelines on drug manufacturing.
  • Communicate scientific and technical information orally.
  • Communicate scientific and technical information in writing.

 

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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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 Friday, August 30, 2013 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 (that reflect the required degree or coursework for the occupation/series you are applying for)

 

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 881071

2. Fax a Cover Page with each supporting document to 1-478-757-3144 by 11:59 PM (EST) on Friday, August 30, 2013to 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.  


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Job Announcement Number:

HHS-FDA-CDER-13-DE-881071

Control Number:

342327700