This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/job/435819700. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
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Summary
This position is located in the Food & Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), in Silver Spring, Maryland.
This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-16-MP-1677817MH 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.
Who May Apply: Open to all United States Citizens.
Additional selections may be made within the same geographical area FDA-wide.
There
will be twelve cut-offs for this announcement. The first cut-off will be May 18, 2016. All applications received on or before this date will be
reviewed first.
Cut-off dates:
May 18, 2016
June 17, 2016
July 18, 2016
August 16, 2016
September 15, 2016
October 16, 2016
November 14, 2016
December 14, 2016
January 13, 2017
February 12, 2017
March 14, 2017
April 13, 2017
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Overview
- Reviewing applications
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Open & closing dates
04/18/2016 to 03/07/2017
-
Salary
$92,145 - $119,794 per year
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Pay scale & grade
GS 13
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Location
Many vacancies in the following location:
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Travel Required
Not required
-
Relocation expenses reimbursed
No
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Appointment type
Permanent
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Work schedule
Full-time - Full Time
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Service
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Promotion potential
13
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Job family (Series)
-
Supervisory status
No
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Announcement number
FDA-CDER-16-DE-1676693MH
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Control number
435819700
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Duties
As a Chemist, you will:
- Evaluate identification and characterization of drug substance's physical, chemical, biological and mechanical properties and their impact on the drug product;
- Evaluate manufacturing processes and facilities used by foreign and domestic manufacturers of drug substances and/or products;
- Apply mastery of chemistry principles, practices and procedures including Process Analytical Technology (PAT) to determine the adequacy of testing for raw materials and intermediates, the control of manufacturing processes, and the testing of the finished dosage forms;
- Participate in the facility inspections related to the evaluation of manufacturing processes and controls and in support of pre-approval and cGMP inspections.
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Requirements
Conditions of Employment
- U.S. Citizenship is required.
- One year probationary period may be required.
- Transcripts required.
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. Pre-employment physical required: No
5. Drug testing required: No
6. License required: No
7. Mobility agreement required: No
8. Immunization required: No
9. A background investigation may be required.
10. Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
11. Bargaining Unit Position: Yes
12. All qualification requirements must be met by the closing of the announcement.
13. Financial disclosure statement required: No
Qualifications
Basic Qualification Requirements for GS-1320, Chemist:
A. Possess and degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by coursework in mathematics through differential and integral calculus, and at least 6 semester hours of physics.
OR
B. Possess a combination of education and
experience--coursework equivalent to a major as shown in A above,
including at least 30 hours of chemistry, supplemented by coursework in
mathematics through differential and integral calculus, and at least 6
semester hours of physics, plus appropriate experience or additional
education.
In addition to the Basic Qualification Requirements you must also meet the following:
Have one year of specialized experience, equivalent to the GS-12 in the federal service. Such experience includes experience participating in the review and analysis of chemical processes and/or formulation involved in the manufacturing of drugs; analyzing and evaluating written scientific and technical data in order to review drug applications and their amendments/supplements; and identifying problems and deficiencies within drug manufacturing processes.Education
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. 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.
Additional information
If you are a veteran with preference eligibility and you are claiming 5-points veterans' preference, you must submit a copy of your DD-214 (Member 4 copy) or other proof of eligibility. If you are claiming 10-point veterans' preference, you must also submit an SF-15, "Application for 10-Point Veterans' Preference" plus the proof required by that form. For more information on veterans' preference see http://www.usajobs.gov/Veterans.
Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov).
For information on "People with Disabilities" please visit http://opm.gov/disability/PeopleWithDisabilities.asp
Career Transition Program: This program applies to Federal workers whose positions have been deemed "surplus" or no longer needed, or an employee who 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 an ICTAP eligible, see: http://www.opm.gov/rif/employee_guides/career_transition.asp
Candidates must meet time-after-competitive appointment, time-in-grade (if applicable), qualification requirements, licensure requirements, performance requirements, citizenship and suitability requirements, and any other eligibility requirements. All requirements must be met by the closing date of the announcement.
Benefits
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
The Federal Government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees at http://www.usajobs.gov/ResourceCenter/Index/Interactive/Benefits#icc.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
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 resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or 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.
Basis of Rating: Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be assigned to one of the following quality categories: Best Qualified, Well Qualified or Qualified.
The Category Rating Process does not add veterans’ preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA’s separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA’s.
1. Manufacturing of Drug Substances/Products
2. Analysis and Evaluation of Scientific and/or Technical Data
3. Communicating Scientific and/or Technical Data
Benefits
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
The Federal Government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees at http://www.usajobs.gov/ResourceCenter/Index/Interactive/Benefits#icc.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
Required Documents
As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you're a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you're eligible under their policies.
All applicants are required to submit the following supporting document type(s):
·Resume
Applicants may also submit the following supporting document type(s),which may not be required for all applicants:
·Cover Letter
·DD-214
·Other
·Other Veterans Document
·SF-15
·Transcript
Other Supporting Documents: (only submit if applicable)
- College transcripts (unofficial copy acceptable)
- Veterans’ Preference documentation [e.g., DD-214 which shows type of discharge/character of service (Copy 4), SF-15, VA letter, etc.]
- CTAP/ICTAP documentation
Faxing Applications or Supporting Documents:
You are encouraged to apply online. Applying online will allow you to review and track the status of your application.
NOTE: If you applied online and your application is complete, do not fax the paper application (1203FX) as this will overwrite your prior online responses and may result in you being found ineligible.
If you completed the occupational questionnaire online and are unable to upload supporting document(s):
1. To fax your documents, you must use the following cover page http://staffing.opm.gov/pdf/usascover.pdf and provide the required information. The Vacancy ID is 1676693.
2. Fax your documents to 1-478-757-3144.
If you cannot complete the Application Package online, you may fax all of your materials. The complete application package must be submitted by 11:59 PM (EST) on Tuesday, March 07, 2017 to receive consideration. Keep a copy of your fax confirmation in the event verification is needed.
To complete the occupational questionnaire and submit via fax:
1. Click the following link to view and print the occupational questionnaire View Occupational Questionnaire.
2. Print the 1203FX form, follow the instructions and provide your responses to the occupational questionnaire items http://www.opm.gov/forms/pdfimage/opm1203fx.pdf.
3. Fax the completed 1203FX form along with any supporting documents to 1-478-757-3144. Your 1203FX will serve as a cover page for your fax transmission.
4. This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@psc.gov. The decision on granting reasonable accommodation will be made on a case-by-case basis.
For Résumé and Application Tips visit: https://help.usajobs.gov/index.php/Tips.
If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
How to Apply
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 Tuesday, March 07, 2017 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 are submitted prior to the closing date.
- To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select 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.
- 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.
Agency contact information
FDA Helpdesk
- Address
-
HHS FDA Center
10903 New Hampshire Avenue
Silver Spring, MD 20993
Next steps
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We expect to make a selection within 45 days of the closing date of this announcement. Once this process is completed, you will be notified of your status via e-mail.
Fair and Transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
Help
·Cover Letter
·DD-214
·Other
·Other Veterans Document
·SF-15
·Transcript
Other Supporting Documents: (only submit if applicable)
Required Documents
All applicants are required to submit the following supporting document type(s):
·Resume
Applicants may also submit the following supporting document type(s),which may not be required for all applicants:
·Cover Letter
·DD-214
·Other
·Other Veterans Document
·SF-15
·Transcript
Other Supporting Documents: (only submit if applicable)
- College transcripts (unofficial copy acceptable)
- Veterans’ Preference documentation [e.g., DD-214 which shows type of discharge/character of service (Copy 4), SF-15, VA letter, etc.]
- CTAP/ICTAP documentation
Faxing Applications or Supporting Documents:
You are encouraged to apply online. Applying online will allow you to review and track the status of your application.
NOTE: If you applied online and your application is complete, do not fax the paper application (1203FX) as this will overwrite your prior online responses and may result in you being found ineligible.
If you completed the occupational questionnaire online and are unable to upload supporting document(s):
1. To fax your documents, you must use the following cover page http://staffing.opm.gov/pdf/usascover.pdf and provide the required information. The Vacancy ID is 1676693.
2. Fax your documents to 1-478-757-3144.
If you cannot complete the Application Package online, you may fax all of your materials. The complete application package must be submitted by 11:59 PM (EST) on Tuesday, March 07, 2017 to receive consideration. Keep a copy of your fax confirmation in the event verification is needed.
To complete the occupational questionnaire and submit via fax:
1. Click the following link to view and print the occupational questionnaire View Occupational Questionnaire.
2. Print the 1203FX form, follow the instructions and provide your responses to the occupational questionnaire items http://www.opm.gov/forms/pdfimage/opm1203fx.pdf.
3. Fax the completed 1203FX form along with any supporting documents to 1-478-757-3144. Your 1203FX will serve as a cover page for your fax transmission.
4. This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@psc.gov. The decision on granting reasonable accommodation will be made on a case-by-case basis.
For Résumé and Application Tips visit: https://help.usajobs.gov/index.php/Tips.
If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
Help
Learn more about this agency
How to Apply
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 Tuesday, March 07, 2017 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 are submitted prior to the closing date.
- To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select 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.
- 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.
Agency contact information
FDA Helpdesk
- Address
-
HHS FDA Center
10903 New Hampshire Avenue
Silver Spring, MD 20993
Next steps
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We expect to make a selection within 45 days of the closing date of this announcement. Once this process is completed, you will be notified of your status via e-mail.
Fair & Transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
Beginning of a dialog window for the agency announcing this job. It begins with a heading 2 called "Learn more about Field Operating Offices of the Office of the Secretary of the Army". Escape will cancel and close the window.
Learn more about
Food and Drug Administration
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.
Agency contact information
FDA Helpdesk
- Address
-
HHS FDA Center
10903 New Hampshire Avenue
Silver Spring, MD 20993