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

Job Title:Chemist

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-MP-13-874426

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$105,211.00 to $136,771.00 / Per Year

OPEN PERIOD:

Friday, April 26, 2013 to Friday, May 17, 2013

SERIES & GRADE:

GS-1320-14

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

14

DUTY LOCATIONS:

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

WHO MAY APPLY:

ONDQA Wide

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.

Who May Apply:  Federal employees with career or career-conditional appointments in the competitive service within the Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Science, Office of New Drug Quality Assessment employees only.

 

YOU MUST SUBMIT YOUR SF-50  

This position is located in at the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Science, Office of New Drug Quality Assessment.

  

This announcement may be used to fill multiple positions in multiple locations.

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Current SF-50
  • Current Resume

DUTIES:

Back to top

Major Duties:

 

Evaluates critical pharmaceutical quality attributes and their relevance to safety and efficacy and ensures consistency in new drugs quality assessments/chemistry reviews.

 

Ensures new drug product quality in line with quality-by-design (QbD) principles for New Drug Applications (NDAs), Investigational New Drug Applications (INDs) amendments and supplements.  

 

Assesses the pharmaceutical quality of new drug IND and NDA submissions by conducting critical quality reviews and identifying, communicating, and resolving approvability issues for IND and NDA assigned to the Division. 

 

Evaluates and formulates decisions or recommendations regarding approvability in accordance with applicable delegation of authority on the suitability of manufacturing methods and controls, drug products designs, and related facilities proposed by IND sponsors and NDA applicants.

 

Evaluates and assesses chemistry, manufacturing, and controls (CMC) specifications based on: risk-based assessments; clinical relevance (performance and safety considerations); process knowledge and understanding; and utilization of modern statistical methodologies.

 

Performs the initial screening, or triaging, of supplements and determines if/what type of ONDQA resources are needed to complete the quality review of supplements.

 

Assesses annual reports and evaluates the post-making reporting system.

 

Provides scientific expertise with an understanding of manufacturing processes and controls, as well as updated knowledge and skills in pharmaceutical dosage forms, process analytical techniques, and industrial pharmacy.

 

 



QUALIFICATIONS REQUIRED:

Back to top

Qualifications: 

For the GS-14 grade level, applicants must have 52 weeks in a non-temporary appointment at the GS-13 grade level in the Federal Service. 

 

Specialized experience:

Interfacing with multidisciplinary teams pertaining to New Drug Applications (NDAs) and Investigational New Drug Applications (INDs) involving the application of the Food, Drug and Cosmetic Act and other applicable rules and regulations for human drugs; performing timely, high quality Chemistry, Manufacturing and Controls (CMC) review of new molecular entities, complex formulations and manufacturing processes; independently resolving technical issues of exceptional complexity and scope; applying the principles, theories, and practices of chemistry, technology, quality and other concerns associated with manufacturing processes and controls involved in research, development, and production of drugs for human use; drawing scientifically sound conclusions from a wide array of publications and studies in order to make cogent recommendations; completing reviews of quality-by-design (QbD) based submissions (individually or as a team member); contributing to CMC reviewer training activities on emerging regulatory or scientific issues.   

 

Documenting experience:  In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description.  Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.


 

Conditions of Employment:

 

1. Additional Security and Background Requirements:  May be referred depending on the position being filled.  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. All qualification requirements must be met by the closing date of the announcement.

 

3. Financial disclosure statement may be required.

 

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

 

5. Bargaining Unit Position: Yes

 

6. Drug Screening Required: No

 

7. Recruitment Bonus may be authorized: No

 

8. Research position: No

 

9. Supervisory position: No

 

10. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.

HOW YOU WILL BE EVALUATED:

Once the application process is complete, a review of the resume 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 qualifications and/or experience, you may lose consideration for this position.  Please follow all instructions carefully.  Errors or omissions may affect your eligibility.

 

Your qualifications will be evaluated and rated on the following competencies (knowledge, skills, abilities and other characteristics):

 

Mastery of the theories, principles, and methods in the chemistry and associated scientific disciplines.

 

Knowledge and understanding of applicable laws, regulations, policies, procedures, standards and guidelines pertaining to human drugs.

 

Skill to identify problems, such as flawed studies or questionable results, and to recommend solutions.

 

Thorough knowledge and understanding of pharmaceutical dosage form development, process development, and manufacturing.

 

Ability to communicate in writing.

 

Ability to communicate orally.


BENEFITS:

Back to top

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.



OTHER INFORMATION:

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 Assistance Program (CTAP):  For information on how to apply as a CTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap.  To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.



HOW TO APPLY:

Back to top

How to Apply:

 

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

 

Note:  To return to a previously Saved or Incomplete application you may use the following link:  https://applicationmanager.gov.

 

To fax supporting documents you are unable to upload, complete this cover page http://staffing.opm.gov/pdf/usascover.pdf using the following Vacancy ID 874426.  Fax your documents to 1-478-757-3144.

 

If you cannot apply online:

  1. Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, and
  2. Print this 1203FX form to provide your response to the assessment questionnaire http://www.opm.gov/forms/pdf_fill/OPM1203fx.pdf and
  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 Center HelpDesk Telephone (888)-478-4340; TTY/TDD: (866)-539-4484; or by email quickquestions@psc.gov.  The decision on granting reasonable accomodation will be made on a case-by-case basis.


REQUIRED DOCUMENTS:

To apply for this position, you must provide a complete Application Package which includes:

 

1. Your Résumé

2. A complete Assessment Questionnaire

3. Other supporting documents:

- PHS Commissioned Corps Officer must submit a copy of latest personnel order

- SF-50 (if you are a federal employee or have reinstatement rights as a federal employee)

 

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

 

The complete Application Package must be submitted by 11:59 PM (EST) on Friday, May 17, 2013.

AGENCY CONTACT INFO:

FDA Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
HHS OHR
200 Independence Ave SW
HHH Building
Suite 801
Washington, DC
20201 Fax: (478)757-3144

WHAT TO EXPECT NEXT:

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.


You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed (generally 4-6 weeks).


Back to top
Dock
Print Preview

Job Announcement Number:

HHS-FDA-MP-13-874426

Control Number:

341517600