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 is open until May 10, 2013. Applicants that apply on or before March 10, 2013 will be considered during the first cut off. Additional cutoffs will be used on the 10th of each month until the announcement closes.
The Generic Drug User Fee Act (GDUFA) is a collaboration between the Food and Drug Administration (FDA) and the pharmaceutical industry to help ensure that the United States generic drug system, both domestic and international, complies with the United States quality standards and increases the likelihood that American consumers get timely access to low cost, high quality generic drugs.
As a Chemist, you will be responsible for evaluating drug substance synthesis and manufacturing, drug product formulation and manufacturing, or drug substance and product quality control to ensure the safety and quality of generic drugs produced by foreign and domestic producers.
This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-13-840194 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.
Suitability for Federal employment determined by background investigation
May be required to serve a one-year probationary period DUTIES:
Evaluates the adequacy of generic drug industry methods used in, and the controls used for the design and manufacture of drug substances to establish and preserve their identity, quality, purity, and stability.
Evaluates the adequacy of generic drug industry methods used in, and the controls used for the design and manufacture of drug products to establish and preserve their identity, strength, quality, purity, and stability.
Evaluates the adequacy of generic drug industry methods and acceptance criteria of quality standards for drug substance and drug product.
Implementation with the abbreviated new drug applications or amendments and supplemental applications to ensure appropriate reporting of the chemical components, manufacturing, processing, packaging, control operations, stability, and the technical labeling.
Requests and prepares recommendations to the Office of Drug Manufacturing for manufacturing facility inspections to obtain further information on in the manufacturing and process controls used in the manufacture of the active ingredient and finished dosage forms described in the application and to verify the accuracy of the statements therein.
Serves as a technical expert and provides advice to other segments of FDA, other government agencies, and establishments outside the Federal Government on all matters pertaining to the Abbreviated New Drug Applications (ANDA's). QUALIFICATIONS REQUIRED:
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 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 demonstrating the required coursework noted above).
Specialized Experience Requirement:
GS-12 : Qualifying experience for the GS-12 includes one year of specialized experience (comparable to the GS-11 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 successfully the duties of the position. For this position, specialized experience is experience reviewing and analyzing the chemical processes and/or formulation involved in the manufacturing of drugs.
GS-13 : Qualifying experience for the GS-13 includes one year of specialized experience (comparable 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 successfully the duties of the position. For this position, specialized experience is experience leading the review and analysis of chemical processes and/or formulation involved in the manufacturing of drugs.
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. 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.
Designing and Manufacturing of Drug Substances/Products
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:
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/ .
usajobs.gov - 17 months ago
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