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).
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.
For positions with specific course requirements, you must provide documentation that clearly demonstrates the course(s) during the time of application submission. Failure to provide any of the above will result in an ineligible rating.
Conditions of Employment:
1. Time-in-Grade: Career or career-conditional current and former Federal employees who select to apply under merit promotion procedures must have served 52 weeks at the GS-13 or equivalent grade level.
2. 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.
3. 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.
4. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
5. All qualification requirements must be met by the closing date of the announcement.
6. Financial disclosure statement may be required: No
7. One-year probationary period may be required: Yes
8. Travel, transportation, and relocation expenses will be paid: No
9. Bargaining Unit Position: Yes
10. Drug Screening Required: No
11. Recruitment incentives may be authorized: No
12. Student loan repayment incentive authorized: No
13. 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.
For Merit Promotion Applicants: The highest rated candidates will be referred to the hiring agency.
For Noncompetitive Applicants: All qualified candidates will be referred to the hiring agency.
The assessment questionnaire is designed to measure the following competencies that are required for this position:
- Knowledge of drug manufacturing including Bbiological, chemical or microbiological techniques.
- Knowledge of Current Good Manufacturing Practices (CGMPs) regulations and related guidelines on drug manufacturing.
- Communicate scientific and technical drug information orally.
- Communicates scientific and technical information in writing.
To preview the assessment questionnaire, click the following link: TAG:Link to Questions Only