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.
  

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.

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