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*This announcement has been amended to extend the closing date and include additional cut-off dates.*
This announcement is open continuous till the closing date. Provided below are the following cut-off dates for certification:
- November 21st, 2013 - February 19, 2014
- December 21st, 2013 - March 21, 2014
- January 20th, 2014 - April 21, 2014
As a Chemist in the Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER), Office of Medical Products and Tobacco, Food and Drug Administration (FDA), you will evaluate drug substance synthesis, drug product formulation design, or drug product manufacturing processes and associated control strategies, including analytical procedures used to ensure the safety, efficacy and quality of drugs produced by foreign and domestic producers.
This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-14-977451 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.
- Reviews and evaluates chemistry, formulation, manufacturing, controls, and biopharmaceutics including drug releases, technical aspects of labeling and environmental impact information submitted in various drug applications and supplements (i.e., BLAs, NDAs, ANDAs, and INDs).
- Evaluates the adequacy of testing and control of container closure systems, starting and intermediate materials, reagents, and solvents.
- Establishes clinically relevant quality standards to ensure its clinical performance for approval to market and for the entire lifecycle of the drug product.
- Assesses the adequacy of pharmaceutical manufacturing; and, products usability and acceptability to the patient.
- Evaluates the adequacy of analytical methods and validation reports used during synthesis, characterization, manufacture, release and stability testing of drug substances and drug products.
- Communicates review outcomes including any identified deficiencies or issues, established policy and any further requests through oral and/or written communication.