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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 announcement is open continuous for 90 days with the following cut-off dates:
- February 23, 2014
- March 23, 2014
- April 23, 2014
This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-14-MP-1032985DG 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 FDA-wide to fill additional vacancies within the same geographical location.
- Review and evaluate 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).
- Evaluate the adequacy of testing and control of container closure systems, starting and intermediate materials, reagents, and solvents.
- Establish clinically relevant quality standards to ensure its clinical performance for approval to market and for the entire lifecycle of the drug product.
- Assess the adequacy of pharmaceutical manufacturing; and, products usability and acceptability to the patient.
- Evaluate the adequacy of analytical methods and validation reports used during synthesis, characterization, manufacture, release and stability testing of drug substances and drug products.
- Communicate review outcomes including any identified deficiencies or issues, established policy and any further requests through oral and/or written communication.