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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 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-DE-13-840268 under competitive procedures. Please review that announcement to see if you are eligible for consideration under competitive procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement under noncompetitive merit promotion procedures. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
This job opportunity announcement may be used to fill additional vacancies.
- 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).