Job posting: CMC reviewer, FDA, Silver Spring, MD

Via the Chemistry Discord (deadline is April 12):

The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.

The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of pharmaceutical quality within CDER, including quality assessment of regulatory submission, manufacturing facility assessment, research, policy development, and surveillance of the quality of marketed pharmaceutical products.

The Offices of Product Quality Assessment (OPQA) III evaluate and assess product quality aspects over the product lifecycle for all types of human drug product applications, including Investigational New Drugs (INDs), Biologics Licensing Applications (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Active Pharmaceutical Ingredients (API) information supporting these applications, and make risk-informed recommendations on the approvability of such products and evaluates and assesses post-marketing activities for these drug products.

Duties/Responsibilities

As the Pharmaceutical Scientist, the incumbent is responsible for reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing (including process monitoring and controls), biopharmaceutics (including drug release), as well as technical aspects of labeling and environmental impact submitted in Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental BLAs, NDAs, as appropriate. 

Full ad here. Best wishes to those interested.