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Nucrogene Inc Formulation Scientist in Branchburg, New Jersey
Formulation Scientist (Branchburg, NJ)- Collaborate across teams, Analytical, Quality, and Regulatory functions to execute drug product formulation/process development, formulation strategies, control strategies, and support of drug application submissions and approval; lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysis to impact pipeline development and set strategic direction; as well as develop oral formulations for clinical studies and commercialization. Req’s Master’s deg. (or foreign equi. deg.) in Pharmacy, Chemistry or related with knowledge of clinical manufacturing & submissions following complete FDA guidelines; preparing regulatory submissions & performing critical review of technical documentation including product labeling, analytical procedures, specifications, batch records and other documents prior to FDA submission. Background check/drug screening required. Apply Nucrogene, Inc. 185 Industrial Parkway, Suite E, Branchburg, NJ-08876.