Scientist II; Analytical R&D

Job description

Description Position Summary: Develop stability-indicating methods. Design and conduct routine laboratory analysis using various analytical instruments and software such as HPLC, UPLC, ICP, and UV-Vis. Responsibilities: Responsibilities include, but are not limited to: - Knowledge of USP and FDA requirements. - Develop stability-indicating methods for Active Pharmaceutical Ingredients (API) and Dietary Supplement products. - Generate method validation protocols. - Execute methods validation and methods transfer. - Generate method validation reports and analytical methods. - Design and conduct full analysis of Dietary supplements and Active Pharmaceutical Ingredients (API) products and their impurities. - Conduct assay, content uniformity, dissolution, in-process blend, and blend uniformity of newly developed and stability samples in support of formulation and process development. - Prepare result documentation for department and general review. - Identify and resolve problems with analytical methods and provide troubleshooting on instrumentation. - Conduct Performance Qualification (PQ) on various instruments. - Provide leadership, guidance and hands-on training to new employee and...