Scientist II; Analytical R&D
1 year ago
Hauppauge
Job DescriptionDescription: 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 provide technical support to other departments., • Effectively communicate information in concise reports., • Bachelor’s degree in chemistry or analytical chemistry with 4-5 years of pharmaceutical experience OR, • Instrumentation: HPLC, UPLC, ICP, GC, FT-IR, UV, Dissolution, pH, TOC and Karl Fischer., • Hours/Travel maybe subject to changed based on management/company discretion., • Work location are subject to change as needed to meet business requirements. $70,000 - $90,000 per year