Job Information
J-Star Research Research Scientist in Cranbury, New Jersey
1.Develop analytical methods to separate, detect, and analyze Active Pharmaceutical Ingredient (API), intermediates, impurities, starting material and excipients from drug substancesand drug products.2.Analyze organic and inorganic compounds to determine chemical or physical properties, composition, structure, relationships, reactions, using chromatography, spectroscopy,spectrophotometry techniques including HPLC, UPLC, IC, GC, MS, UV, XRPD, DSC, TGA, NMR, and KF.3.Design and perform method verification and validation. Determine the specificity, linearity, accuracy, precision, forced degradation, robustness of the methods.4.Collect and analyze data, and maintain data integrity under GMP, GLP, and FDA regulations. Prepare documentation of test procedures and technical reports.5.Prepare, review, and/or approve methods, protocols, and development reports.6.Maintain laboratory instruments to ensure proper working order. Apply scientific expertise to troubleshooting, laboratory investigation and problem resolution.7.Participate in maintaining high quality laboratory environment and comply with Health, Safety and Environmental responsibilities for the position.Requirements:1. Master in Chemistry, Chemical Engineering, Pharmaceutical Chemistry, or Food Science required;2, Must have at least one (1) year of experience in the pharmaceutical industry.3, Must have knowledge of FDA regulations, quantitative analysis, HPLC, UPLC, IC, and methodology development.