Principal Associate Scientist, Analytical Sciences

Role: Principal Associate Scientist specializing in stability and analytical testing of siRNA drug substances, products, and raw materials. Objectives include supporting stability studies, analyzing data, and contributing to regulatory documentation. Responsibilities encompass designing and executing stability protocols, authoring reports and SOPs, evaluating stability data, and investigating out-of-trend results. The role also involves managing change controls, CAPAs, and providing expertise on temperature excursions. Qualifications: Master’s degree in Engineering, Chemistry, Pharmacy, Biochemistry, or related field plus 4 years’ experience, or Bachelor’s degree with 7 years’ experience. Must have hands-on experience with analytical techniques (HPLC, UPLC, spectroscopy), data review, statistical analysis, stability studies aligned with ICH guidelines, and cGMP environment. Preferred: experience with stability investigations, regulatory submissions, and technical writing. High-Value: focus on siRNA therapeutics, stability data interpretation, GMP compliance, and regulatory interaction; based at Cambridge, MA, with a 40-hour workweek. The position involves cross-functional collaboration within a biopharma setting, emphasizing analytical and stability expertise in RNAi therapeutic development.