Senior Manager, Analytical Chemistry

Role: Lead analytical chemistry activities supporting biopharmaceutical manufacturing at Rhythm, a company focused on rare neuroendocrine diseases. Responsibilities: oversee development, validation, and transfer of analytical methods for raw materials, excipients, in-process materials, and impurities; manage CRO/CMO collaborations; contribute to regulatory submissions; support deviation investigations and change controls; optimize analytical procedures for yield, purity, and impurity profiling. Requirements: Bachelor's (7+ years) or Master’s (5+ years) in analytical chemistry, pharmaceutical sciences, or related field; expertise in techniques like HPLC, GC, MS, and impurity analysis; experience with ICH, cGMP, and pharmaceutical quality standards; proven ability to author and review analytical validation and development documents. HighValue: pharmaceutical QC/CMC, analytical method validation, impurity qualification (including nitrosamines, extractables, leachables), biologic or small molecule manufacturing support, regulatory documentation. WorkSetup: hybrid Boston; some travel expected.