JobMesh

Senior Scientist, CMC, Quality Control

City Therapeutics · Cambridge, Massachusetts, US

Senior Scientist, CMC Quality Control Job Summary City Therapeutics is seeking a passionate Senior Scientist, CMC Quality Control to join our growing team. T...

Job description

Senior Scientist, CMC Quality Control Job Summary: City Therapeutics is seeking a passionate Senior Scientist, CMC Quality Control to join our growing team. The current focus will be on release and stability management of oligonucleotide drug substances, drug products, and process intermediates (e.g., siRNA and conjugates). You will also lead method transfer and qualification to support internal labs and external partners. This role will report to the Senior Director, CMC AD/QC and contribute directly to City’s next-generation siRNA programs. Key Responsibilities: - Lead method verification/qualification, validation (as needed), and method transfer for existing and new programs. - Manage stability protocols and reports from partners - Conduct exploratory stability studies for raw materials, intermediates, DS, and DP; interpret trends and recommend actions. - Work both independently and with cross-functional teams to plan, prioritize, and meet project timelines. - Write CMC source documents such as, but not limited to, analytical methods, qualification/validation protocols and reports - Operate, calibrate, maintain, and troubleshoot analytical instrumentation; ensure adherence to da...