Chemistry Manufacturing & Controls (CMC) Manager

YOU WILL BE RESPONSIBLE FOR

• Manage external manufacturing and analytical activities at contract development and manufacturing organizations (CDMOs) to support commercial supply and clinical programs, ensuring collaboration, communication and scientific expertise.
• Manage GMP production of drug substance/drug product at CDMOs intended for nasal administration.
• Manage and support outsourced analytical development, validation and testing activities.
• Manage stability programs and trending.
• Provide technical expertise to support the development of new processes and formulations, scale‑up, technology transfer and validation.
• Review batch production records, certificate of analysis, stability reports, validation protocols and reports to ensure technical and cGMP compliance.
• Review and approve deviations, investigations, CAPAs and change controls as technical subject matter expert and make recommendations to Quali...