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...