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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.
Job Description
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...