Director, Commercial CMC Programs
RemoteCanada
Job Summary
Partner with contract manufacturers to create and maintain effective relationships, serving as the liaison and escalation point between Telix and the External Contract Manufacturer network. Provide oversight of manufacturing, quality, and development from mid-stage clinical through ongoing commercial production while managing contracts to ensure delivery and budget targets. Develop manufacturing and capacity strategies with Program leadership and Supply Chain to support global production, logistics, and distribution for late-stage and commercial assets. Lead a team of CMC program leads, conduct performance business reviews with suppliers, and establish key operating mechanisms for ECM oversight. Manage issues to ensure efficient business resolution and drive continuous improvement in commercial manufacturing budgets.
Required Qualifications
- BA or BS degree in Engineering, Biology, Chemistry, Business or other relevant field
- 10+ years combined experience in cGMP Manufacturing, Contract Manufacturing, Business Development, or Quality
- Experience in managing cross-functional teams, external partners, and CDMOs required
- Ability to travel approximately 30% - both domestically and internationally
Desired Qualifications
- Direct experience in Sterile Injectable Filling and Lyophilization of Drug Product/Substances supporting both pre-commercial and commercial products preferred
- Direct experience in Secondary Packaging of Parenteral drugs preferred
- Direct experience in complex formulations of bulk drug substances and biologic drug substance manufacturing preferred
- Experience managing cross-functional teams and International Contract Manufacturing Organizations
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