Director overseeing commercial CMC programs for Telix, a radiopharmaceutical company developing targeted radiation products. Managing manufacturing, CDMO partnerships, supply chain, and clinical-to-commercial execution.
Responsibilities
Develop manufacturing and operational plans for commercial and late-stage clinical assets
Oversee a team of CMC program leads
Ensure execution of CMC strategies through cross-functional collaboration with internal and external partners
Coordinate and deliver CMC activities for Precision Medicine Diagnostics and Therapeutics programs
Establish global production, supply chain, logistics, and distribution supporting clinical-to-commercial progression
Partner with contract manufacturers and serve as liaison and escalation point for the External Contract Manufacturer network
Oversee manufacturing, quality, and product development from mid-stage clinical through commercial manufacturing
Manage contracts, budgets, cost savings, and capacity management
Sustain ECM strategy with Manufacturing Operations, Biologics, Radiochemistry, CMC Programs, Supply Chain, and Procurement
Coordinate internal and external communications and resolve business issues
Lead development and performance management of Commercial CMC Program Leads
Lead supplier performance business reviews
Create and populate ECM metrics scorecards and dashboards
Manage commercial manufacturing budgets and continuous improvement
Requirements
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 managing cross-functional teams, external partners, and CDMOs required
Experience managing cross-functional teams and International Contract Manufacturing Organizations
Ability to travel approximately 30% - both domestically and internationally
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
Strong communication, collaboration, adaptability, ethical behavior, and continuous learning capabilities
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