Director, Commercial CMC Programs

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🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 10%

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• 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

🏖️ Benefits

• Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development • Competitive salaries