Director, Commercial CMC Programs

🕒 August 20

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 30%

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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 effective 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 for clinical-to-commercial progression • Partner with contract manufacturers and serve as liaison and escalation point with the external contract manufacturer network • Oversee manufacturing, quality, and development from mid-stage clinical through ongoing commercial manufacturing • Manage contracts, budgets, cost savings, capacity management, and continuous improvement • Coordinate internal and external communications and resolve business issues • Lead development and performance management of Commercial CMC Program Leads • Lead supplier/contracting organization performance reviews • Create and manage ECM metrics, scorecards, and dashboards

🎯 Requirements

• BA or BS degree in Engineering, Biology, Chemistry, Business or another 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% domestically and internationally • Direct experience in Sterile Injectable Filling and Lyophilization of Drug Product/Substances supporting 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