CMC Program Lead, Commercial Radiochemistry

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👻 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

• Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates from pivotal Phase 3 studies through filing readiness, NDA/MAA/BLA submissions, and commercial lifecycle management • Represent the CMC team on global matrix teams for assigned projects • Facilitate, manage, and lead internal CMC project teams across technical CMC, Supply Chain, Logistics, Validation, Quality, Clinical Operations, and Regulatory • Establish and maintain CMC project dashboards, timelines, and budgets • Track CMC deliverables and approve invoices • Ensure CMC strategies and plans are incorporated into overall project plans • Identify CMC risks and mitigation strategies and communicate risks and issues to project teams and senior management • Provide senior management with updates on project status, timelines, risks, issues, KPIs, and forecasts • Lead CDMO/CMO vendor selection with Procurement, Quality, and CMC SMEs • Serve as relationship lead for internal and external contract manufacturing partners • Develop and maintain integrated project plans and communicate interdependencies and critical-path activities • Plan hand-offs from development to commercial and lifecycle management • Facilitate team meetings using project-management best practices and tools • Maintain agendas, minutes, decision logs, task lists, and risk analyses/mitigation strategies • Identify process gaps and develop and implement solutions

🎯 Requirements

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline required • 8+ years of relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience • 2+ years of CMC program/project management experience • Experience working with cross-functional teams, external partners, and CDMOs required • Excellent communication, collaboration, and change management skills • Robust knowledge of FDA and global regulatory requirements • Strong technical understanding of manufacturing, radiopharmaceuticals, and product/process development • Strong experience with MS Office Suite and management software such as SAP, MS Project, and Smartsheet • Experience working in a successful matrix-managed environment • Ability to demonstrate initiative, suggest improvements, and establish new processes • Ability to thrive in a dynamic, fast-paced, continuously changing global environment with minimal oversight • Ability to travel 10–25% to manage collaborations with global team members and CDMOs

🏖️ Benefits

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