CMC Program Lead

🕒 June 24

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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 first-in-human testing through later development phases, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions • Represent the CMC team on the global matrix team 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, approve invoices, and integrate CMC strategies and plans into overall project plans • Identify CMC risks and mitigation strategies, and communicate risks and issues to project teams and senior management • Provide regular updates to senior management on project status, timelines, risks, issues, KPIs, and future project needs • Lead CDMO/CMO CMC vendor selection and serve as a relationship lead • Develop and maintain integrated project plans with internal Telix teams and external CDMO/CMO partners • Develop global CMC program hand-offs from development to commercial and lifecycle management • Facilitate team meetings using project management best practices and tools • Organize CMC communications, including agendas, minutes, decision logs, task lists, and risk analyses/mitigation strategies • Identify process gaps and develop and implement solutions • Perform duties within established SOPs and applicable GxP requirements

🎯 Requirements

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline required • 10+ years of relevant radiopharmaceutical, pharmaceutical, or biopharma CMC experience • 5+ 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 applications and management software such as SAP, MS Project, and Smartsheet • Strong foundational collaboration skills 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 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 • Remote work arrangement