CMC Program Lead

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Play a critical role in ensuring successful development and manufacturing of radiopharmaceutical assets • Ensure effective execution of CMC strategies through collaboration of internal and external partners • Coordinate and deliver CMC activities in line with project requirements and company goals • Plan, coordinate, and deliver CMC strategies, plans, and deliverables for drug candidates • Represent the CMC team on the global matrix team for the assigned projects • Facilitate, manage, and lead internal CMC project teams • Establish and maintain CMC project dashboards, timelines, and budgets • Track CMC deliverables, approve invoices, and ensure CMC strategies are incorporated into overall project plans • Proactively outline CMC risks and mitigation strategies • Provide regular updates to senior management on project status, timelines, and risks • Lead CDMO/CMO vendor selection process in collaboration with Quality and SMEs • Partner closely with key stakeholders to develop integrated project plans • Develop global CMC program hand-offs to enable smooth transitions from development to commercial and lifecycle management • Facilitate team meetings using project management best practices/tools • Organize and maintain CMC team communications

🎯 Requirements

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline required • 10+ years of relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience with 5+ years of CMC program/project management experience • Experience in 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 in MS Office suite applications and management software (e.g., SAP, MS Project, Smartsheet) • Strong foundational collaboration skills with experience working in a successful matrix managed environment • Ability to demonstrate initiative, suggest improvements to current systems as well as establish new processes • Ability to travel to manage collaborations with global team members and CDMOs

🏖️ Benefits

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