CMC Program Lead

🔥 0 minutes ago

🌐 United States, Belgium, +3 more countries – Remote

🇺🇸 United States – Remote 🇧🇪 Belgium – Remote 🇨🇦 Canada – Remote 🇨🇭 Switzerland – Remote 🇬🇧 United Kingdom – 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

• Lead the CMC Sub-Team and serve as the single point of contact for all CMC topics for the TLX597 and TLX66 program • Develop, execute, and maintain integrated CMC strategies and plans from preclinical development through Phase 3 • Coordinate functional SMEs across Drug Substance, Drug Product, Analytical Development, QC, QA, Supply Chain, Validation, and Regulatory CMC • Own CMC deliverables, timelines, budgets, risk registers, decision logs, project dashboards, and Gate-readiness packages • Track deliverables across concurrent targets and manage internal and external partner relationships, contracts, budgets, and invoices • Identify CMC risks, develop mitigation strategies, and escalate issues early • Provide regular CMC updates to senior management and program governance • Coordinate with manufacturing sites and external CDMOs/CMOs for Drug Substance and Drug Product supply • Partner with R&D, Discovery, Translational Development, Radiochemistry, Regulatory, Quality, Supply Chain, and collaboration partners • Support CMC IND packages, clinical supply workstreams, technology transfer packages, and phase-transition handoffs • Facilitate meetings and maintain agendas, minutes, decision logs, task lists, and risk analyses • Identify process gaps and implement solutions in accordance with 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 with biologics, monoclonal antibodies, bioconjugates, and/or radiopharmaceuticals required • Experience managing pharmaceutical alliance/partnership programs or multi-site CMC execution within a matrix operating model • Robust knowledge of FDA and global regulatory requirements, including IND and NDA/BLA requirements applicable to radiopharmaceuticals and biologics • Technical understanding of antibody manufacturing, upstream/downstream processing, bioconjugation, radiochemistry, and drug product fill/finish • Familiarity with ICH Q8-Q12 guidelines and Quality by Design principles, including TPPs, CQAs, CPPs, and control strategy development • Strong experience in project management across the drug development lifecycle • Experience working in a successful matrix-managed environment • Ability to demonstrate initiative and improve or establish processes • Ability to work in a dynamic, fast-paced, continuously changing global environment with minimal oversight • Ability to travel minimally 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 salary • Hybrid and remote work arrangements