CMC Program Lead

See Yourself at Telix

The CMC Program Lead is responsible for leading the CMC Sub-Team and serving as the single point of contact for all CMC topics on the program matrix for early-stage antibody-conjugate radiopharmaceutical diagnostic and therapeutic assets. The CMC Lead will develop, execute, and maintain the integrated CMC strategy and plan grounded in Quality by Design (QbD) principles, aligned to Stage-Gate requirements, spanning Drug Substance, Drug Product, Analytical Development, and Supply Chain from preclinical development through end of phase 1 (first-in-human). As the cross-functional integrator, the CMC Lead is the accountable owner for all CMC deliverables, establishing relationships with functional SMEs, internal manufacturing sites, and external partners to drive alignment, decision documentation, risk management, and Stage-Gate readiness. This position is part of the CMC Programs team within the Radiopharmaceutical Development group in Global Operations.

Key Accountabilities:

• Develop, own, and execute CMC strategies for antibody-based radiopharmaceutical drug candidates across the portfolio, from preclinical development through clinical supply. Apply QbD principles (target product profile, critical quality attributes, critical process parameters, control strategy) to drive science-based CMC development aligned to Stage-Gate expectations and readiness criteria
• Serve as the single point of accountability and key point of contact for all CMC matters within the program matrix. Lead the CMC Sub-Team and represent the CMC function within the broader program governance structure, ensuring all CMC questions, decisions, and deliverables are coordinated through a single accountable owner
• Lead the CMC Sub-Team for assigned programs, coordinating functional SMEs across Drug Substance (antibody/bioconjugate), Drug Product (radiochemistry/fill-finish), Analytical Development, QC, QA, Supply Chain, Validation, and Regulatory CMC across multiple Telix sites. In partnership with SMEs, own cross-functional integration and ensure CMC development activities are executed following QbD principles and sound scientific rationale
• Own and maintain the integrated CMC plan, risk register, decision log, and project dashboards for assigned programs, ensuring CMC timelines, budgets, and deliverables are traceable to Stage-Gate requirements
• Track CMC deliverables across multiple concurrent targets. Maintain relationships with internal and external partners, including contract management, budgeting, invoice approval, and ensuring CMC timelines are integrated with overall program plans and Gate-readiness milestones
• Proactively identify CMC risks and develop mitigation strategies. Escalate issues early, not when timelines are already at risk. Prepare Gate-readiness packages with documented evidence of deliverable completion, open risks, and residual risk rationale
• Provide regular CMC updates to senior management and program governance on project status, timelines, risks, Stage-Gate readiness, and resource forecasting
• Coordinate with internal manufacturing sites and external CDMOs/CMOs for Drug