CMC Program Lead, Commercial Radiochemistry

Telix Pharmaceuticals Limited

CMC Program Lead advancing commercial radiopharmaceutical launches at Telix Pharmaceuticals. Coordinating manufacturing, regulatory readiness, CDMO partnerships, and lifecycle management for oncology and rare-disease products.

Posted 8/20/2026full-timeRemote • 🇨🇦 CanadaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC strategies and project management within the radiopharmaceutical industry, ensuring compliance with FDA and global regulatory requirements while effectively collaborating with cross-functional teams and external partners.

Highest-signal resume keywords

CMC Program/Project ManagementRadiopharmaceutical ManufacturingFDA Regulatory KnowledgeCross-Functional Team CollaborationMS Office Suite Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Strategy DevelopmentProject PlanningRisk ManagementBudget ManagementNDA/MAA/BLA SubmissionsProcess DevelopmentVendor ManagementTimeline TrackingQuality AssuranceData Analysis

Soft Skills

Excellent CommunicationCollaboration SkillsChange ManagementInitiativeProblem-Solving

Tools & Technologies

SAPMS ProjectSmartsheetProject DashboardsManagement Software

Industry Keywords

RadiopharmaceuticalsPharmaceuticalBiopharmaCommercial LaunchMatrix ManagementClinical OperationsSupply ChainValidationLifecycle ManagementCommercial Viability

About the role

Key responsibilities & impact

Ensure readiness of radiopharmaceutical assets for commercial launch and ongoing commercial viability
Execute CMC strategies through collaboration with internal and external partners
Coordinate and deliver CMC activities at radiochemical production partners for assigned development programs
Plan, coordinate, and deliver CMC strategies, plans, and deliverables from pivotal Phase 3 studies through filing readiness, NDA/MAA/BLA submissions, and commercial lifecycle management
Represent the CMC team on global matrix teams
Facilitate, manage, and lead internal CMC project teams across technical CMC, Supply Chain, Logistics, Validation, Quality, Clinical Operations, and Regulatory
Establish and maintain project dashboards, timelines, and budgets
Track CMC deliverables and approve invoices
Identify CMC risks and mitigation strategies and communicate risks and issues to project teams and senior management
Provide senior management updates on project status, timelines, risks, issues, KPIs, and forecasts
Lead CDMO/CMO vendor selection and manage relationships with contract manufacturing partners
Develop and maintain integrated project plans, interdependencies, and critical-path activities
Plan hand-offs from development to commercial and lifecycle management
Facilitate project meetings and cross-functional decision-making
Maintain agendas, minutes, decision logs, task lists, and risk analyses
Identify process gaps and implement solutions

Requirements

What you’ll need

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 applications 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/direction
Ability to travel 10–25% to manage collaborations with global team members and CDMOs

Benefits

Comp & perks

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