CMC Program Lead, Commercial Radiochemistry

Telix Pharmaceuticals Limited

CMC Program Lead advancing Telix’s radiopharmaceutical portfolio from late-stage development through commercial launch. Coordinating manufacturing, regulatory, and cross-functional CMC programs for precision medicine products.

Posted 8/20/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC strategies and project management for radiopharmaceuticals, ensuring compliance with FDA and global regulatory requirements while effectively leading cross-functional teams and managing vendor relationships.

Highest-signal resume keywords

CMC Project ManagementRadiopharmaceutical DevelopmentFDA Regulatory KnowledgeCross-Functional Team LeadershipMS Office Suite Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Strategy DevelopmentProject PlanningRisk ManagementBudget ManagementManufacturing Process UnderstandingProduct DevelopmentNDA/MAA/BLA SubmissionTimeline TrackingQuality AssuranceValidation Processes

Soft Skills

Excellent CommunicationCollaboration SkillsChange ManagementInitiativeProblem-Solving

Tools & Technologies

SAPMS ProjectSmartsheetProject Management Software

Industry Keywords

RadiopharmaceuticalsPharmaceuticalsBiopharmaCDMOMatrix ManagementLifecycle ManagementSupply ChainLogisticsClinical OperationsQuality Control

About the role

Key responsibilities & impact

Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates from pivotal Phase 3 studies through filing readiness, NDA/MAA/BLA submissions, and commercial lifecycle management
Represent the CMC team on global matrix teams 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 and approve invoices
Ensure CMC strategies and plans are incorporated into overall project plans
Identify CMC risks and mitigation strategies and communicate risks and issues to project teams and senior management
Provide senior management with updates on project status, timelines, risks, issues, KPIs, and forecasts
Lead CDMO/CMO vendor selection with Procurement, Quality, and CMC SMEs
Serve as relationship lead for internal and external contract manufacturing partners
Develop and maintain integrated project plans and communicate interdependencies and critical-path activities
Plan hand-offs from development to commercial and lifecycle management
Facilitate team meetings using project-management best practices and tools
Maintain agendas, minutes, decision logs, task lists, and risk analyses/mitigation strategies
Identify process gaps and develop 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 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
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 salaries