CMC Program Lead – Illuccix, Gozellix

Telix Pharmaceuticals Limited

. Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates from pivotal Phase 3 hand-off through filing readiness, NDA/MAA/BLA submissions, and commercial lifecycle management .

Posted 10/2/2026full-timeRemote • Canada, United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC strategies and project management for radiopharmaceuticals, with a strong focus on regulatory compliance, cross-functional collaboration, and risk management. Proven ability to lead teams, manage vendor relationships, and drive process improvements in a dynamic environment.

Highest-signal resume keywords

Radiopharmaceutical CMC ExperienceFDA Regulatory KnowledgeCross-Functional Team CollaborationProject Management Software ProficiencyChange Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Strategy DevelopmentProject ManagementRisk AnalysisBudget ManagementManufacturing Process Development

Soft Skills

Excellent CommunicationCollaborationInitiativeProblem-SolvingAdaptability

Tools & Technologies

MS Office SuiteSAPMS ProjectSmartsheet

Industry Keywords

PharmaceuticalBiopharmaNDA SubmissionMAA SubmissionBLA Submission

About the role

Key responsibilities & impact

Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates from pivotal Phase 3 hand-off through filing readiness, NDA/MAA/BLA submissions, and commercial lifecycle management
Represent the CMC team on global matrix teams for assigned projects
Facilitate 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 deliverables, initiate purchase-order requests, manage out-of-budget requests, approve invoices, and integrate CMC plans into overall project plans
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 with internal Telix teams and external CDMO/CMO partners
Plan hand-offs from development to commercial and lifecycle management
Facilitate team meetings using project-management best practices and tools
Maintain meeting agendas, minutes, decision logs, task lists, and risk analyses
Identify process gaps and implement solutions
Plan program and commercial budgets with Supply Chain, Program Management, and Finance
Drive change controls for complex CMC activities, including regional launches, labeling changes, and filing-related process improvements

Requirements

What you’ll need

BA or BS degree in Business, Science, Mathematics, Engineering, or a related scientific discipline required
8+ years of relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience
(Optional) 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 and establish or improve processes
Ability to thrive in a dynamic, fast-paced, continuously changing global environment with minimal oversight
Ability to travel 10–20% 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
Remote work arrangement
Supportive and engaged colleagues
Global, interdisciplinary team environment