CMC Program Lead – Illuccix, Gozellix

This is a fully remote position, open to applicants in Canada, +1 more country.

📋 Description

• Develop, coordinate, and execute CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates from pivotal Phase 3 transition through filing readiness, NDA/MAA/BLA submissions, and commercial lifecycle management.

• Serve as a representative for the CMC team on global matrix teams for designated projects.

• Lead and facilitate internal CMC project teams encompassing technical CMC, Supply Chain, Logistics, Validation, Quality, Clinical Operations, and Regulatory functions.

• Create and uphold CMC project dashboards, timelines, and budgets.

• Monitor deliverables, initiate purchase-order requests, manage out-of-budget requests, approve invoices, and incorporate CMC plans into comprehensive project plans.

• Recognize CMC risks and develop mitigation strategies while communicating risks and issues to project teams and senior management.

• Provide updates to senior management regarding project status, timelines, risks, issues, KPIs, and forecasts.

• Oversee CDMO/CMO vendor selection and maintain relationships with contract manufacturing partners.

• Formulate and sustain integrated project plans with internal Telix teams and external CDMO/CMO partners.

• Coordinate transitions from development to commercial and lifecycle management.

• Facilitate team meetings utilizing project management best practices and tools.

• Maintain meeting agendas, minutes, decision logs, task lists, and risk analyses.

• Identify process gaps and implement effective solutions.

• Plan program and commercial budgets alongside Supply Chain, Program Management, and Finance.

• Manage change controls for intricate CMC activities, including regional launches, labeling modifications, and filing-related process enhancements.

⛳️ Requirements

• BA or BS degree in Business, Science, Mathematics, Engineering, or a related scientific field is required.

• Over 8 years of pertinent radiopharmaceutical/pharmaceutical/biopharma CMC experience.

• (Optional) A minimum of 2 years in CMC program/project management experience.

• Required experience collaborating with cross-functional teams, external partners, and CDMOs.

• Exceptional communication, collaboration, and change management abilities.

• Comprehensive knowledge of FDA and global regulatory standards.

• Strong technical comprehension of manufacturing, radiopharmaceuticals, and product/process development.

• Significant experience with MS Office suite applications and management software such as SAP, MS Project, and Smartsheet.

• Proven experience in a successful matrix-managed environment.

• Capacity to demonstrate initiative and enhance processes.

• Ability to excel in a dynamic, fast-paced, and continuously evolving global environment with minimal supervision.

• Willingness to travel 10–20% to manage collaborations with global team members and CDMOs.

🏝️ Benefits

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.

• Remote work arrangement available.

• Supportive and engaged colleagues.

• Global, interdisciplinary team environment.