Service Coordinator coordinating HVAC service agreements, repairs, dispatch, and customer service for Trane Technologies. On - site in Burnaby, British Columbia.
About the role
- CMC Program Lead coordinating radiopharmaceutical manufacturing, regulatory readiness, and commercial lifecycle programs at Telix Pharmaceuticals. Leading cross-functional teams and CDMO/CMO partnerships for Illuccix and Gozellix.
Responsibilities
- 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
- 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
- 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
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