CMC Program Lead – Illuccix, Gozellix

This is a fully remote position, open to applicants in United States.

📋 Description

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

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

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

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

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

• Identify 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 the selection of CDMO/CMO vendors and manage relationships with contract manufacturing partners.

• Develop and sustain integrated project plans with internal Telix stakeholders and external CDMO/CMO partners.

• Organize hand-offs from development to commercial and lifecycle management.

• Lead team meetings employing project management best practices and tools.

• Maintain CMC communications, including agendas, minutes, decision logs, task lists, and risk assessments.

• Identify process deficiencies and implement effective solutions.

• Plan program and commercial budgets in coordination with Supply Chain, Program Management, and Finance.

• Manage change controls for intricate CMC activities, including expanded-region launches, labeling modifications, and process enhancements requiring filings.

⛳️ Requirements

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

• A minimum of 8 years of pertinent experience in radiopharmaceutical/pharmaceutical/biopharma CMC.

• At least 2 years of experience in CMC program/project management (optional).

• Proven experience collaborating with cross-functional teams, external partners, and CDMOs is essential.

• Exceptional communication, collaboration, and change management abilities.

• Comprehensive understanding of FDA and global regulatory standards.

• Solid technical knowledge of manufacturing, radiopharmaceuticals, and product/process development.

• Proficient in MS Office suite applications and management software such as SAP, MS Project, and Smartsheet.

• Experience in a successful matrix-managed environment.

• Demonstrated initiative to propose enhancements to existing systems and establish new processes.

• Ability to excel in a dynamic, fast-paced, and constantly 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 education and professional development.

• Competitive salary packages.

• Remote work options.

• Collaborative global, interdisciplinary team environment.