CMC Program Lead, Commercial Radiochemistry

This is a fully remote position, open to applicants in Canada, +2 more countries.

📋 Description

• Ensure the readiness of radiopharmaceutical assets for commercial launch and sustained viability in the market.

• Implement CMC strategies by collaborating with both internal and external stakeholders.

• Coordinate and execute CMC activities at radiochemical production partners for designated development programs.

• Strategize, plan, and deliver CMC initiatives, plans, and outputs from pivotal Phase 3 studies through to filing readiness, NDA/MAA/BLA submissions, and management throughout the commercial lifecycle.

• Act as the representative of the CMC team on global matrix teams.

• Facilitate, oversee, and lead internal CMC project teams across various functions including technical CMC, Supply Chain, Logistics, Validation, Quality, Clinical Operations, and Regulatory.

• Establish and maintain project dashboards, timelines, and budgets effectively.

• Monitor CMC deliverables and authorize invoices.

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

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

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

• Develop and maintain integrated project plans, interdependencies, and critical-path activities.

• Plan transitions from development to commercial operations and lifecycle management.

• Facilitate project meetings and support cross-functional decision-making processes.

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

• Identify gaps in processes and implement effective solutions.

⛳️ Requirements

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

• A minimum of 8 years of relevant experience in radiopharmaceutical, pharmaceutical, or biopharma CMC.

• At least 2 years of experience in CMC program or project management.

• Proven experience working with cross-functional teams, external partners, and CDMOs is required.

• Exceptional communication, collaboration, and change management skills are essential.

• Comprehensive knowledge of FDA and global regulatory requirements is necessary.

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

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

• Experience in successfully navigating a matrix-managed environment.

• Ability to show initiative, propose improvements, and establish new processes effectively.

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

• Willingness to travel 10–25% 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 professional learning and development.

• Competitive salary.