CMC Program Lead, Commercial Radiochemistry

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

📋 Description

• Develop, coordinate, and implement CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates from critical Phase 3 studies through filing readiness, NDA/MAA/BLA submissions, and management of the commercial lifecycle.

• Act as a representative for the CMC team on global matrix teams concerning assigned projects.

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

• Create and uphold CMC project dashboards, timelines, and financial plans.

• Monitor CMC deliverables and authorize invoices.

• Ensure that CMC strategies and plans are integrated into the overall project frameworks.

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

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

• Lead the selection process for CDMO/CMO vendors in collaboration with Procurement, Quality, and CMC Subject Matter Experts (SMEs).

• Act as the primary relationship manager for both internal and external contract manufacturing partners.

• Develop and maintain comprehensive project plans while communicating interdependencies and critical-path activities.

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

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

• Keep records of agendas, minutes, decision logs, task lists, and risk analyses/mitigation strategies.

• Identify process deficiencies and create as well as implement effective solutions.

⛳️ Requirements

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

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

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

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

• Exceptional communication, collaboration, and change management abilities.

• In-depth knowledge of FDA and global regulatory standards.

• Strong technical expertise in manufacturing, radiopharmaceuticals, and product/process development.

• Extensive experience with MS Office Suite and management software such as SAP, MS Project, and Smartsheet.

• Experience in a successful matrix-managed environment is essential.

• Demonstrated ability to take initiative, propose enhancements, and establish new processes.

• 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 packages.