CMC Program Lead

Summary

Join Telix Pharmaceuticals, a dynamic radiopharmaceutical company, as the CMC Program Lead and play a crucial role in the successful development and manufacturing of their radiopharmaceutical assets. You will be responsible for coordinating and delivering CMC activities for assigned development programs, ensuring alignment with project requirements and company goals. This role involves planning and executing CMC strategies, managing internal and external teams, establishing project dashboards and timelines, and proactively identifying and mitigating risks. You will also lead CDMO/CMO vendor selection, partner with key stakeholders, and develop global CMC program hand-offs for smooth transitions. The ideal candidate will have a strong background in radiopharmaceutical/pharmaceutical/biopharma CMC, experience in project management, and a deep understanding of FDA and global regulatory requirements.

Requirements

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline required
• 10+ years of relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience with 5+ years of CMC program/project management experience
• Experience in 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. Also possesses a strong technical understanding of manufacturing, radiopharmaceuticals, and product/process development
• Must have strong experience in MS Office suite applications and management software (e.g., SAP, MS Project, Smartsheet)
• Strong foundational collaboration skills with experience working in a successful matrix managed environment
• Ability to demonstrate initiative, suggest improvements to current systems as well as establish new processes
• Able to thrive in a highly dynamic, fast paced, continuously changing global environment with minimal oversight/direction
• Ability to travel to manage collaborations with global team members and CDMOs

Responsibilities

• Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates from first-in- human testing phases to all later phases of development, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions
• Represent the CMC team on the global matrix team for the assigned project/s
• Facilitate, manage, and lead internal CMC project teams comprised of technical CMC SMEs, Supply Chain, Logistics, Validation, Quality, Clinical Ops, and Regulatory
• Establish and maintain CMC project dashboards, timelines, and budgets for assigned projects
• Track CMC deliverables, approve invoices, and ensure the CMC strategies and plans are incorporated into the overall project plans
• Proactively outline CMC risks and mitigation strategies, and communicate risks and issues to project teams and senior management
• Provide regular CMC updates to senior management on project status, timelines, risks, issues, KPIs, and forecasting for future project needs
• Lead CDMO/CMO CMC vendor selection process in collaboration with Quality and CMC SMEs, and serve as a relationship lead
• Partner closely with all key stakeholders of the internal Telix teams, including Global Product Development Leads, Global Brand Leads, and external CDMO/CMOs to develop and maintain integrated project plans to identify/communicate interdependencies as well as critical path activities for the project
• Develop global CMC program hand-offs to enable smooth transitions from development to commercial and lifecycle management
• Facilitate team meetings using project management best practices/tools to drive cross-functional communication, timely and effective decision making, and successful execution of project objectives
• Organize and maintain CMC team communications including meeting agendas, minutes, decision logs, task lists, and risk analyses/mitigation strategies
• Identify gaps in processes, then work with appropriate parties to develop and implement solutions
• Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development