CMC Program Lead, Commercial Radiochemistry
Telix Pharmaceuticals Limited
August 20, 2026
Remote friendly (United States)
United States
Operations
Key Accountabilities
- Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates, including hand-off at pivotal Phase 3 through filing readiness, NDA/MAA/BLA submissions, and ongoing commercial life-cycle management
- Represent CMC on the global matrix team for assigned projects (along with the CMC PL covering non-radioactive manufacturing)
- Facilitate, manage, and lead internal CMC project teams (technical CMC SMEs, Supply Chain, Logistics, Validation, Quality, Clinical Ops, Regulatory)
- Establish and maintain CMC project dashboards, timelines, and budgets
- Track CMC deliverables, approve invoices, and ensure CMC plans are incorporated into overall project plans
- Outline CMC risks and mitigation strategies; communicate risks/issues to project teams and senior management
- Provide regular CMC updates on status, timelines, risks/issues, KPIs, and forecasting
- Lead CDMO/CMO CMC vendor selection in collaboration with Procurement and Quality; serve as relationship lead to contract manufacturing partners
- Partner to develop and maintain integrated project plans and identify/communicate interdependencies and critical path activities
- Plan hand-offs from development to commercial and lifecycle management
- Facilitate cross-functional meetings and communications (agendas, minutes, decision logs, task lists, risk analyses/mitigation)
- Identify process gaps and develop/implement solutions
Education and Experience / Requirements
- BA or BS in Science, Mathematics, Engineering, or related scientific discipline (required)
- 8+ years relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience, including 2+ years CMC program/project management experience
- Experience working with cross-functional teams, external partners, and CDMOs
- Robust knowledge of FDA and global regulatory requirements; strong technical understanding of manufacturing, radiopharmaceuticals, and product/process development
- Strong MS Office and management software experience (e.g., SAP, MS Project, Smartsheet)
- Ability to work in matrix environments; strong collaboration, initiative, and process improvement mindset
- Ability to travel 10–25%
Skills/Capabilities
- Excellent communication, collaboration, change management
- Results-oriented, creative/problem-solving, resilient, ethical, inclusive mindset, adaptability, continuous learning
- Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates, including hand-off at pivotal Phase 3 through filing readiness, NDA/MAA/BLA submissions, and ongoing commercial life-cycle management
- Represent CMC on the global matrix team for assigned projects (along with the CMC PL covering non-radioactive manufacturing)
- Facilitate, manage, and lead internal CMC project teams (technical CMC SMEs, Supply Chain, Logistics, Validation, Quality, Clinical Ops, Regulatory)
- Establish and maintain CMC project dashboards, timelines, and budgets
- Track CMC deliverables, approve invoices, and ensure CMC plans are incorporated into overall project plans
- Outline CMC risks and mitigation strategies; communicate risks/issues to project teams and senior management
- Provide regular CMC updates on status, timelines, risks/issues, KPIs, and forecasting
- Lead CDMO/CMO CMC vendor selection in collaboration with Procurement and Quality; serve as relationship lead to contract manufacturing partners
- Partner to develop and maintain integrated project plans and identify/communicate interdependencies and critical path activities
- Plan hand-offs from development to commercial and lifecycle management
- Facilitate cross-functional meetings and communications (agendas, minutes, decision logs, task lists, risk analyses/mitigation)
- Identify process gaps and develop/implement solutions
Education and Experience / Requirements
- BA or BS in Science, Mathematics, Engineering, or related scientific discipline (required)
- 8+ years relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience, including 2+ years CMC program/project management experience
- Experience working with cross-functional teams, external partners, and CDMOs
- Robust knowledge of FDA and global regulatory requirements; strong technical understanding of manufacturing, radiopharmaceuticals, and product/process development
- Strong MS Office and management software experience (e.g., SAP, MS Project, Smartsheet)
- Ability to work in matrix environments; strong collaboration, initiative, and process improvement mindset
- Ability to travel 10–25%
Skills/Capabilities
- Excellent communication, collaboration, change management
- Results-oriented, creative/problem-solving, resilient, ethical, inclusive mindset, adaptability, continuous learning