CMC Program Lead, Commercial Radiochemistry
RemoteUnited Kingdom or Canada
Job Summary
Coordinate and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates, managing hand-offs from pivotal Phase 3 studies through filing readiness and NDA/MAA/BLA submissions. Lead internal CMC project teams comprising technical SMEs, Supply Chain, Logistics, Validation, Quality, Clinical Ops, and Regulatory while establishing project dashboards, timelines, and budgets. Facilitate CDMO/CMO vendor selection in collaboration with Procurement and Quality, and serve as the relationship lead for contract manufacturing partners. Proactively outline risks and mitigation strategies, communicate issues to senior management, and provide regular updates on project status, timelines, KPIs, and forecasting. Partner with Global Product and Brand Leads to develop integrated project plans and ensure smooth transitions from development to commercial lifecycle management. Travel 10-25% to manage collaborations with global team members and CDMOs.
Required Qualifications
- BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline
- 8+ years of relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience
- 2+ years of CMC program/project management experience
- Experience in 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 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 travel 10-25% to manage collaborations with global team members and CDMOs
Desired Qualifications
- Excellent communication, collaboration, and change management skills
- Ability to demonstrate initiative, suggest improvements to current systems as well as establish new processes
- Ability to thrive in a highly dynamic, fast paced, continuously changing global environment with minimal oversight/direction
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