Global CMC Program Lead, Radiopharmaceuticals

Telix Pharmaceuticals Limited; United States; Híbrido; USD 140.000 - 210.000; Jornada completa

Descripción de la vacante

Telix Pharmaceuticals Limited is seeking a CMC Program Lead to drive readiness and ongoing lifecycle management for radiopharmaceutical assets like Illuccix and Gozellix. You will coordinate CMC strategies across API, Fill/Finish, and packaging partners in a fast-paced, global environment.

The role requires deep CMC experience, strong collaboration with internal and external stakeholders, and a track record in matrix-managed settings, with travel 10–20%.

Formación

• BA or BS degree in Business, Science, Mathematics, Engineering, or a related scientific discipline is required.
• 8+ years of radiopharmaceutical/pharmaceutical/biopharma CMC experience, with optional 2+ years in CMC program/project management.
• Experience in working with cross-functional teams, external partners and CDMOs is required.
• Excellent communication, collaboration, and change management skills.
• Robust knowledge of FDA and global regulatory requirements; strong technical understanding of manufacturing, radiopharmaceuticals, and product/process development.
• Strong experience with MS Office and management software (e.g., SAP, MS Project, Smartsheet).
• Ability to thrive in a dynamic, matrix-managed environment and drive initiatives.

Responsabilidades

• Plan, coordinate, and deliver CMC strategies and deliverables across the program lifecycle, including filing readiness and NDA/MAA/BLA submissions.
• Represent CMC on the global matrix team and coordinate with radioactive manufacturing.
• Lead internal CMC teams with SMEs across Supply Chain, Validation, Quality, Regulatory, and Clinical Ops.
• Establish CMC dashboards, timelines, and budgets; track deliverables and manage budget requests.
• Identify CMC risks, communicate with senior management, and drive mitigation strategies.
• Lead CDMO/CMO CMC vendor selection and manage external partnerships.
• Develop integrated project plans with key Telix stakeholders to identify interdependencies and critical paths.

Conocimientos

Cross-functional collaboration

MS Office

Project management

Change management

Communication

Educación

BA/BS in science/engineering/business

Herramientas

SAP

MS Project

Smartsheet

Descripción del empleo

Telix Pharmaceuticals Limited is seeking a CMC Program Lead to drive readiness and ongoing lifecycle management for radiopharmaceutical assets like Illuccix and Gozellix. You will coordinate CMC strategies across API, Fill/Finish, and packaging partners in a fast-paced, global environment.

The role requires deep CMC experience, strong collaboration with internal and external stakeholders, and a track record in matrix-managed settings, with travel 10–20%.