CMC Program

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. 

See Yourself at Telix

As the CMC Program Lead covering Illuccix and Gozellix, you will play a critical role in ensuring successful readiness of the company’s radiopharmaceutical assets for ongoing commercial viability, market expansion, and process improvement.  Ensuring the effective execution of CMC strategies through the cross functional collaboration of internal and external partners.  The CMC Program Lead will be responsible for coordinating and delivering CMC activities at API, Fill/Finish, and Secondary Packaging partners in line with project requirements and company goals for assigned CMC development programs.  The CMC Program Lead will be the program matrix team representative for CMC and be responsible for driving activities across the CMC disciplines.

Key Accountabilities:

• Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates including a hand-off at pivotal Phase 3 studies through filing readiness, NDA/MAA/BLA submissions, and ultimately ongoing commercial life-cycle management
• Along with the CMC PL covering radioactive manufacturing, representing the CMC team on the global matrix team for the assigned projects
• 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, initiate PO requests, drive out of budget requests, 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 Procurement, Quality and CMC SMEs, and serve as the relationship lead to our internal and external contract manufacturing partners
• 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 program