CMC Program Lead – Illuccix, Gozellix

🕒 5 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

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Telix Pharmaceuticals Limited

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2015

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

A Telix Pharmaceuticals Limited é uma empresa biofarmacêutica em estágio comercial dedicada a transformar a forma como o câncer e doenças raras são diagnosticados e tratados. Com foco no desenvolvimento e comercialização de radiofármacos teranósticos, a Telix utiliza radiação direcionada para aprimorar a tomada de decisões terapêuticas e oferecer uma terapia personalizada. Com um extenso pipeline que aborda áreas como câncer de próstata e rim, neuro-oncologia e cânceres musculoesqueléticos, a Telix obteve aprovações regulatórias globais para seu principal agente de imagem, o Illuccix®, e está conduzindo ativamente inúmeros ensaios clínicos em todo o mundo.

Descrição

• Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates from pivotal Phase 3 hand-off through filing readiness, NDA/MAA/BLA submissions, and commercial lifecycle management • Represent the CMC team on the global matrix team for assigned projects • Facilitate, manage, and lead internal CMC project teams across technical CMC, Supply Chain, Logistics, Validation, Quality, Clinical Operations, and Regulatory • Establish and maintain CMC project dashboards, timelines, and budgets • Track deliverables, initiate purchase order requests, manage out-of-budget requests, approve invoices, and integrate CMC plans into overall project plans • Identify CMC risks and mitigation strategies and communicate risks and issues to project teams and senior management • Provide senior management updates on project status, timelines, risks, issues, KPIs, and forecasts • Lead CDMO/CMO vendor selection and manage relationships with contract manufacturing partners • Develop and maintain integrated project plans with internal Telix stakeholders and external CDMO/CMO partners • Plan hand-offs from development to commercial and lifecycle management • Facilitate team meetings using project management best practices and tools • Maintain CMC communications, including agendas, minutes, decision logs, task lists, and risk analyses • Identify process gaps and implement solutions • Plan program and commercial budgets with Supply Chain, Program Management, and Finance • Drive change controls for complex CMC activities, including expanded-region launches, labeling changes, and process improvements requiring filings

🎯 Requisitos

• BA or BS degree in Business, Science, Mathematics, Engineering, or a related scientific discipline required • 8+ years of relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience • 2+ years of CMC program/project management experience (optional) • Experience 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 • Strong technical understanding of manufacturing, radiopharmaceuticals, and product/process development • Strong experience with MS Office suite applications and management software such as SAP, MS Project, and Smartsheet • Experience working in a successful matrix-managed environment • Ability to demonstrate initiative, suggest improvements to current systems, and establish new processes • Ability to thrive in a highly dynamic, fast-paced, continuously changing global environment with minimal oversight/direction • Ability to travel 10–20% to manage collaborations with global team members and CDMOs

🏖️ Benefícios

• Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development • Competitive salaries • Remote work arrangement • Global, interdisciplinary team environment