CMC Program Lead – Illuccix, Gozellix

🕒 il y a 24 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Telix Pharmaceuticals Limited

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 2015

🏥 Santé

💼 Conseil

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited est une entreprise biopharmaceutique en phase commerciale dédiée à transformer la manière dont les cancers et les maladies rares sont diagnostiqués et traités. En se concentrant sur le développement et la commercialisation de radiopharmaceutiques théranostiques, Telix utilise la radiation ciblée pour améliorer la prise de décisions thérapeutiques et fournir des thérapies personnalisées. Avec un vaste portefeuille dans des domaines tels que le cancer de la prostate et du rein, la neuro-oncologie et les cancers musculo-squelettiques, Telix a obtenu des approbations réglementaires mondiales pour son principal agent d'imagerie, Illuccix®, et mène activement de nombreux essais cliniques à travers le monde.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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