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Telix Pharmaceuticals Limited

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501 - 1000 Mitarbeiter

Gegründet 2015

🏥 Gesundheitswesen

💼 Beratung

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited ist ein biopharmazeutisches Unternehmen im kommerziellen Stadium, das sich der Transformation der Diagnose und Behandlung von Krebs und seltenen Krankheiten widmet. Mit einem Fokus auf die Entwicklung und Kommerzialisierung von theranostischen Radiopharmazeutika nutzt Telix zielgerichtete Strahlung, um die Entscheidungsfindung bei der Behandlung zu verbessern und personalisierte Therapien bereitzustellen. Mit einer umfangreichen Pipeline, die Bereiche wie Prostata- und Nierenkrebs, Neuro-Onkologie und muskuloskelettale Krebserkrankungen adressiert, hat Telix globale behördliche Zulassungen für seinen führenden Bildgebungsagenten Illuccix® erhalten und führt weltweit zahlreiche klinische Studien durch.

Beschreibung

• Technical lead of tech transfer and manufacturing activities related to drug substance and drug product formulation, radiolabeling, and fill/finish of small molecule and biologic based radiopharmaceuticals • Analyze production processes and report results. Identify and communicate gaps, risks, and inefficiencies. Drive implementation of process improvements and risk mitigations. Lead manufacturing investigations and root cause analyses • Support implementation of cold and hot analytical methods under the guidance of internal QC SMEs, ensuring alignment with approved methods, validation requirements, and quality standards. • Provide support to Regulatory Affairs for product IND and new NDA submissions, support inspection readiness, participate in regulatory agency inspections, and provide audit support, as required • Manage technical collaborations with multiple CDMOs to provide technical support and achieve key project milestones • Author and review documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial products • Ensure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system • Follows procedures to support intellectual property protection • Provide first line technical support for ongoing batch manufacturing as the first point of contact for technical questions, concerns, and/or escalations • Work closely and collaboratively with Quality Assurance to provide ongoing support to manufacturing partners

🎯 Anforderungen

• Bachelor’s or Master’s degree in science or engineering with > 7 years of experience in the radiopharmaceutical industry, including GMP; or PhD in science or engineering with >5 years of experience in radio-pharmaceutical or biopharmaceutical industry, including GMP • Hands‑on experience with multiple isotopes like F-18, Lu-177 and I-131 etc. • Demonstrated leadership and managerial skills • Experience working cross-functionally with a team of internal scientists and engineers, managing external CDMOs to ensure compliance with project timelines/cGMPs, and on-going manufacturing operations • Experience working in radiopharmaceutical manufacturing environments, including knowledge of radiation safety principles, ALARA, and applicable regulatory requirement • Experience in MS Office suite applications (e.g., Excel, Word, Project) • Experience in authoring challenging technical documents, including but not limited to, protocols, reports, SOPs, and quality investigations • Experience in radiopharmaceutical and process development

🏖️ Vorteile

• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development