Sustainability Engineer

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Telix Pharmaceuticals Limited

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 2015

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• 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

🎯 Exigences

• 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

🏖️ Avantages

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