Sustainability Engineer

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🕒 Maio 15

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👷🏻‍♀️ Engenheiro

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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

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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