Global Manufacturing Engineer

🕒 il y a 16 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👷🏻‍♀️ Ingénieur

🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited

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

• Provide technical expertise for process development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging of small molecules and biologics • Analyze production processes and report results, identifying and communicating gaps, risks, and inefficiencies • Drive implementation of process improvements and risk mitigations • Lead manufacturing investigations and root cause analysis • Manage technical collaborations with multiple contract development/manufacturing organizations (CDMOs) • Author and review external manufacturing operation documents such as SOPs, batch records, protocols, and reports • Ensure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system

🎯 Exigences

• Science or engineering degree with 4+ years of relevant operational pharmaceutical experience across a breadth of functions including but not limited to, manufacturing operations, bioprocessing technology, validation, and engineering • Experience in MS Office suite applications (e.g., Excel, Word, Project) • Experience working with cross-functional teams, external partners and CDMOs • Experience in authoring challenging technical documents, including but not limited to, protocols, reports, CMC modules, and filing response • Strong experience in a key functional area within pharmaceutical operations • Experience in pharmaceutical and process development

🏖️ Avantages

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

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