Developing theranostics (nuclear medicine) for prostate, kidney, glioblastoma, haematologic cancers and rare diseases.
Global Manufacturing Engineer
Location
United States
Posted
7 days ago
Salary
0
Seniority
Senior
Job Description
Global Manufacturing Engineer
Telix Pharmaceuticals Limited
• 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
Job Requirements
- 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
Benefits
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
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