Job Title: Technical Operations Specialist
Job Summary:
We are seeking an experienced Technical Operations Specialist to support the manufacturing operations of drug products. This role will involve technical leadership, process improvements, and ensuring commercial processes operate to the highest standards.
Key Responsibilities:
* Provide day-to-day technical support across Drug Product operations including formulation, filling, lyophilisation, capping, and automated visual inspection.
* Serve as the process SME, taking ownership of assigned processes and demonstrating deep technical understanding and problem-solving capability.
* Lead and support technical activities for commercial manufacturing, such as writing change controls, managing process improvement initiatives, conducting statistical evaluation of process performance, and investigating atypical or non-conforming events.
* Contribute to technology transfer activities by preparing and/or reviewing GMP documentation such as master batch records, protocols qualification documents change controls reports regulatory submissions
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