Our organization is currently seeking a skilled Drug Product Specialist to join our team. This exciting opportunity will allow the successful candidate to demonstrate their technical expertise in drug product processes and contribute to the commercial manufacturing process.
About the Role:
* The Drug Product Specialist will provide support within the Drug Product manufacturing team, focusing on areas such as formulation, filling, lyophilisation, capping, and automated visual inspection.
* This individual will be responsible for process ownership and demonstrating technical excellence as a subject matter expert for drug product processes.
* The successful candidate will be involved in technical activities for commercial manufacturing processes, including authorship of change control documents, management of process improvement projects, statistical analysis of process performance,
* technology transfer activities, through authorship or review of required GMP documentation (Master Batch Records), regulatory filings;
* This role requires on-site coverage in support of Commercial and/or Technology Transfer Person-In-Plant Activities. The specialist must ensure that sites are inspection-ready for all routine inspections or related new product introductions/transfers with Operations Quality Regulatory teams engaged concurrently.
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Candidates Should Possess:
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