Technology Transfer Specialist

MeiraGTx

Shannon, County Clare, Ireland

Purpose of Job

To carry out Technology Transfer of new products from Process Development to Manufacturing (Plasmids and Viral Vectors).

To support the organisation and processes for project management and technical support in product lifecycle management activities including validation of manufacturing processes and methods in line with ICHQ8-10.

Major Activities
• Develop technical subject matter expertise in the technical support team and wider manufacturing operations.
• Project leadership/management and formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, launch and subsequent lifecycle management.
• Responsible for product lifecycle management activities including process validation of processes in line with ICHQ8-10.
• Lead and/or provide technical support using established problem solving techniques for investigations into quality events, customer complaints and IMC actions. Provide technical recommendations... More Detail

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