Technical Transfer Specialist

Summary:

Our Biotech client is looking to hire a permanent Technical Transfer Specialist to join their start-up facility. The role will project manage incoming product transfers and act as SME for the wider manufacturing team

Responsibilities

• 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, co-ordinate and execute CAPA's.
• Management of change controls; providing impact assessments as a technical functional, coordinating input and support from development if required. Lead/support and/or coordinate the action plans.

Requirements

• Scientific Degree or equivalent, preferably with a higher qualification in a discipline related to biopharmaceutical sciences.
• Extensive Fill & Finish experience in a commercial Pharma/Bio environment, ideally with exposure to automated visual inspection.
• Experience of transferring pharmaceutical products from Development into a GMP manufacturing environment, successfully gaining approval and launching new products commercially.

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