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Technical Transfer Specialist

Quality & Laboratory
Clare
Therese Keohane
Permanent
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Job Reference: JO-2103-65659_1615464176

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.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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