Tech Transfer Specialist

The Technical Operations team supports the client’s global manufacturing operations across both internal and external sites. The Technical Operations team delivers expert technical leadership, process ownership, and rapid solutions to ensure the delivery of the client’s product pipeline and technical leadership post-commercialisation.

This position requires effective cross-functional collaboration with external and internal partners, including Technical Services, Manufacturing Science & Technology (MS&T), Product Development and Clinical Supply (PDCS), Supply Relationship Management, External Manufacturing and Operations, Quality, and Regulatory partners.

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• Developing and implementing Technology Transfer (TT) Strategy, including Process Validation and Control Strategy. This includes drug substance and drug product (biologic) as well as drug product (e.g., oral solid dosage).
  
• Leading technical gap assessments and ensuring implementation of any associated mitigation activities.
  
• Authoring and reviewing project-related documentation, including reviewing, approving, and supporting protocols and reports.
  
• Ensuring site-specific Cleaning Validation and Media Fill Strategy (as applicable) is aligned with client global requirements.
  
• Providing SME input to technical aspects of IR response and supporting regulatory audits as needed.
  
• Supporting the implementation of TT and Validation best practices across the network, and working closely with other members of the TT and Validation team on the implementation of improvements.
  

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• 6 years’ experience providing technology transfer project support to drug substance or drug product manufacturing.
  
• Proven ability to successfully manage technology transfer programs at both site and corporate levels in support of GMP operations.
  
• Comprehensive understanding of technical and cGMP requirements for technology transfer activities.
  
• Ability to present and defend technology transfer topics during regulatory agency inspections.
  
• Experience in biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
  
• Extensive knowledge of regulations, current industry practices, and experience in the interpretation and application of guidelines and regulations.
  

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• Bachelor’s degree in Science or Engineering or a related field.
  
• Organized analytical thinker with strong attention to detail.
  
• Excellent oral and written communication skills, including technical writing. xcfaprz
  
• Ability to communicate technical and regulatory drivers with a proven capability of implementing technology transfer projects.