Technology Transfer Specialist

Co. Meath
At the office
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An exciting opportunity has arisen for a Tech Transfer Sr. Specialist at our Biologics Innovation hub at Dunboyne. The Technology Transfer specialist will be a member of the Manufacturing team, reporting to the Technology Transfer Lead. The successful candidate would be a responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy. The Technology Transfer Specialist role will be a Change Champion within the organization and site, to bring about new products, digitization, and ways of working.

Primary Responsibilities

  • Collaborate with stakeholders to identify and execute the transfer requirements of programs. This may include late stage clinical and/or PPQ (Process Performance Qualification).
  • Lead tier meetings to coordinate activities between local and international groups for implementation of new Drug Substance manufacturing processes.
  • Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
  • Collaborate with stakeholders to deliver GMP documents related to TT, such as: Risk assessments, change controls, and process design documents.
  • Improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working, while remaining compliant with the Quality Manual.
  • Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, to progress the team forward to “one-click” tech transfer.
  • Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals.
  • Ensure the highest Quality, Compliance and Safety standards. 

Required Education, Experience and Skills

  • Minimum of 5 years of work experience in the pharmaceutical or biotech industry.    
  • Bachelor’s degree in: Biotechnology, Engineering, Chemistry, or related field. 
  • Experience with project management with cross-functional team members. 
  • Familiarity with upstream and/or downstream Unit Operations for mAb manufacturing.
  • Competent in analysing complex situations and showing practical problem-solving capabilities.

Preferred Experience and Skills

  • Minimum of 3 years of experience with quality management and compliance systems.
  • Understanding of the general principles of New Product Introduction (Tech Transfer).
  • Familiarity with the use of Automation systems in a manufacturing Process.
  • Competency in the use of automated/digital systems such as DeltaV, MES, eVal.
  • Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
  • Validation experience including validation documentation generation and execution.
  • Familiarity with risk assessment processes.

Important Dates
Posted on
09 July, 2024
Application deadline
24 July, 2024
Reference number

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