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Sean McCarthy
Life Science

+3530212339371
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Details

Senior Tech Transfer Specialist


Reference:SMC37598 Location: Meath
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Technical Specialist

We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dunboyne. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

  • 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.

Education & Experience
  • 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 analyzing complex situations and showing practical problem-solving capabilities
  • 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

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.