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Sean McCarthy
Life Science

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Details

Technology Transfer Specialist


Reference:SMC37595 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 execute the transfer requirements of both late stage clinical and/or PPQ (Process Performance Qualification) programs.
  • Attend meetings with local and international groups to coordinate and execute implementation tasks for new Drug Substance processes.
  • Manage new program introduction schedule to ensure tasks are executed on schedule and right-first-time.
  • Collaborate with stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
  • Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
  • Employ innovative and continuous improvement mindset to identify and implement opportunities to enable product launch.
  • Ensure the highest Quality, Compliance and Safety standards and embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
  • Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
  • Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.

Education & Experience
  • Minimum of 3 years of work experience in the pharmaceutical or biotech industry
  • Bachelor’s degree in Engineering, Biotechnology, Chemistry, or related field.
  • Technical knowledge with Biologics drug substance upstream and downstream operations or process development.
  • Understanding of the principles and activities of New Product Introduction NPI/Tech Transfer
  • Familiarity with the use of Automation systems in a manufacturing Process such as DeltaV, MES, eVal as well as business tools such as Power Project and Power BI.
  • Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.

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