MSAT Tech Transfer Expert

Belgium, Verviers

MSAT Tech Transfer Expert is a Subject Matter Expert position. His expertise includes but is not limited to tech transfer, process validation, manufacturing technologies, manufacturing environment, analytical testing and product know-How. MSAT TT expert leads product/technology transfer projects from R&D/other Lonza sites/external partners to Verviers manufacturing facility.

  • Lead tech transfer projects. Ensure a proper communication between the sending party and the receiving site. Ensure that all tech transfer steps are followed per the effective tech transfer SOP.
  • This includes also when necessary execution of validation tasks. Ensure validation documentation is clear, scientifically based and in compliance with European GMP, ISO13485 expectations, 21CFR820.
  • This includes also supervising methodology transfer between sending party to the QC receiving department.
  • Provide exhaustive planning and accurate budget evaluation for projects
  • Lead technical investigations and support experiments for demonstration of potential root causes.
  • Provide support to other MSAT projects.
  • Keep up to date knowledge in manufacturing technologies and Science related to product

Skills

  • Proven experience in tech transfer process or in cell culture media/cell therapy/pharmaceutical product manufacturing
  • Experience in R&D/product development is an asset but not mandatory
  • Strong scientific knowledge in cell culture is an asset but not mandatory
  • High level of autonomy
  • Strong analytical and problem solving skills with pragmatic approach. Proven ability to perform investigations and use root cause analysis tools
  • Strong organizational skill. Ability to build accurate project planning and budget.
  • Good understanding of cGMP and validation principles
  • Strong knowledge of Microsoft Office software’s (Excel, PowerPoint, Word)
  • Basic statistical knowledge is mandatory
  • Advanced statistical knowledge is an asset
  • Fluent: French and english
  • Master degree Sciences, biotechnology, Chemistry or Biology
Reference: R42407