Job Description

ABOUT THE JOB

  • Support and execute technology transfer for drug substance manufacturing
  • Drive scale-up activities from lab to commercial production
  • Collaborate with cross-functional teams to ensure smooth implementation
  • Develop and optimize processes including purification, homogenisation, and cleaning processes for routine operations
  • Provide technical guidance to site teams
  • Lead and support validation activities including cleaning validation, water mixing validation, and risk assessments (e.g. extractables & leachables - E&L)
  • Ensure compliance with GMP and regulatory standards
  • Prepare and review validation protocols, reports, and technical documentation
  • Support integration of single-use systems and new manufacturing equipment

ABOUT YOU

  • Academic background: degree in engineering, life sciences, or related field
  • Experienc...

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