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
Experience in commercial‑scale GMP manufacturing (biologics drug substance)