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, an...