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About the Role
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...
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