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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.
Job Responsibility:
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
Requirements:
Experience in commercial-scale GMP manufacturing (biologics drug substance)
Strong background in tech transfer and process validation
Hands-on experience with chromatography and filtration processes
Proven experience in cleaning validation and water mixing validation
Strong understanding of both manufacturing and quality perspectives
Experience in lab-to-commercial scale-up
Academic background: degree in engineering, life sciences, or related field
Fluent English. Additional languages are a plus.
You demonstrate strong problem-solving and stakeholder collaboration skills
Nice to have:
Additional languages are a plus.
What we offer:
An international community bringing together 110+ different nationalities
An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
A robust training system with our internal Academy and 250+ available modules
A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
Opportunity to turn your ideas into action and make a tangible impact
Empowered to design and lead projects that create real social or environmental impact, with the company’s full support