Job Description

Purpose of the assignment

Technology Transfer Leader coordinate and oversees the successful transfer of Insulins manufacturing technologies from the sending unit at Sanofi Frankfurt Site to the commercial production unit (Contract Manufacturing Organization, CMO). The Technology Transfer Leader will be responsible for managing the technology transfer process, ensuring the seamless integration of new manufacturing processes into production while maintaining the highest standards of quality and regulatory compliance, as well as adhering to project validation, batch, and commercialization timelines:

• Coordinate and manage the transfer of manufacturing technologies, processes, and analytical methods from Sending Unit to Receiving Unit (CMO)

• Coordinate and collaborate with cross-functional teams including, production, quality assurance, regulatory affairs, and supply chain to ensure smooth technology transfer.

• Coordinate and execute technology transfer plans, ensuring that all aspects of the transfer are well documented and meet all regulatory and quality standards.

• Ensure compliance with GMP (Good Manufacturing Practice), local contry regulation and other relevant pharmaceutical standards.

• Coordinate the training program for operational staff and stakeholders on new processes, technologies, and equipment.

• Ensure expertise in aseptic processes for sterile injectable products as part of the equipment acquisition process, process validation, MFT and cleaning validation,

• Support the implementation of quality systems on the project scope.

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