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Technology Transfer Leader
locationsRiyadh time typeFull time posted onPosted Today time left to applyEnd Date: December 13, 2024 (8 days left to apply) job requisition idR2774057
Job title: Technology Transfer Leader
Location Riyadh Job type: Permanent, Full time
About the job
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 country 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, cleaning validation, and the implementation of quality systems.
Main responsibilities:
Participate in engineering studies. Participate in the development and approval of URS, process equipment, qualification protocols and QC Lab Coordinates the transfer of analytical methods between the donor site and the receiving site. Coordinates the FAT, installation, commissioning, and qualification of equipment at suppliers and receiving site (Contract Manufacturing Organization) Coordinate and participate in the qualification activities of the facilities and the preparation of inspection visits to ensure the approval of SFDA authorities. Coordinates the implementation of the quality system of sterile projects (insulin and others) in accordance with Sanofi and country regulatory quality requirements. Participate in the management of project deviations, CAPAs and changes controls. Participates in the definition and execution of the Training program related to the products transfer. Ensure the effective delivery of the scheduled training and the assessment of employees' skill acquisition levels. Coordinates and participate in the adaptation of production and process procedures related to the project from Sending Unit to Receiving unit. Define the validation strategy with all stakeholders, prepare prerequisites and execute validation batches on time. Participate in the implementation of the quality system related to this activity and the training of employees. Ensure the preparation of prerequisites for validation batches. Coordinate with supply the provision of Packaging Items (ArtWork) related to this activity for validation purposes. Coordinates validation activities of new products in collaboration with all contributors (Engineering, Logistics, Quality, etc.) with the objective of Right First time and compliance with Planning. Manage and facilitate interface meetings between the Sending Unit, end users (CMO) and Sanofi group experts. Ensure the application of regulations during the project and health, safety and environmental rules. Apply and enforce HSE regulations and rules.
About you
Skills
Experience in pharmaceutical manufacturing, with at least 3 years in sterile production (e.g., injectable, biologics, vaccines, or other parenteral drug products). Experience in managing cross-functional teams in a complex, regulated environment. Familiar with product transfer programs Familiar with sterile injectable process equipment (aseptic preparation, aseptic filling line, sterilization, and defect inspection equipment, etc. Knowledge of pharmaceutical production processes and GMP requirements In-depth understanding of sterile production processes, such as aseptic filling, filtration, sterilization, and environmental control systems. Excellent communication skills, with the ability to present complex technical information to both technical and non-technical stakeholders. English level: Advanced.
Work experience:
Degree in Pharmaceutical Engineering, Chemical Engineering, Biotechnology, or a related scientific field. Minimum of 3 years’ experience in a similar position in a sterile injectable product manufacturing unit.
Special conditions of exercise:
Leadership ability to drive cross-functional teams and foster collaboration. High attention to detail and ability to prioritize multiple tasks in a fast-paced environment. Strong troubleshooting and analytical skills. High sense of organization and Planning
Pursue
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