Main activities

• Develop Tech Transfer (TT) and validation strategies, taking best practices from the TT network into account and ensure alignment with relevant local and global stakeholders.
• Collaborate with CMOs to successfully execute manufacturing campaigns, implement process changes, and undergo inspections from health authorities.
• Develop and monitor the TT Plan, coordinating meetings with SMEs and CMOs, and escalating risks to stakeholders.
• Define the validation strategy in collaboration with Quality Project Leader and other stakeholders to ensure the timely execution of validation batches.
• Lead and coordinate technology transfer activities, from process design to regulatory approval with authorities.
• Develop project GARAMP risk profile and maintain throughout project and responsible for appropriate project risk management and stakeholder alignment throughout project execution.
• Conduct and implement comprehensive risk analyses, including Failure Mode and Effects Analysis (FMEA) specific to the insulin process, and implement robust mitigation plans at the Contract Manufacturing Organization (CMO).
• Accountable for the delivery (on time and in full) of all TT related works (i.e. process and analytical transfer) from process design to regulatory approval of the filing.
• Coordinate with QV Engineer in facility qualification activities and the preparation for regulatory inspections.
• Oversee with quality leader the implementation of the quality system for sterile projects (insulin and others), ensuring compliance with Sanofi and local regulatory requirements.
• Participate in engineering studies.
• Participate in the development and approval of URS, process equipment, qualification protocols and QC Lab.
• Ensure deployment of Analytical Methods Transfer with quality leader.
• Ensure the support of the FAT/SAT, installation, commissioning, and qualification of equipment at suppliers and receiving site Contract Manufacturing Organization (CMO) according to the need.
• 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 with Quality Leader.
• 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.
• Participate in the implementation of the quality system related to this activity.
• Ensure the preparation of prerequisites for validation batches and execute validation batches on time.

• 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.

Qualifications required for the position

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. 

Required training / 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 condition(s) (s) 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

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