Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients

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

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

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