• Accountable to define and drive RM Trials in Lab/Industrial scale for external and internal solutions together with collaborators and COE DS Leaders to identify CMA & KMA of Raw Materials or to ensure double sourcing approach for RM. This would be done through design of experiments for specification range determination (process, product, and material attributes) in alignment with Quality by Design and Holistic Control Strategy Sanofi standards
• Accountable to lead DS RM Testing roadmap and its implementation in alignment with the RM double sourcing strategy roadmap of the Raw Material Program or to support Vendor Change Notifications (evaluation)
• Accountable to define testing strategy for double sourcing comparison of raw materials and demonstrate their interchangeability in the manufacturing process and ensure multiple sourcing approach for each single RM. Accountable to formalize Comparability demonstration of raw materials
• Accountable to master the material attributes including suppliers and CDMO practices until the use in process/product in relation with COE DS, Leaders, and COE Analytical Sciences through innovative approaches such as risk assessment, in process testing or final testing
• Accountable to develop technical exchanges with DS Leaders, suppliers, CDMO for developing knowledge on materials. Work with COE Analytical Sciences to ensure characterization for the identification of material attributes
• Contribute to define and develop suitable analytical methods for critical and key material attributes in relation with COE Analytical Sciences and Pillar 2 to have the Testing profile specifications supported by data testing material attribute variation impact on DS processes. For every Raw Material
• Support technical specification & URS, vendor evaluation, and selection while ensuring alignment with the drug substance timelines
• Accountable to define and drive innovative processes to create “one mRNA RM validation process” to support qualification of materials by WS 2 and be part of WS2 intelligence network and science-based approaches. Accountable to put in place all securing CMM methodologies and tools and for their updates driven by experiment

ABOUT YOU

This individual should have knowledge in traditional manufacturing processes of enzymes, nucleotides and cofactors, and analytical characterization.

Finally, the individual should have strong project leadership and interpersonal skills to engage and drive a collaborative and transversal working group across COE DS Process development & Industrialization and Analytical Sciences teams.

The individual should also understand Quality by Design and have an experience in Risk Assessments tools and Holistic Control Strategy principals.

Soft Skills

• Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communication
• Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support Sanofi’s scientific and business goals
• Highly organized, exceptional attention to detail, and strong proficiency in documentation skills
• Ability to prioritize and deliver on tight timelines
• Ability to work cross-functionally with other teams and stakeholders
• Be able to think strategically and lead teams/Strive for results

Technical Skills

• Understanding in manufacturing processes of enzymes, nucleotides and cofactors
• Understanding in mRNA manufacturing
• Strong and broad experience in Analytical Sciences (molecular biology, physico-chemistry, microbiology), Validation Models including design of experiments, statistical tools with raw materials and raw materials qualification principles
• Strong familiarity with cGMP and ICH Guidelines
• Experience in vendor evaluation, selection, and management is desired

Education

• Master’s degree or PhD degree in biochemistry

Languages

• French & English

Pursue progress, discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.