Head of Drug Product MSAT Synthetics Platform

Il y a 3 semaines

AmbarèsetLagrave, NA, France Sanofi Temps plein
*About Sanofi* We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives *About the job* Sanofi Global MSAT (Manufacturing Sciences, Analytics, and Technology) serves as the critical bridge between R&D and Manufacturing, ensuring supply continuity and enabling the successful launch of high-quality, innovative medicines. Global MSAT drives technical excellence across lifecycle management, process robustness, and performance optimization across Sanofi’s manufacturing network. Position Overview The Head of Drug Product – MSAT Synthetics Platform is a senior leadership role reporting to the Head of the Synthetics Platform. The role provides strategic, technical, and operational leadership for all Drug Product (DP) activities, including:
- Formulation & Process Development
- Engineering & Maintenance (DP-related systems and equipment)
- Quality & Compliance (DP scope) The incumbent will lead a multidisciplinary organization based in Ambarès, France, supporting a portfolio spanning late-stage development, launch readiness, and commercial products across the GenMed GBU. This role is accountable for end-to-end Drug Product performance within MSAT scope, from development through commercial manufacturing, across Sanofi’s internal sites and external partners. Main Responsibilities *Organizational Leadership & Team Development
*
- Lead, develop, and inspire a multidisciplinary Drug Product organization, fostering a high-performance, accountable, and collaborative culture
- Establish and inspire a cross
- site skill area network

- Define the organizational model, capabilities, and ways of working required to deliver on current and future portfolio needs.
- Provide technical leadership and mentorship to a diverse team with expertise in pharmaceutical formulation, process development, scale-up, and manufacturing support for synthetics drug products.
- Build and sustain strong leadership within the team, ensuring succession planning and talent pipeline development
- Contribute to the Synthetics Platform's effectiveness through active participation in Global MSAT, M&S GenMed, R&D CMC Development, Industrial Product Teams, and Drug Product Manufacturing Site governance forums *Drug Product Innovation & Lifecycle Management
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- Define and execute the global DP strategy for the synthetic product portfolio across launch, and commercialization
- Ensure robust, compliant, and efficient formulation and process development for OSD, semi-solids, liquids, and emerging formats
- Drive platformization, standardization, and harmonization of DP processes, formulations, and control strategies across the network
- Lead lifecycle management (LCM), including post-approval changes, cost optimization, and process improvements
- Ensure all DP activities meet global regulatory expectations (ICH, FDA, EMA, etc.) *Commercial Manufacturing Support
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- Provide end-to-end oversight of technology transfer, validation, and commercial manufacturing support for DP processes
- Ensure robust control strategies for Critical Quality Attributes (CQAs) and process performance across the lifecycle
- Lead complex troubleshooting, root cause investigations, and technical decision-making at product and network level
- Drive continuous improvement in yield, reliability, compliance, and cost efficiency
- Ensure strong integration with MSAT transversal teams, sites, and CMOs *Innovation & Digital Transformation
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- Drive innovation in formulation science, process technologies, and manufacturing approaches, including: Continuous Manufacturing, Advanced Characterization , Process Analytical Technology (PAT)
- Lead implementation of digital solutions for DP development and manufacturing: Data-driven process monitoring, Digital twins / modeling (where applicable), data integrity and analytics frameworks
- Build external partnerships (academia, industry) to strengthen scientific and technological leadership *Strategic Leadership & Vision
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- Define and articulate a clear vision and ambition for Drug Product within the Synthetics Platform
- Influence enterprise-level decisions as a trusted technical and business leader
- Contribute to the broader MSAT and M&S strategy, including operating model evolution
- Drive cross-functional alignment across R&D, Manufacturing, Quality, Regulatory, and Digital
- Champion change management and transformation in a complex, global environment *Key Challenges
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- Managing a complex and multidisciplinary DP organization in a transforming operating model
- Driving harmonization and standardization across legacy processes and sites
- Delivering innovation within resource and regulatory constraints
- Leading through significant organizational and cultural change
- Navigating a highly matrixed stakeholder environment About You Basic Qualifications
- Ph.
D. or advanced degree
in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related field
- ~12+ years of experience in the pharmaceutical industry, including senior leadership roles
- Strong expertise in drug product development and manufacturing (formulation, process development, scale-up, validation)
- Deep knowledge of CMC, GMP, and global regulatory frameworks (ICH, FDA, EMA)
- Proven experience with regulatory submissions and health authority interactions
- Demonstrated ability to lead in a complex, global matrix organization Preferred Qualifications
- Experience managing broad and complex small molecule drug product portfolios
- Strong track record in commercial manufacturing support and lifecycle management
- Experience in digital transformation and advanced manufacturing technologies
- Demonstrated success in leading cross-functional CMC/LCM teams
- Exposure to continuous manufacturing, PAT, and data science applications
- Strong external network within the pharmaceutical and scientific community Leadership Profile Strategic & Visionary
- Translates scientific and business trends into actionable strategies Results-Oriented- Drives execution with accountability and measurable impact Influential Leader
- Aligns stakeholders across complex environments Collaborative - Enables cross-functional and cross-site success Decisive
- Makes sound decisions in uncertain environments Strategic
- Translates key business trends and scientific developments into clear, actionable plans Continuous Improvement Mindset
- Embeds operational excellence and innovation People Developer
- Builds strong teams and future leaders