CMC Demand & Supply Leader

About The Job

Within CMC function, in the Global CMC Project Management department, the ambition is to expand a strong End to End R&D Supply Demand integrating Demand Forecast & Planning of Supplies, supporting Projects Development and Operations through the entire value chain (from R&D to LCM). With the aim of developing a Demand & Supply Center of Excellence, the mission of the Demand & Supply Leader is to integrate Project Strategy, Clinical and CMC Operational plans for an early definition and optimization of E2E Demand & Supply plan while considering cost & risk to support execution of Projects in respect to Regulatory and Quality requirements.

CMC Demand & Supply Leader

Framingham, MA

Within CMC function, in the Global CMC Project Management department, the ambition is to expand a strong End to End R&D Supply Demand integrating Demand Forecast & Planning of Supplies, supporting Projects Development and Operations through the entire value chain (from R&D to LCM). With the aim of developing a Demand & Supply Center of Excellence, the mission of the Demand & Supply Leader is to integrate Project Strategy, Clinical and CMC Operational plans for an early definition and optimization of E2E Demand & Supply plan while considering cost & risk to support execution of Projects in respect to Regulatory and Quality requirements.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives.

• Lead collaborative work with Global project Management, Clinical Development and CMC to define clinical assumptions and CMC hypothesis to forecast Clinical Demand.
• Forecast Long Range Plan Demand based on assumptions worked with interfaces.
• Consolidate non-clinical & clinical demand and propagate to M&S Global Supply Chain.
• Integrate all Development Demand and align with operational plans (CMC, CSO, TMED, DMPK, PCS) and Regulator submission/approval plans.
• Run forecast & alignment scenario with associated risks and costs to support strategic project decisions and budget definition.
• Co-lead Demand & Supply Sub Team and ensure End to End supply optimization with the contribution of key stakeholders.
• Accountable for defining the best sourcing and supply strategy for marketed products/comparators, including forecast and budget.
• Lead the definition of drug products blinding strategy to ensure clinical trial products in distinguishability.
• Ensure DS/DP batches allocation to IMP batches and on time products delivery to packaging sites and oversee associated Material Flow & Documentation management.
• Provide reporting/KPIs to monitor & improve Supply performance
• Contribute to project documents & meetings preparation by providing standard Demand & Supply Reports (e.g. IDCC/DWG/ORC, IDP, Operational plan, Supply agreement).
• Can support transversal initiatives contributing to simplification & harmonization.

Basic Qualifications

• PhDin Sciences (Neurosciences, Microbiology, Immuno-inflammation, Gene Therapy, Rare Diseases, Pharmaceutical Sciences, Biochemistry, Molecular Biology, Biotechnology, Biomedical Sciences, Genetics), Pharmacist, or Engineer in Health Sciences, Chemical Engineering, or Biomedical Engineering
• OR Master of Science (MS) degree in any of the above fields
• OR…