CMC Demand & Supply Leader

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* Job Title:

** CMC Demand & Supply Leader

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* Location:

** Framingham, MA

** 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.

This role offers the opportunity to join a dynamic and skilled team at a pivotal time as we strengthen our in-house expertise, accelerate digital transformation initiatives, and build sustainable internal capabilities to support an increasing portfolio of innovative projects across multiple therapeutic areas.

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

** 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.

** Main Responsibilities*
* + 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.

** About You*
* Basic Qualifications

** Education*
* +  
** PhD
* * in 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

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** OR Bachelor of Science (BS)
** degree in any of the above fields

+  _Related scientific or life sciences disciplines will be considered_

** Experience*
* +  
** PhD holders:
** Minimum3 years in Research and Development or Clinical Development.

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** Master's holders:
** Minimum5 years in Research and Development or Clinical Development.

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** Bachelor's holders:
** Minimum8 years in Research and Development or Clinical Development.

+ Minimum 2 years in Demand Management in Research and Development in the domain of Oncology, Immuno-inflammation, Rare Disease, Neurology, or Multiple Sclerosis (included within total years of experience, not additional)

+ CMC experience.

+ Ability to navigate complex and regulated environments (GMP and GCP regulations)

+ Knowledge of data analytics and forecasting

+ Project Management experience

Preferred Qualifications

+ Experience in the development of diverse modalities (Mammalian, Genomic, Microbial, Synthetics)

+ Excellent knowledge of Projects Development, Clinical & Preclinical Development, Clinical Supply Chain, CMC, R&D and M&S interfaces

+ PMI certification

+ Experience in Power BI/Power App and project management software

+ Experience in management of co-development projects, companies' integration and contracts management

+ Knowledge of Industrial Supply Chain principles

+ Strong interpersonal/networking skills, team-work and transversal collaboration

+ Ability to understand complex processes quickly and act as referent for the department

+ Strong ability…