CMC Demand & Supply Leader

BioSpace; Framingham (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Sanofi in Framingham, MA seeks a CMC Demand & Supply Leader to integrate Project Strategy, Clinical and CMC plans for End to End Demand & Supply optimization across the value chain.

You will lead forecasting, development demand integration, and cross-functional collaboration while ensuring regulatory and quality requirements are met. This role drives strategic decisions and contributes to a center of excellence in Demand & Supply.

Qualifications

• PhD holders:Minimum3 yearsin Research and Development or Clinical Development.
• Master's holders:Minimum5 yearsin Research and Development or Clinical Development.
• Bachelor's holders:Minimum8 yearsin Research and Development or Clinical Development.
• Minimum 2 yearsin Demand Management in Research and Development in Oncology, Immuno-inflammation, Rare Disease, Neurology, or Multiple Sclerosis.
• CMC experience.
• Ability to navigate complex and regulated environments (GMP and GCP).
• Knowledge of data analytics and forecasting.
• Project Management experience.

Responsibilities

• Lead collaborative work with Global project Management, Clinical Development and CMC to forecast Clinical Demand.
• Forecast Long Range Plan Demand based on 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.

Skills

Forecasting

Data analytics

Project management

GMP/GCP knowledge

Regulatory collaboration

Education

PhD in Sciences or Pharmacist or Engineer

MS degree in life sciences

BS degree in life sciences

Tools

Power BI

Job description

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.

Job Title:

CMC Demand & Supply Leader

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.

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.

About Sanofi

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.

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 decisionsand 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 indistinguishability.
• 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

• 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 Bachelor of Science (BS)degree in any of the above fields
• Related scientific or life sciences disciplines will be considered

Experience

• PhD holders:Minimum3 yearsin Research and Development or Clinical Development.
• Master's holders:Minimum5 yearsin Research and Development or Clinical Development.
• Bachelor's holders:Minimum8 yearsin Research and Development or Clinical Development.
• Minimum 2 yearsin 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 Appand 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 to work under pressure and address complex situations
• Team management experienceis a plus

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.