External Manufacturing and Supply Lead

Job title: External Manufacturing and Supply Lead

Location: Waltham, MA

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

As External Manufacturing and Supply Lead within our Genomic Medicines Unit (GMU) CMC Development team, you’ll help manage constructive vendor relationships to build reliable manufacturing supply of our outsourced clinical and non-clinical materials and critical raw materials to support Sanofi’s genomic medicine pipeline.  Ready to get started?

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In CMC Development, you’ll drive breakthroughs and help reimagine how life-changing treatments reach people everywhere, faster.

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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Act as primary point of contact for all Sanofi activities at assigned Contract Development and Manufacturing Organization (CDMO).  Support New Product Introduction and Technology Transfer to deliver product supply on-time and on-budget.

• Own and deliver CDMO contracts, PO’s, and reconciliation/validation of invoices.

• Drive both internal and external stakeholders to meet agreed upon timelines for manufacturing readiness, production execution, and release. 

• Coordinate and establish external governance meetings (e.g. joint steering committees).

• Support internal Quality and Technical teams to drive CDMO deviation/investigation closure.  Responsible for owning Sanofi’s internal Quality records (including but not limited to Deviations and Change Controls).

• Lead continuous improvement initiatives to drive positive change at CDMO including but not limited to raw materials strategy and time-to-release performance.

• Establish effective internal Ways of Working to address knowledge gaps and proactively resolve issues.

• Responsible for GMID creation and SAP inventory movements for externally manufactured materials.

About you

Qualifications

• Master’s degree in Medical, Life Science or related field with a minimum of 8 years of relevant experience or a Bachelor’s degree with a minimum of 10 years of relevant experience
• 5+ years of experience in Gene Therapy/Vaccine/Biologics Drug Development and/or Manufacturing
• Proven success in Project Management working with virtual global teams
• Experience in Technology Transfers and new product launches
• At least 3+ years of experience managing suppliers and CDMOs within the pharmaceutical industry
• Adept at communicating to both senior and operational level internally and externally
• Excellent critical thinking to make strategic and tactical decisions to support the business and ensure continuous supply
• Self-starter, results-oriented, and able to prioritize tasks
• Strong ability to influence effectively and negotiate internally and externally across matrixed network of stakeholders and decision makers

Preferred Qualifications:

• Understanding of the Gene Therapy drug development and manufacturing processes, of relevant cGMP requirements, and knowledge in the manufacturing of sterile solutions and suspensions

Special Working Conditions:

• Ability to travel, domestic and international, up to 15%