CMC Synthetics Clinical Manufacturing Leader

Job Title

CMC Synthetics Clinical Manufacturing Leader

Cambridge, MA

The Projects and External Technologies team, part of the CMC Synthetics organization within Sanofi R&D, delivers clinical drug substance and drug product batches in compliance with project requirements, Sanofi policies, and GMP regulations. The Clinical Manufacturing Team Leader will coordinate and oversee internal and external GMP clinical manufacturing activities, supplying clinical trials with drug substance and drug product while acting as a representative of clinical manufacturing activities within the CMC core project team.

The leader based in the U.S. will also serve as a local representative for project oversight and external sourcing activities.

• Act as a core CMC team member accountable for sourcing of clinical drug substance and drug product supplies.
• Define project needs in terms of clinical manufacturing and gather short, mid and long‑term forecasts from the project team.
• Establish, update and communicate sourcing plans, leading the sourcing strategy (internal vs external, CDMO selection).
• Oversee manufacturing operations internally or externally from kickoff to closure, coordinating alignment between activities.
• Co‑lead process transfer from CDMO to internal pilots when reinternalization is required.
• Ensure appropriate follow‑up of project progress and key events, providing technical and scientific input.
• Prepare Requests for Proposal, participate in regular meetings with external partners, and review and approve all GMP documents (Technical Conditions, Master Batch Record).
• Track quality events (change controls, deviations) and integrate them into the Sanofi quality system.
• Act as the local outsourcing management point of contact, communicating outsourcing processes and collecting project outsourcing needs.
• Support vendor management for U.S.‑based CDMOs.

• Pharm.
  
  D. or PhD in Pharmaceutics, Chemistry, Chemical Engineering or a related field.
• Minimum 5 years of proven industry expertise in drug substance and/or drug product manufacturing.
• Experience working in a GMP environment.
• Strong ability to work transversally in complex international, multi‑cultural, and changing environments.
• Experience managing outsourced activities and working closely with Sanofi manufacturing pilots.

• Excellent communication skills.
• Strong teamwork ability and cross‑functional collaboration.
• Proficiency in making proposals and prioritizing tasks in a complex, changing environment to support a diversified portfolio.

• Supportive, future‑focused team that brings the miracle of science to life.
• Opportunities for growth through promotions, lateral moves, and international assignments.
• Thoughtful rewards package that recognizes contributions and amplifies impact.
• Comprehensive health and wellbeing benefits, including gender‑neutral parental leave.
• Participation in patient‑centric drug development and use of advanced AI, data, and digital platforms.

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, sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, or genetic information.

No liability for military status. All compensation will be determined commensurate with demonstrated experience.