CMC Synthetics Clinical Manufacturing Leader

Job Title

CMC Synthetics Clinical Manufacturing Leader

Cambridge, MA

• Act as a CMC core team member accountable for sourcing of clinical drug substance (DS) and drug product (DP) supplies.
• Define project needs in terms of clinical manufacturing.
• Gather from project team short, mid and long‑term forecast of activities.
• Establish, update and communicate sourcing plans.
• Lead sourcing strategy: internal vs external, as well as CDMO selection.
• Closely follow manufacturing operations done internally or externally from kick‑off to activity closure.
• Coordinate planning alignment between internal and external manufacturing activities.
• In case of reinternalization, co‑lead process transfer from CDMO to internal pilots (with Process Chemistry and Process Engineering/DP Design for DS/DP).
• Ensure appropriate follow‑up of project progress (either externally or internally) and key events.
• Actively challenge and provide technical/scientific input.
• Prepare Requests for Proposal.
• Participate in regular meetings with external partners.
• Review and approve all GMP documents (Technical Conditions, Master Batch Record, …).
• Ensure tracking of quality events (Change controls, Deviations) and appropriate integration into Sanofi quality system.
• Outsourcing management local point of contact.
• Communicate on outsourcing processes.
• Collect project outsourcing needs.
• Support vendor management for US‑based CDMOs.

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

• Good communication skills.
• Strong teamwork and ability to collaborate across functions.
• Ability to make proposals and prioritize in a complex and changing environment to support efficiently a diversified and very dynamic portfolio.

The salary range for this position is: $ - $.

All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital status; 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.