CMC Synthetics Clinical Manufacturing Leader

Main Responsibilities:
- Act as a CMC core team member accountable for sourcing clinical DS and DP supplies.
- Define project needs in terms of clinical manufacturing.
- Gather short-, mid-, and long-term activity forecasts.
- Establish, update, and communicate sourcing plans.
- Lead sourcing strategy (internal vs. external) and CDMO selection.
- Oversee manufacturing operations (internal or external) from kick-off to activity closure.
- Coordinate planning alignment between internal and external manufacturing.
- If reinternalization: co-lead CDMO-to-internal pilot process transfer (with Process Chemistry and Process Engineering/DP Design).
- Track project progress and key events (externally or internally).
- Provide technical/scientific input and actively challenge.
- Prepare Requests for Proposal (RFPs).
- Participate in regular meetings with external partners.
- Review and approve GMP documents (e.g., Technical Conditions, Master Batch Record).
- Track quality events (change controls, deviations) and integrate into Sanofi quality system.
- Serve as local point of contact for outsourcing; communicate and collect outsourcing needs.
- Support vendor management for US-based CDMOs.

Qualifications:
- Pharm.D. or PhD in Pharmaceutics, Chemistry, Chemical Engineering, or related.
- Minimum 5 years’ industry experience in Drug Substance and/or Drug Product manufacturing.
- Trained/experienced working in a GMP environment.
- Strong ability to work transversally in complex international, multi-cultural, changing environments.
- Experience with CDMOs and managing outsourced activities, collaborating with internal manufacturing pilots.

Preferred Skills:
- Good communication skills.
- Strong teamwork and cross-functional collaboration.
- Ability to make proposals and prioritize in a complex, changing environment.

Benefits:
- Health and wellbeing benefits, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.