CMC Synthetics Clinical Manufacturing Leader
Sanofi
June 26, 2026
Remote friendly (Cambridge, MA)
United States
$148,500 - $214,500 USD yearly
Operations
Main Responsibilities:
- Act as a CMC core team member accountable for sourcing of 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 internal/external manufacturing operations from kick-off to activity closure.
- Coordinate planning alignment between internal and external manufacturing activities.
- If reinternalization occurs: co-lead CDMO-to-internal pilot process transfer (with Process Chemistry and Process Eng./DP Design for DS/DP).
- Ensure follow-up of project progress and key events.
- Provide technical/scientific input.
- 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 outsourcing processes 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 of industry experience in Drug Substance and/or Drug Product manufacturing.
- Trained/experienced working in a GMP environment.
- Ability to work transversally in complex international, multi-cultural, changing environments.
- Experience working with CDMOs or managing outsourced activities with close collaboration with manufacturing pilots.
Preferred Qualifications/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, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Act as a CMC core team member accountable for sourcing of 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 internal/external manufacturing operations from kick-off to activity closure.
- Coordinate planning alignment between internal and external manufacturing activities.
- If reinternalization occurs: co-lead CDMO-to-internal pilot process transfer (with Process Chemistry and Process Eng./DP Design for DS/DP).
- Ensure follow-up of project progress and key events.
- Provide technical/scientific input.
- 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 outsourcing processes 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 of industry experience in Drug Substance and/or Drug Product manufacturing.
- Trained/experienced working in a GMP environment.
- Ability to work transversally in complex international, multi-cultural, changing environments.
- Experience working with CDMOs or managing outsourced activities with close collaboration with manufacturing pilots.
Preferred Qualifications/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, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.