Sanofi
Biopharma
CMCSyntheticsClinicalManufacturingLeader
“CMC Synthetics Clinical Manufacturing Leader at Sanofi. Skills: Drug Substance and/or Drug Product manufacturing, GMP environment, CDMO management, Outsourced activities management. Coordinate and oversee internal and external GMP clinical manufacturing activities. Act as a representative of clinical manufacturing activities within the CMC core project team”
What You'll Achieve.
Delivery of clinical drug substance and drug product batches in full compliance with project requirements, Sanofi policies and GMP regulation; Supplying clinical trials with drug substance and drug product
Industry & Context.
Actively challenge and provide technical / scientific input; Ability to make proposals and prioritize in a complex and changing environment
What They're Looking For.
Must Have
Pharm. D. or PhD in Pharmaceutics, Chemistry, Chemical Engineering or related, Minimum 5 years of 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
Nice to Have
Good communication skills, 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
What You'll Do.
Coordinate and oversee internal and external GMP clinical manufacturing activities
Act as a representative of clinical manufacturing activities within the CMC core project team
Act as a local representative for both Project Oversight and External Technologies teams
supporting locally the teams in external sourcing activities
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 from project team short
mid and long-term forecast of activities
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
Co-lead process transfer from CDMO to internal pilots (with Process Chemistry and Process Eng. /DP Design for DS/DP) in case of reinternalization
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
Ensure tracking of quality events (Change controls
Deviations) and appropriate integration in Sanofi quality system
Outsourcing management local point of contact
Communicate on outsourcing processes
Collect project outsourcing needs
Support vendor management for US based CDMOs
How You'll Work.
Team & Collaboration
Work transversally in complex international, multi-cultural and changing environment; Collaborate across functions; Close collaboration with Sanofi manufacturing pilots; Participate in regular meetings with external partners; Act as a CMC core team member; Act as a representative of clinical manufacturing activities within the CMC core project team
Communication Scope
Good communication skills; Communicate on outsourcing processes
Process & Methodology
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, Closely follow manufacturing operations, Coordinate planning alignment, Ensure appropriate follow up of project progress, Prepare Requests For Proposal, Track quality events
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