CMC Synthetics Clinical Manufacturing Leader

Sanofi•Cambridge, MA

16h•Onsite

About The Position

The Projects and External Technologies team, part of the CMC Synthetics organization within Sanofi R&D, is responsible for the delivery of clinical drug substance and drug product batches in full compliance with project requirements, Sanofi policies and GMP regulation, leveraging internal and external manufacturing capabilities. We are looking for a highly motivated and collaborative individual with expertise in drug substance or drug product manufacturing to join our team. Under the direction of Projects and External Technologies department head, the primary responsibility of this role is to coordinate and oversee internal and external GMP clinical manufacturing activities, with the aim of supplying clinical trials with drug substance and drug product. The Clinical Manufacturing Team Leader will act as a representative of clinical manufacturing activities within the CMC core project team. The Clinical Manufacturing Team Leader based in the US will also act as a local representative for both Project Oversight and External Technologies teams, supporting locally the teams in external sourcing activities. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Requirements

Pharm. D. or PhD in Pharmaceutics, Chemistry, Chemical Engineering or related.
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.

Nice To Haves

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.

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 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 Eng./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 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.