CMC Synthetics Clinical Manufacturing Leader

Job Title: CMC Synthetics Clinical Manufacturing Leader

Location: Cambridge, MA

About the Job 

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.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

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 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.

About you

Basic Qualifications:

• 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.

Preferred Qualifications:

• 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.

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

• Help improve the lives of millions of people globally by making drug development quicker and more effective.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, 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.

#GD-SA

#LI-SA

#vhd

#LI-Onsite

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.