Job Title: CMC Synthetics Clinical Manufacturing Leader
Location: Cambridge, MA
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 youBasic 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.
The salary range for this position is:
$148.500,00 - $214.500,00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
