CMC Project Lead, Synthetics

CMC Project Lead, Synthetics

Location : Framingham, MA, Cambridge, MA

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

As part of Global CMC Project Management group within R&D CMC Development, the CMC Project Leader is responsible to develop the CMC strategy for Synthetics Projects, manage the associated risks and drive the execution plan aligned with the Global Project Team objectives from early phases of clinical development through the first approvals.

We are an innovative global healthcare company with one purpose : to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

Main Responsibilities :

• The CMC Project Leader leads a cross-functional CMC team with representatives from CMC Development, Manufacturing and Supply, Quality, Dossiers, Regulatory, Demand and Supply,
• He / she creates with the CMC team a strategic and integrated CMC development plan based on global project objectives ensuring alignment with base case and accelerated plans and exploring opportunities for acceleration.
• He / she coordinates the execution of the development plans aligned with the CMC stage gate deliverables in a timely manner.
• He / she represents CMC as a core team member in the Global Project Team, contributing to the program strategy, providing consolidated recommendations to the Global Project Team and piloting / executing the appropriate actions within the CMC team to achieve the project goals.
• He / she implement the R&D / M&S governance for Synthetics projects and present the deliverables to the governance bodies at the different milestones for endorsement.
• He / she ensures that the project development follows actual standards and define the Quality Target Product Profile (QTPP) and product development targets. He / she is accountable for the timing and the quality of the CMC contributions to pre-clinical, clinical and validation (DS / DP), and CMC elements for regulatory submissions and consultations.
• He / she evaluates the CMC risks and proactively implement mitigation plans, and ensure appropriate escalation to Senior Management (e.g. Sponsor & Global Management as needed) and Global Project Team (Project Direction). He / she timely alert decision makers and stakeholders on project strategy and risks that can impact critical program timelines, resource planning or the budget. In case of scientific / technical issues coordinate corrective measures across functions in cooperation with local department heads & global functions as needed. He / she owns the communication of project specific CMC related topics and ensure appropriate engagement of functional leaders and key stake holders.

About You

Education & Experience :

Technical Skills & Competencies / Language :

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Why Choose Us?

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.