Global Head Of Cell And Gene Manufacturing

The Global Head of Cell and Gene Manufacturing is responsible for R&D cell and gene therapy internal and external GMP manufacturing to deliver clinical supplies, overseeing internal manufacturing groups and multiple external partners.
This role provides operations leadership and strategy in all areas of cell and gene therapy production to ensure an uninterrupted supply of quality clinical supplies. This role will also be a member of the Genomic Medicine Unit CMC Leadership Team
This role is responsible to shape and design the manufacturing strategy to enable Sanofi’s cell and gene clinical pipeline, driving a comprehensive way of working across multiple sites with a focus on GMP best practices, quality, and delivering on-time clinical supplies.
About The Role

• The focus for this position is to provide strategic and technical leadership within GMP manufacturing for the management of cell and gene therapy clinical supplies.
• Develop near and long-term strategy and plans associated with new process introductions, facility utilization and manufacturing flexibility to enable cell and gene therapy ambition.
• Build organizational and operational capability to meet the needs of the business
• Working closely with gene and cell therapy process development, analytical development, and drug product teams to ensure efficient technology transfer and effective manufacturing
• Partner with R&D quality to set phase appropriate GMP manufacturing standards for cell and gene therapy.
• Provide leadership to ensure a high level of communication and coordination within GMU manufacturing sites, addressing issues to meet production schedules
• Responsible for managing manufacturing operations relating to the global internal and external clinical manufacturing
• Embody the Sanofi Play to Win behaviors, leadership competencies and provide thoughtful and high-quality leadership.

Required Skills

• Extensive prior experience (>10 years) managing manufacturing teams delivering clinical supplies complying with US/EU and other global requirements under cGMP conditions
• Proficiency with manufacturing and business processes
• PhD degree or Master's degree in Biotechnology, Bioprocess Engineering or Chemical Engineering or related discipline with 15+ years' experience in pharmaceutical or biotech manufacturing environment
• Prior experience with Cell and Gene Therapy, vaccine, or biologics manufacturing
• Strong Communication and stake-holder management skills

Preferred Skills

• Prior experience in cell and gene therapy manufacturing operations
• Prior experience as biologics manufacturing site leader, facility design, supply chain management, operational excellence

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.