Global Head, Cell Culture Process Development
Framingham, Massachusetts, Vitry-sur-Seine, France
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Global CMC Development, responsible for all aspects of biologics CMC, is a key enabler of Sanofi’s growth aspiration through its mission to develop manufacturing processes, formulations, and analytical methods as well as to scale up and manufacture clinical trial material. Developing new and disruptive technologies is our passion.
In order to accelerate our ambition to become an industry leader in this field, we are seeking to hire the Global Head of Cell Culture Development who will report to Global Head of Mammalian Platform. The Global Head of Cell Culture Development will be responsible for all aspects of cell culture process development activities with staff in the US and EU sites. As such, this is an extremely visible position with the potential to make a huge difference to Sanofi and to the patients we serve.
Develop long-term strategy, and corresponding aggressive goals to propel Biologics Development at Sanofi to become one of top 3 in the industry by:
Medium / Feed development: Development of platform medium / feed that would result in robust, industry leading titers for fed-batch and continuous manufacturing processes
Process Development: Develop fed-batch and continuous cell culture processes for Sanofi’s growing portfolio of products, at all stages of development
Process Characterization: Responsible for process characterization, and parameter criticality assessment in preparation for process validation activities
Regulatory Submissions: Responsible for authoring of relevant regulatory sections
Support technology transfer to DS manufacturing and troubleshooting of manufacturing batches
Define vision and strategic plan for Cell culture to accommodate new protein formats and technology evolution
Responsible for a team of over 70 scientists and engineers at US and EU sites.
Leadership of high level teams across the company to achieve strategic goals
Collaborate with academia, other companies to develop new technologies / products
PhD in Chemical / Biochemical Engineering, or a related discipline with a minimum of 13 years relevant industrial experience or a Master's or Bachelor's degree with a minimum of 17 years of relevant experience
Minimum of 5 years experience managing large teams
Demonstrated ability to develop cell culture processes for large number of therapeutic proteins of different modalities (mAbs, fusion proteins, bispecifics etc) at any stage of development (clinical and commercial process development), high titer platform media / feed, and robust cell lines.
Experience in transfer of process to clinical and/or commercial site, and scaling up to ~10,000L bioreactor scale.
Experience with process modeling / process controls, using mathematical / statistical approaches
Experience with scale-up / scale-down of processes and use of high throughput systems.
Development of products leading to successful regulatory approval, demonstrating a thorough knowledge of regulatory requirements from various health authorities
Demonstrated knowledge of various aspects of biologics drug development.
Sound knowledge of related areas such as protein engineering, purification, analytical sciences, formulation, data sciences, informatics, etc.
Global leadership experience leading / influencing multi-cultural teams
Demonstrated passion for scientific innovation through patents, publications and presentations.
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.
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.
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