Sanofi Group Global Head, Cell Culture Development in Framingham, Massachusetts

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 the Global Head of Biologics Development and will be responsible for all aspects of cell line and cell culture process development activities with staff in three global 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.

Developing long-term strategy, and corresponding aggressive goals to propel Biologics Development at Sanofi to become one of top 3 in the industry.

  • Cell line development: Development of production cell lines for expression of therapeutic proteins, and related technologies for improving efficiency and expression levels

  • 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‚Äôs 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 mfg and troubleshooting of manufacturing batches

  • Define vision and strategic plan for Cell culture to accommodate new modalities and technology evolution

  • Responsible for a team of over 100 scientists and engineers in three sites (Frankfurt, Germany; Vitry, France, and Framingham, MA, USA).

BASIC QUALIFICATIONS

Education

  • Ph.D. in Chemical / Biochemical Engineering, or a related field.

Experience

  • At least 15 years relevant industrial experience with at least 5 years managing a large team (>30) of scientists / engineers.

PREFERRED QUALIFICATIONS

  • Global leadership experience leading / influencing multi-cultural teams is highly desired.

  • Should have demonstrated ability to develop cell culture processes for large number of therapeutic proteins of different modalities (mAbs, fusion proteins, bispecifics etc), high titer platform media / feed, and robust cell lines.

  • Demonstrated passion for scientific innovation through patents, publications and presentations.

  • 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

  • Leadership of CMC team(s), demonstrating 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.

Behavioural Competencies

  • Working closely with technology transfer and manufacturing (clinical and commercial), will help translate lab processes to robust commercial processes

  • Will be able to influence colleagues in other functions to achieve common goals

  • May be asked to lead high level teams across the company to achieve strategic goals

  • Will collaborate with academia, other companies to develop new technologies / products

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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life