Sanofi Group Global Head, Purification Development in Framingham, Massachusetts

Sanofi tirelessly continues on its path towards becoming a world-class biologics organization and it is expanding the capabilities in this area. Biologics Development, responsible for all aspects of biologics CMC, is a key enabler in this ambition 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.

The Global Head of Purification Development will report to the Global Head of Biologics Development and will be responsible for all purification process development and viral safety 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.

  • Purification Development: Development of purification processes for Sanofi‚Äôs therapeutic protein pipeline, for both batch and continuous processes, for all stages of development.

  • Viral Safety: Development of appropriate viral clearance steps to ensure adequate viral safety and ensure viral clearance evaluation at CROs

  • Process Characterization: Responsible for process characterization, and parameter criticality assessment in preparation for process validation activities; including small scale validation such as column lifetime evaluation.

  • Regulatory Submissions: Responsible for authoring of relevant regulatory sections

  • Support technology transfer of DS manufacture and associated process troubleshooting.

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

  • Responsible for a team of over 80 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 QUALFICATIONS

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

Technical Skills & Competencies / Language

  • Should have demonstrated ability to develop purification processes for large number of therapeutic proteins of different modalities (mAbs, fusion proteins, bispecifics etc).

  • 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 cell culture, protein engineering, analytical sciences, formulation, data sciences, informatics, etc.

Behavioral 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 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