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Sanofi Group Lab Head Downstream, Associate Director in Framingham, Massachusetts

Associate Director, Downstream Processing

The Associate Director, Downstream Processing (DSP) position is part of Process Science in Global Manufacturing Science & Technology (MSAT) within Specialty Care Industrial Operations (SCIO). The MSAT function assures robustness and economics of Biologics manufacturing process life cycle management (LCM) by

  • Drive NEXT generation LCM process development & support key strategic initiatives (such as Continuous Processing and Facility of Future)

  • Lead scale-up development & adaptation, process control strategy, process validation, Tech transfer for Biologics products at Sanofi and external Industrial sites

  • Provide technical leadership to commercial manufacturing, quality, regulatory, and business at sanofi & external sites including change control assessment, process monitoring, complex troubleshooting and continuous improvement

MSAT-Process Science is the process owner of all SCIO manufacturing processes and associated process control strategies for Biologics Platform

Associate Director of DSP will play vital leadership role in manufacturing sciences and technologies. The role requires management of a lab operation team to conduct scaled-down experiments to support manufacturing investigation and improvement. The MSAT labs cover the upstream and downstream aspects of the drug substance manufacturing process and focus on improving the understanding, robustness and economics of commercial manufacturing processes. The successful candidate will be part of the leadership team and is responsible for providing technical and organizational leadership of respective lab unit by performing the following key duties:

  • Lead lab scientists to build Next generation process development and improvement, conduct complex technical troubleshooting, define process control strategy and continuous verification, support commercial manufacturing and global tech transfer

  • Provide technical insight to global MSAT process and analytical topics, LCM program management, operation and quality

  • Work collaboratively with other leaders from Global MSAT, R&D, drug product manufacturing and supporting services to build and execute integrated project timelines within the core project team

  • Establish and maintain familiarity with contemporary industrial standards, practices and technology focused on the full range of upstream and downstream process and ways of performing lab studies

  • Maintain awareness of current process and product control strategies, and contribute to improvement in process understanding and in-process control strategies as applied to upstream or downstream process steps

  • Lead or Contribute to establishment & deployment of best practices and technical way of working within Global MSAT teams

  • Develop talent by active and effective people management

  • Provide scientific mentorship to junior staff and establish team’s reputation by internal/external scientific partnership and publication in Biopharma community

Basic Qualification:

*Degree in life sciences, engineering or equivalent; BS with 15+ years, MS with 10+ years, PhD with 8+ years relevant experience

*Hands-on experience in biologics development, bioprocess engineering and/or commercial manufacturing operations

*Prior experience with leading project and managing technical staff

*Approximate 10% Travel maybe needed

Preferred Qulification:

*In-depth technical expertise in protein purification and knowledge in cell culture, analytical, and formulation/stability preferred

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.

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.

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