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Sanofi Group Associate Director, GMU CMC Purification Process Development in Waltham, Massachusetts

Position Overview:

The Genomic Medicine Unit (GMU) Chemistry, Manufacturing and Control (CMC) group at Sanofi is dedicated to the establishment of best in class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors and cell therapy products. Sanofi is looking for an experienced purification process development professional with experience in viral vector purification to join the Genomic Medicine Purification Process Development Group located in Waltham, MA in the role of Associate Director. The Genomic Medicine Purification Process Development group within Sanofi operates with the mission to develop robust, scalable and innovative viral vector purification processes for Sanofi’s genomic medicine pipeline.

The successful applicant will lead a group of scientists and engineers responsible for the development of viral vector purification processes, technology transfer to manufacturing sites, overseeing process scale up operations, defining scale down models, and authoring of associated regulatory filing activities. The individual will also actively be working on new technology development and platform process improvements to reduce manufacturing cost of goods (COGs). We are looking for a candidate with excellent scientific, communication, and people and project management skills.

Key Responsibilities:

  • Lead a group of scientists and engineers responsible for the development of viral vector purification processes and technology transfer to manufacturing sites.

  • Oversee the process development and scale-up operations, defining scale down models and authoring associated regulatory filing activities.

  • Responsible for successful viral vector process development, process characterization and execution of purification manufacturing processes .

  • Establish and link viral vector biology/molecular understanding with viral vector process development understanding.

  • Lead projects to develop and implement industry leading and innovative viral vector purification production technologies.

  • Drive innovation, technology development and platform improvement to enhance viral vector productivity, quality, and consistency.

  • Present findings and/or results to senior management, external stakeholders, and industry leaders at national/international conferences.

  • Author manuscripts and patent applications.

  • Make strong technical and strategic contributions to cross functional development project teams.

  • Build strong interfaces with GMU CMC community and help drive adoption of best practices.

Basic Qualifications:

  • PhD degree in Biotechnology, Cell Biology, Biochemistry, Chemical Engineering or related discipline with a minimum of 8 years of relevant experience or a Master’s degree with a minimum of 12 years of experience.

  • Experience in the biotech/pharmaceutical industry within a purification process development role and an excellent understanding of the theory and practice of purification process development is required.

  • Molecular understanding of viral vector productions, in particular Adeno-Associated Virus and Lentivirus biology, is highly desired.

  • Strong downstream expertise and knowledge pertaining to AAV and/or LV production.

  • Strong understanding of the principles of Quality by Design (QbD), high-throughput process development (HTPD) and ability to apply DOE to downstream development.

  • Experience in viral clearance study design and study execution at CMO.

  • Knowledge of product comparability, target product profile and quality risk assessment activities.

  • Ability to manage multiple projects in parallel, including key participation in cross functional project and innovation teams.

  • Experience in executing projects to aggressive timelines with the ability to adapt to rapid changes in project priorities.

  • Minimum of 5 years of experience managing direct reports or project teams.

  • Excellent communication skills to build relationships both inside and outside the purification process development function.

Preferred Qualifications:

  • Experience in managing cross functional teams and leading innovation initiatives.

  • Experience in applying PAT, continuous processing and process intensification to purification process development.

  • Late-stage purification experience such as design space mapping and process robustness studies.

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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