COMPLETE Associate Director, GMU CMC Purification Process Development - Waltham, MA

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 Adeno-associated viral vectors (AAV), non-viral and cell therapy products. Sanofi is looking for a seasoned purification process development professional with experience in viral vector and non-viral gene therapy purification to join the Genomic Medicine Purification Process Development (PPD) 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 and non-viral purification processes for Sanofi’s genomic medicine pipeline. 

The successful candidate will lead a group of scientists and engineers responsible for the development of viral vector and non-viral purification processes, technology transfer to manufacturing sites, overseeing process scale up operations, defining scale down models, and authoring of associated regulatory filing documents.  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.

Job Duties and Responsibilities

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

• Oversee process development and scale-up operations, define scale down models and author associated regulatory filing documents

• Responsible for successful viral vector and non-viral process development, process characterization and process scale-up and scale-down

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

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

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

• Present findings and results to senior management, external stakeholders and industry leaders at internal meetings and external conferences

• Author manuscripts and patent applications

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

• Build strong interfaces within GMU CMC community and drive adoption of best practices and ways of working

Basic Qualifications

• PhD degree in Biotechnology, 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 biotechnology or biopharmaceutical industry with 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 and non-viral products, in particular AAV

• Strong downstream expertise and knowledge pertaining to AAV and non-viral gene therapy, is highly desired

• 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 execution at CRO

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

• Ability to manage multiple projects in parallel, including key participation in cross functional projects and technology development 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 process development experience, including design space mapping, process control strategies and CMC activities to support PPQ and BLA, etc.

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.