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Sanofi Group Genomic Medicine Purification Process Development, Principal Research Associate 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.

The GMU purification process development group is responsible for the development of AAV and lentiviral vector processes and for supporting viral vector purification from next-generation production platforms to enable high-dose gene therapy programs. The Principal Research Associate, Purification Process Development role requires leadership both inside and outside the laboratory and will rely on industry expertise and the exploration of novel technologies in order to build robust and efficient purification processes consistent with patient safety standards.

We are looking for a candidate with experience in AAV and/or LV purification development, scale-up and manufacturing, and technology transfer.

Key Responsibilities:

  • Independently develop and/or support, design and conduct viral vector purification experiments and evaluate new technologies to increase product yield and process understanding.

  • Develop, maintain and demonstrate advanced knowledge of principals and techniques in column chromatography and other areas of downstream purification.

  • Maintain industry knowledge and awareness of new and relevant technologies, and be willing to publish findings and to speak both internally and externally as industry leaders.

  • Lead and/or support development of study design, optimization of purification process conditions, media screening and perform troubleshooting experiments and communicate findings with appropriate working groups.

  • Perform data analyses, contribute to technical reports and internal/external presentations.

  • Lead scale-up activities to implement a manufacturing process based on applied DSP knowledge.

  • Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities.

  • Contribute to manuscript and patent writing for external publications and patent applications, respectively.

  • Mentor and support junior staff and build a culture of support and collaboration.

Basic Qualifications:

  • Master’s degree in biological or engineering sciences with a minimum of 2 years of relevant industry experience or a Bachelor’s degree with a minimum of 4 years of relevant industry experience.

  • Knowledge of purification of viral vectors.

  • Experience in CMC and drug development cycle.

  • Significant experience, knowledge and understanding of purification technologies and operations such as:

  • Depth filtration

  • AKTA or automated protein purification chromatography

  • Tangential flow filtration or UF/DF

  • Virus clearance and inactivation

  • Filtration unit operations at various scales

  • Strong grasp of chromatography principles and modalities.

  • Familiarity with advanced purification technologies.

  • Experience with process technology transfers and performing gap analyses and risk assessments.

  • Strong understanding of the principles of Quality by Design and ability to apply DOE to downstream development.

  • Expertise in technical report writing.

  • Knowledge of basic analytical tools such as spectrophotometry, ELISA, HPLC, and SDS-PAGE.

Preferred Qualifications:

  • Experience in high throughput process development using TECAN or other liquid handlers.

  • Experience writing CMC components of regulatory dossiers.

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

  • Viral clearance study design and execution preferred.

  • Late-stage purification experience.

  • Experience with large-scale unit operations.

  • Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs).

  • Ability to work under minimal supervision and function within a collaborative, team-oriented environment.

  • Excellent organization and communication skills.

  • Ability to communicate and represent group in diverse, multi-functional meetings.

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.

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