Sanofi Group Cell Culture Process Development Scientist in Waltham, Massachusetts
The Genomic Medicine Unit (GMU) 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. This organization encompasses vector and cell line engineering, upstream and downstream process development, analytics, and clinical manufacturing support.
The Genomic Medicine Cell Culture Process Development group is responsible for the development of AAV and Lentiviral vector production optimization and development of next generation production platforms to support high dose therapeutic products.The Scientist 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 production processes consistent with patient safety standards.
We are looking for a candidate with experience in AAVand/or LVcell culture development, high throughput screening models (e.g. Ambr 250), scale-up and manufacturing, and technology transfer.
Key Responsibilities :
Independently develop, design and conduct viral vectorproduction experiments and evaluate new technologies to increase product yield and process understanding using design of experiment.
Develop, maintain and demonstrate advanced knowledge of principals and techniques in cell culture, bioreactor operation, viral vector production, process intensification and media development.
Maintain industry knowledge and awareness of new and relevant technologies, and be willing to publish findings as well as speak both internally and externally as industry leaders.
Lead development of study design, optimization of production process conditions, media screening and perform troubleshooting experiments and communicate findings with appropriate working groups.
Perform data analyses, write protocols, author development technical reports, contribute to regulatory findings and provide internal and external presentations.
Lead scale-up activities to implement a manufacturing process based on applied cell culture 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.
Assist fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency.
Mentor and support junior staff and build a culture of support and collaboration.
Perform extended hours, weekend and holiday work to support ongoing lab activities.
PhD in biological sciences or related discipline or Master’s degree with a minimum of 4 years of relevant experience or a Bachelor’s degree with a minimum of 6 years of relevant experience.
Strong understanding of mammalian cell growth and virus production.
Experience in CMC and drug development cycle
Advanced knowledge of principles and techniques in viral vector production.
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, and ability to draft manuscripts for external publications.
Ability to work in Biosafety Level 2, follow safe lab procedure and maintain good laboratory practice (GLP).
Excellent communication skills.
Extensive understanding of analytical tools and calculations such ascell counting, oxygen uptake rates, metabolite consumption rates, viral vector titer and product quality assessments.
Experience writing CMC components of regulatory dossiers.
Experience performing viral vector analyses.
Knowledge of product comparability, target product profile and quality risk assessment activities.
Late-stage process development experience such as design space mapping and process robustness studies.
Experience with large-scale unit operations.
Innovative, critical and creative thinker.
Experience inmentoringjunior staff.
Ability to build and nurture cross-functional relationships.
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.
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.