Scientist – Lentiviral GT Upstream
The Gene Therapy Development and Manufacturing (GTDM) group in Sanofi is responsible for the design and optimization of viral vector manufacturing processes and platforms. This organization encompasses cell line engineering, upstream process development, downstream process development and analytical method development and platform innovation.
The Lentiviral Gene Therapy sub-group is responsible for the development of lentiviral vector process and application of next-generation viral vector production platforms to support high dose gene therapy products. The Scientist – Lentiviral GT USP will lead develop and build novel and efficient viral vector production systems and support other functions to bolster Sanofi's gene therapy manufacturing capabilities.
- Independently develop, design and conduct cell culture experiments and evaluate new technologies to increase cell culture process understanding
- Lead and perform media screening, clone selection, productivity optimization, scale up, technology transfer, process characterization, person-in-plan (PIP) and manufacturing activities
- Lead development of study design, optimization of process conditions and perform troubleshooting experiments
- Design and implement design of experiments (DoE), evaluate results, perform high throughput studies and implement continuous manufacturing concepts during development stages
- Perform data analyses, write protocol, author development reports, write standard operating procedures (SOPs) and technology transfer documents
- Innovate and introduce new technology, and present results to internal/external teams
- Develop, maintain and demonstrate advanced knowledge of principals and techniques used in cell culture areas and apply them to process intensification efforts
- Stay updated on new and relevant technologies, and publish article to drive innovation in internal and external scientific community
- Collaborate with internal and external teams, e.g. CMO, CDMO, and work with vendors and suppliers to evaluate technology and improve productivity
- Mentor and support junior staff and build a culture of support and collaboration
- Perform occasional extended hours, weekend and holiday work to support ongoing lab activities
- Bachelor's degree in biological sciences or related field with a minimum of 6 years of relevant experience or Master's degree in biological sciences with a minimum of 4 years of relevant experience
- Hands on experience of bioreactor systems (Ambr15 or Ambr250, Suspension culture SF, 5L, 10L) and cell culture optimization
- Hands on experience with viral vector upstream process development (e.g. lentiviral vector)
- Understanding of Bioreactor types, media screening, clone selection, product comparability, cell banking, cell biology and viral vector physiology with stronger scientific aptitude
- Expertise in DoE (Design of Experiments) using JMP or similar software and process optimization
- Experience of assays: qPCR, ddPCR, Flow Cytometry, ELISA, P24, viral vector characterization
- PhD in biological sciences and at least one year of relevant experience
- Demonstrated advanced knowledge of principles and techniques used in upstream processes
- Experienced with upstream process technology transfer, process characterization and scale up activities
- Understanding of late phase process development, GLP, GMP and regulatory submission activities
- Knowledge of Quality by Design (QbD) and experience with DoE's using JMP or equivalent software, and how it can be applied to cell culture processes
- Demonstrated ability to mentor junior level staff
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.
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