Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

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Job title:CMC BioDev Upstream Scientist

• Location: Vitry sur Seine

About the job

We are seeking an Upstream Process Development Scientist to lead upstream process development for early-stage biopharmaceutical candidates. In this role, you will serve as the USP technical lead for clinical development projects, driving process optimization and scale-up activities using CHO cell culture platforms across multiple culture modes including fed-batch, perfusion, and intensified cultures. You will work in a dynamic, cross-functional environment, balancing timely project delivery with contributions to our global cell culture platform evolution.

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Main Responsibilities

Project Leadership (USP Lead - Early Stage Development):

• Lead upstream process development activities for early-stage clinical candidates, serving as the technical expert and decision-maker for USP aspects across fed-batch, perfusion, and intensified culture strategies
• Design, execute, and analyze experiments to characterize and optimize cell culture processes for clinical manufacturing readiness using advanced platforms including Ambr250 systems
• Implement and optimize ATF (Alternating Tangential Flow) technology for perfusion culture applications
• Drive process development timelines, ensuring deliverables meet project milestones and support regulatory filings
• Leverage automated culture systems and drive process automation initiatives to enhance efficiency and data quality
• Apply statistical design of experiments (DOE) and advanced data analysis using JMP or equivalent visualization and statistical software to drive process understanding
• Collaborate cross-functionally with analytical development, downstream processing, manufacturing, and regulatory teams to ensure integrated process development
• Troubleshoot process issues and implement science-based solutions to advance development programs
• Prepare technical documentation and present development strategies and results to project teams and stakeholders
• Support technology transfer activities to clinical manufacturing sites, ensuring robust process implementation
• Contribute to regulatory documentation and new drug submission dossiers, providing clear technical writing on upstream process development sections

Platform & Global Collaboration:

• Apply and contribute to the evolution of the cell culture platform, proposing relevant improvements based on project learnings
• Participate in the global cell culture team, implementing harmonized practices and sharing knowledge across sites
• Contribute to best practice development and continuous improvement initiatives
• Apply understanding of commercial upstream bioprocess development to guide early-stage decisions

About you

Required:

• Master’s degree in biotechnology, Biochemical Engineering, Cell Biology, or related scientific discipline with 0+ years of relevant industrial experience
• Strong hands-on experience with CHO cell culture development and optimization across multiple culture modes (fed-batch, perfusion, intensified cultures)
• Demonstrated experience with lab-scale bioreactor operations (benchtop systems as well as Ambr250) in sterile environments
• Proficiency with ATF technology or similar perfusion systems
• Strong proficiency with statistical and data visualization software (JMP or equivalent tools) - this is a must-have skill
• Comfort with automated culture systems and process automation
• Demonstrated ability to design experiments (DOE), analyze data, and draw scientific conclusions
• Experience working in cross-functional project teams
• Strong communication skills in English, with ability to present technical information effectively both verbally and in writing

Preferred:

• Experience in early-stage biopharmaceutical development
• Understanding of commercial upstream bioprocess development considerations
• Experience contributing to regulatory documentation and new drug submission dossiers
• Knowledge of regulatory requirements for biologics development
• Experience with process scale-up and technology transfer
• Experience in statistical design of experiments (DOE) and multivariate data analysis
• Experience with process analytical technology (PAT) and real-time monitoring systems

Key Competencies:

• Scientific Excellence: Strong foundation in cell culture biology, bioprocess engineering, and analytical thinking with expertise across diverse culture modes
• Technical Leadership: Ability to drive technical decisions across complex culture strategies and advanced technologies
• Data-Driven Decision Making: Strong analytical skills with proficiency in statistical tools and data visualization
• Project Leadership: Ability to drive projects forward, make technical decisions, and meet timelines
• Problem-Solving: Creative and systematic approach to troubleshooting and process optimization
• Collaboration: Effective cross-functional teamwork and communication across global teams
• Adaptability: Comfortable working in fast-paced environments with evolving priorities and new molecules
• Innovation: Balance between leveraging platform approaches and proposing relevant improvements
• Regulatory Awareness: Understanding of how development decisions impact regulatory submissions and commercial manufacturing

Working Environment:

• Laboratory-based position requiring work in sterile environments with aseptic techniques
• Collaboration with global teams across multiple time zones
• Dynamic, project-driven environment with opportunities for scientific growth
• Work with state-of-the-art automated and high-throughput culture systems

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. and improve people's lives? Let's Pursue Progress and Discover Extraordinary – together. equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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