Principal Scientist, Cell Line Development Full-time NEW

Principal Scientist, Cell Line Development, Mammalian Platform, CMC

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We seek a highly motivated candidate to join Cell Line Development (CLD), responsible for generating mammalian cell lines for Sanofi's R&D Biologics pipeline and implementing new technologies and processes for continuous platform improvement. CLD, located in Framingham MA, is a global function, supporting research and early development projects at three Sanofi R&D Hubs (North America, France, Germany), and team members routinely work with colleagues at different sites.

The person in this role will work in a high-performing, fast-paced collaborative environment, ensure project goals and timelines are met, and help drive optimization for cell line production of biologics including antibodies and diverse, novel formats. Work will directly support development projects within Sanofi's pipeline. The position also provides the opportunity to work on global teams, contribute to operational excellence and other transversal initiatives, and have a direct impact on shaping our future cell line expression platforms.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Key Responsibilities

• Technical oversight and delivery of end-to-end cell line development work packages (as CLD Lead & Operator) to meet deliverables for preclinical and clinical development projects, including reports and presentations to stakeholders.
• Perform cell culture techniques for both pool and clone generation of expressive populations and cell lines. Work package also includes all other associated activities including PQ, banking, stability studies, copy number and transcript analysis.
• Actively engage and contribute to optimize cell line generation process towards using an automation-enabled high-throughput cell line platform.
• Drive innovation strategies for generating cell lines, to ensure “right first time” delivery of commercial-ready cell lines.
• Active engagement with Research functions ensuring smooth transition of projects and data exchange.
• Represent the CLD function on project teams and within Global CMC, making decisions for cell line activities and effectively communicating results, progress and plans. Active engagement and collaboration with global DS teams as the CLD representative.
• Compliance with all applicable regulations, ensure that work performed is conducted in a safe and compliant manner, ensure maintenance of proper records in accordance with SOPs and policies.
• Prepare and review documentation for regulatory submissions.

Basic Qualifications

• PhD (plus >4 yr experience) in a scientific discipline, or Master's degree in relevant discipline with >8yr of relevant experience.
• A degree in Biology, Cell Biology, Molecular Biology, Bioengineering, or a related discipline is preferred.
• Hands-on experience in mammalian cell line development (end-to-end) in a pharmaceutical or biotechnology setting, having CLD project leadership experience is a plus.
• Experience using automation platforms is highly desirable (Beckman, Tecan, Hamilton, Beacon, VIPS, etc.)
• Strong technical background and attention to detail.
• Self-motivated with excellent communication, organization and time-management skills.
• Demonstrated ability to work independently and in a highly collaborative environment and adhere to timelines.
• Experience with genetic characterization (gene copy number, transcript analysis) and CLD regulatory experience.
• Experience with leading projects, preparing regulatory agency submissions.

Preferred Qualifications

• Suspension mammalian cell culture experience (CHO cell culture) in a pharmaceutical or biotechnology setting.
• Experience with automation and/or high throughput technologies as applied to mammalian cell line generation and process optimization is highly preferred.
• Experience in mammalian gene expression systems, gene editing and/or 'omics technologies, experience in genetic characterization of cell lines, gene expression optimization.
• Deep working knowledge in the technical and quality CMC requirements for cell line development, and overall CMC space.
• Experience and working knowledge in high-throughput screening tools (bioreactors, analytics) for cell line selection.
• Flexibility and a willingness to expand skill set and responsibilities, and excel in a fast-paced highly cooperative team environment, ability to multitask, adaptability and positive attitude.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

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.