Senior Associate Scientist Purification Process Development

Sanofi•Waltham, MA

1d•Onsite

About The Position

The Genomic Medicine Unit (GMU) in Sanofi is responsible for the design and optimization of viral vector manufacturing processes and platforms. This organization encompasses vector and cell line engineering, upstream and downstream process development, analytics, and clinical manufacturing support. The GMU purification process development group is responsible for the development of AAV and non-viral vector processes and for supporting viral vector purification from next-generation production platforms to enable high-dose gene therapy programs. The Senior Research Associate (SRA) – Downstream 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 non-viral purification development, scale-up and manufacturing, and technology transfer. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Requirements

Bachelor's OR Master's degree in: Chemical Engineering, Biological/Life Sciences, or a related field
Bachelor's holders: 2+ years of experience in laboratory or related settings
Master's holders: 6+ months of experience in laboratory or related settings
Academic or research experience will be considered.
Knowledge of purification technologies and operations such as: Depth filtration, AKTA, automated protein purification chromatography, tangential flow filtration, UF/DF, virus clearance and inactivation or filtration unit operations at various scales.
Understanding of chromatography principles and separation methods
Technical report writing skills
Ability to learn and perform viral vector analyses using new tools and techniques
Good laboratory practices (GLP), including detailed lab notebook documentation

Nice To Haves

Experience specifically with AAV and/or non-viral vector purification
Knowledge of analytical tools: spectrophotometry, ELISA, HPLC, and SDS-PAGE
Familiarity with Quality by Design principles and ability to apply Design of Experiments (DOE) to downstream development
Understanding of virus clearance study design and execution
Experience with large-scale manufacturing unit operations
Experience with process technology transfers, gap analyses, and risk assessments
Biosafety Level 2 lab experience
Ability to work under minimal supervision
Strong organizational and communication skills (verbal and written)
Ability to build cross-functional relationships and represent the team in multi-functional meetings
Collaborative, team-oriented mindset
Ability to stand and work with lab bench equipment for extended periods

Responsibilities

Support to develop, 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 / 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
Support 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
Self-motivated and display sound technical judgement
Build a culture of support and collaboration among colleagues