Job Title: Senior Associate Associate - Purification Process Development
About the Job: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.
Main 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
About you:Basic Qualifications
Education:- Bachelor's OR Master's degree in: Chemical Engineering, Biological/Life Sciences, or a related field
Experience:- 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
Preferred Qualifications
- 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
The salary range for this position is:
$75.000,00 - $108.333,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
