Senior Scientist I, Biological Analyses

Sanofi

The appointed candidate will be responsible for developing, validating and implementing at the bench, robust and sensitive analytical assays, mainly for projects in clinical development
He/she should perform analyses in accordance with study protocols and standard operating procedures. Ensures scientific quality of work performed
He/she should demonstrate knowledge and skills in solving scientific issues and troubleshooting, as well as proposing innovative analytical assays
He/she will be the main point of contact as responsible scientist, interacting with the project team to understand the needs and ensure that study validation or analyses are conducted in a timely manner with the highest quality standard, as well as providing scientific support
He/she will work considering timelines, project milestones, as well as preparing reports suitable for regulatory submission, mainly to support clinical development
He/she will work with outsourcing operational group and CROs to transfer and monitor external analyze efforts, when necessary
The candidate in this position will support multiple projects and collaborate transversally with colleagues across the globe, for example as project team member coordinating all Laboratory Sciences activities that are not limited to Bioanalyses

The ideal candidate would be a scientist with a minimum of 5 years of hands-on experience in developing, validating and implementing Ligand Binding Assays in a pharmaceutical or biotechnology environment

Strong experience in assay development, validation and implementation of LBA
Strong expertise in immunogenicity assessment:
- ADA assay development and validation
- NAb assay design and implementation
- Multi-tiered testing strategy
- Cut-point determination and statistical analysis
Strong expertise using LBA technologies, such as: ELISA, MSD, Gyrolab, ELLA, SIMOA, and other immunoassay platforms
Proactively tracks technology trends to continuously evolve and modernize the platform by adopting new technologies
Digital: motivated to explore and implement AI solutions in bioanalyses. Knowledge or experience using laboratory software such as Benchling or LIMS WATSON would be a plus
Experience in the regulatory landscape related to GCP/GCLP knowledge, as well as in relevant guidance documents (FDA/EMA/ICH, etc.) would be considered as a plus

Strong team spirit, understanding team dynamic and support colleagues
Team player with a mindset to participate in the laboratory life, enthusiastic, proactive, promote knowledge sharing, accurate in execution and reporting
Innovative, motivated, and autonomous
Very good communication skills (many meetings/interactions in challenging contexts)
Rigorous and detail-oriented with strong commitment to quality
Well organized, able to work in a complex fast-changing environment