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. 

This job offer is accessible to all, regardless of gender.                                                                                                                                          

Job title: Senior scientist in Biological Analyses

• Job location in Montpellier (France)
• No travel will be expected in this job description, except to attend congress
• Job type: Permanent

About the job

About Sanofi: 

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. 

Our Team:

We are seeking a senior scientist to join the Biological Analyses group in Montpellier, within Laboratory Sciences (LabSci), a global department within the Translational Medicine Unit (TMU) of Sanofi.

LabSci plays a critical role in drug development, contributing to bioanalytical strategy and providing translational support from nonclinical to clinical studies. The Biological Analysis laboratory in Montpellier is part of a hybrid bioanalytical platform that includes a Mass Spectrometry laboratory.

The laboratory develops and implements ligand binding assay (LBA) methods to support immunogenicity studies, pharmacokinetic analysis, and biomarker monitoring for large molecule therapeutics. These activities primarily support clinical projects in Sanofi's portfolio in accordance with Good Clinical Laboratory Practices (GCLP).

Main responsibilities:

• 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

About you

Experience:

• 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

Technical skills:

• 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 softwares 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

Soft skills:

• 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 exe