Bench Scientist - all genders (limited for 24 months)

About the job

Our Team:

We are seeking a Bench Scientist to join our Biomarkers & Clinical Bioanalysis (BCB) global department within the Translational Medicine and Early Development unit of Sanofi R&D. With its entrepreneurial and cutting-edge bioanalytic team, BCB enables a new drug to reach patients for the first time. The position will be located in Frankfurt, Germany and will be responsible to develop and implement innovative assay technologies to monitor biomarkers, pharmacokinetics (PK) and immunogenicity of biomolecule projects. The job includes to represent the BCB department in international project teams to jointly develop and implement the teams’ biomarker, immunogenicity and biomolecule PK assay strategy. As a Bench Scientist the candidate will contribute to the global BCB department’s innovation and standardization activities.

Main responsibilities:

• Develop and conduct different formats of Ligand Binding Assay (LBA) technologies for biomarker, immunogenicity and biomolecule pharmacokinetic assays for clinical studies
• Ensure the regulatory compliance (Good Clinical Laboratory Practices, GCLP) of bioanalytical methods to meet critical deliverables, including key results for human clinical trials
• Coach and train the technicians lab crew and provide scientific support to their assay development and clinical study samples measurements under GCLP regulations
• Act as responsible scientist to author and review Bioanalytical Method Validation Plans, Method Descriptions, Method Validation Reports, Clinical Bioanalytical Study Plans and Clinical Bioanalytical Study Reports
• Analyze, interpret and trouble-shoot biomarker, immunogenicity and biomolecule PK assay data and author corresponding reports
• Contribute to the global BCB department’s innovation and standardization of LBA technologies; adapt Business Technical Documentations (BTD) and Standard Operating Procedures (SOP) to EMA, FDA, ICH and OECD guidelines
• Drive the analytical science and digital solutions advancement of the laboratory equipment and way of working
• Interact with partners, internally (Site Quality Operations, Digital, Project Operations, Clinical Study Teams, etc.), and externally (Contract Research Organizations)
• Act as BCB representant in international project teams to jointly develop and implement the teams’ biomarker, immunogenicity and biomolecule PK assay strategy

About you

• PhD in life sciences (biology, biochemistry, cell biology, immunology, medicine) with experience in various ligand binding assay (LBA) technologies like ELISA, Mesoscale Discovery (MSD), Gyros, Quanterix and others
• Deep understanding of antibody-related science and technologies
• Knowledge in immunology and associated pharmacokinetic (PK, free vs total), biomarker and immunogenicity assay formats (Anti Drug Antibody, Neutralizing Antibody Assays) would be a plus
• Basic know-how in requirements of regulatory authorities for GCLP and the associated Quality Assurance framework would be a plus
• Basic knowledge in digital solutions for data analysis and laboratory documentation (Microsoft Office, Thermo Fisher Watson LIMS system, Electronic Lab Notebook solutions e.g. Benchling)
• Ability to integrate into international multi-functional global team of scientists and presenting results to scientific teams and stakeholders
• Strong interpersonal communication and presentation skills
• Result oriented and well-organized team player in an agile environment
• Fluency in German and English (both written and spoken)

• #LI-Onsite

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!