Our Team:
We are seeking a Lab Head and Expert in Bioanalysis to join our Biomarkers & Clinical Bioanalysis (BCB) global department within the Translational Medicine and Early Development unit of Sanofi R&D. BCB enables the first time a new drug comes to patients with its entrepreneurial and cutting edge bioanalysis team. 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 an Expert in Bioanalysis the candidate will contribute to the global BCB department’s innovation and standardization activities.
Main responsibilities:
- Develop and implement different formats of Ligand Binding Assay (LBA) technologies for biomarker, immunogenicity and biomolecule pharmacokinetic assays for clinical studies
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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
- Introduce novel assay formats and techniques in the different BCB scientific domains
- 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, Health Authorities, etc.)
- 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, Gyros, Mesoscale Discovery, Quanterix and others
- Understanding of various biomolecule LBA assays formats (Free versus Total versus Active Assay formats)
- Knowledge in immunology and associated biomarker assays and knowledge in 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
- Baisc knowledge in digital solutions for data analysis and laboratory documentation (Microsoft Office, Thermo Fisher Watson LIMS system, Electronic Lab Notebook solutions by IDBS or Benchling)
- Leadership skills and the 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)
Pursue progress, discover extraordinary
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, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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