Associate Director Bioanalytics Mainz, Germany; Munich, Germany | full time | Job ID:9814 Contribution to implement biomarker testing strategy of multiple clinical trial projects, with a focus on bioligicals and ADC Selection of appropriate analytical technologies (including LC-MS, LBA, CBA, flow cytometry) in collaboration with R&D teams and departments of Translational Sciences and Clinical Pharmacology Contribute to the global selection and management of contractors in terms of their technical appropriateness and compliance with the respective regulatory requirements Responsibility for method transfer to or method development at external vendors (contract specialty labs) Responsibility for oversight of contract laboratories that perform feasibility studies, (further) development, and appropriate analytical validation of methods Degree (PHD preferred) in biochemistry, biology, chemistry pharmacy or equivalent A minimum of 5 years of experience in pharmaceutical or biotech industry Solid experience in assay development and analytical validation of methods for PK, ADA and biomarker testing In-depth knowledge of GCP/GLP as well as FDA and EMA regulatory requirements Ability to express complex issues in concise and clear language, very good English (written and spoken) and German (desired) Ability to identify problems and find solutions, as well as attention to detail It's our priority to support you: Your flexibility: flexible hours | vacation account Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential Your health and lifestyle: Company bike Your mobility: Job ticket | Deutschlandticket Your life phases: Employer-funded pension | Childcare