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