Mainz, Germany | full time | Job ID: 9853
Please note: This position is a one-year fixed-term contract.
Your main responsibilities are:
* 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
What you have to offer:
* 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
Your Benefits:
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
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 9853 (please always specify if you have any questions)
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