(Senior) Scientist Bioanalytics (m/f/d)

Your mission We are seeking a highly motivated and scientifically driven (Senior) Scientist Bioanalytics to join our Bioanalytics team. You will contribute to the planning, execution and oversight of bioanalytical activities supporting clinical and non-clinical development programs.  This role involves close collaboration with Translational Research and Clinical Biomarkers, Clinical Pharmacology, Non-Clinical Safety, Clinical Operations, Clinical Development, Regulatory Affairs, and external laboratories. You will provide scientific and operational oversight of pharmacokinetic (PK), immunogenicity (ADA/NAb) and pharmacodynamic (PD) assays supporting drug development through non-clinical and clinical programs.   Key Responsibilities:   Bioanalytical Strategy & Program Support  Contribute to the development and execution of bioanalytical strategies within non-clinical and clinical development programs. Independently lead bioanalytical activities and proactively address scientific and operational challenges in a cross-functional environment. Support the selection, development, qualification/validation and implementation of PK, immunogenicity (ADA/ N A b ) , and PD assays. Provide scientific input to relevant clinical and non-clinical development documentation. Ensure bioanalytical activities are aligned with overall program objectives, scientific best practices, and applicable regulatory expectations. Support bioanalytical assay strategy discussions for non-clinical and clinical studies. Ensure bioanalytical activities are conducted in accordance with applicable GxP requirements and regulatory guidance. CRO and External Laboratory Oversight  Serve as the primary scientific contact for external bioanalytical laboratories and service providers. Support external vendor selection, qualification, and governance activities. Monitor laboratory performance, data quality, and timelines, and support issue resolution. Manage outsourced assay development, validation, and clinical and non-clinical sample analysis activities. Review and approve method validation reports, clinical and non-clinical sample analysis plans and reports, data transfer specifications, and other study-related documentation. Data Review and Interpretation  Evaluate bioanalytical results and provide scientific recommendations to support program decision-making. Support the integrated interpretation of PK, ADA, NAb , and PD data. Contribute to internal decision-making, cross-functional discussions, study reports, regulatory documentation, and scientific publications. Cross-Functional Collaboration  Act as a scientific interface between internal stakeholders, external consultants, and bioanalytical service providers, ensuring alignment on assay strategy, study execution, and interpretation of bioanalytical data. Work closely with Translational Research and Clinical Biomarkers, Clinical Pharmacology, Non-Clinical Safety, Clinical Operations, Clinical…