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 Development, Regulatory Affairs, and external subject matter experts and consultants supporting CatalYm's development programs.
• Present bioanalytical strategies, results, and recommendations to project teams and management.