(Senior) Scientist Bioanalytics (m/f/d)
Catalym
Location not stated
Senior
2 weeks ago
€70,000 – €90,000 / year
- ICH
2 weeks ago
Not enough detail in this posting to match
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/NAb), 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 applicableGxP requirements and regulatory guidance.
- 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.
- 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.
- 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 supportingCatalYm's development programs.
- Present bioanalytical strategies, results, and recommendations to project teams and management.
- Ph.D., M.Sc., or equivalent degree in Immunology, Biochemistry, Pharmacology, Pharmaceutical Sciences, Life Sciences, or a related discipline.
- 2-5 years of industry experience in bioanalysis within the biotechnology, pharmaceutical, or CRO environment, including experience supporting bioanalytical programs and working with external laboratories and service providers.
- Experience with PK, ADA,NAb, and PD assay development, validation, and sample analysis in non-clinical and/or clinical studies.
- Knowledge of applicable FDA, EMA, and ICH bioanalytical and immunogenicity guidelines.
- Experience managing external laboratories and outsourced studies.
- Knowledge of biologics, immunology,oncology and immuno-oncology is preferred.
- The opportunity to contribute to the clinical development of a promising, innovative cancer therapy.
- An operational role at the interface of translational research, clinical biomarkers, clinical operations, and clinical bioanalytics.
- A collaborative and purpose-driven team environment.
- Flexible working arrangements, including partial remote work while maintaining regular on-site collaboration.
- A secure, permanent employment contract with competitive compensation and attractive employee benefits.
(Senior) Scientist Bioanalytics (m/f/d) · Catalym