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

CatalYm GmbH; Krailling; Hybrid; EUR 80.000 - 120.000; Vollzeit

Benefits dieser Stelle

Flexible work

Permanent contract

Competitive pay

Employee benefits

Zusammenfassung

CatalYm is seeking a (Senior) Scientist Bioanalytics to join our Bioanalytics team in Martinsried near Munich. You will contribute to planning, execution and oversight of bioanalytical activities supporting clinical and non-clinical development programs.

This role involves collaboration with Translational Research and Clinical Biomarkers, Clinical Pharmacology, Non-Clinical Safety, Clinical Operations, Regulatory Affairs, and external laboratories.

Qualifikationen

• Ph.D., M.Sc., or equivalent in Immunology, Biochemistry, Pharmacology, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• 2–5 years of industry experience in bioanalysis with biotechnology/pharma/CRO environments.
• Experience with PK, ADA, NAb, and PD assay development, validation, and sample analysis in non-clinical and/or clinical studies.
• Knowledge of 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.

Aufgaben

• Develop and execute bioanalytical strategies for non-clinical and clinical development programs.
• Independently lead bioanalytical activities and address scientific and operational challenges across cross-functional teams.
• Support selection, development, qualification/validation and implementation of PK, ADA/NAb, and PD assays.
• Provide scientific input to clinical and non-clinical development documentation.
• Ensure bioanalytical activities align with program objectives, science best practices, and regulatory expectations.
• Support bioanalytical assay strategy discussions for non-clinical and clinical studies.
• Ensure bioanalytical activities meet GxP requirements and regulatory guidance.
• Serve as scientific interface for external labs and vendors; oversee partnerships.

Kenntnisse

Bioanalysis

PK assays

ADA/NAb

PD assays

External labs

Immunology

Ausbildung

PhD or MSc in Life Sciences

Jobbeschreibung

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.

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/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 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.

Your profile

• 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.

Why us?

We offer:

• 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.

About Us

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!