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

Remotely; Martinsried; Hybrid; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Flexible working arrangements

On-site collaboration

Permanent contract with benefits

Zusammenfassung

CatalYm in Martinsried near Munich seeks a (Senior) Scientist Bioanalytics to drive PK, ADA/NAb and PD bioanalytical activities across clinical and non-clinical programs. The role blends scientific leadership with cross-functional collaboration to deliver robust data and regulatory-ready reports.

You will oversee assay development, qualification/validation, and external laboratory partnerships, ensuring GxP compliance and timely study execution in a fast-paced biotech environment.

Qualifikationen

• Ph.D., M.Sc., or equivalent in Immunology, Biochemistry, Pharmacology, Pharmaceutical Sciences, Life Sciences, or related discipline.
• 2-5 years of industry experience in bioanalysis within biotech/pharma/CRO.
• Experience with PK, ADA, NAb and PD assay development and sample analysis.
• Knowledge of FDA, EMA and ICH bioanalytical guidelines.
• Experience managing external laboratories and outsourced studies.

Aufgaben

• Develop and execute bioanalytical strategies for non-clinical and clinical programs.
• Independently lead bioanalytical activities and address scientific/operational challenges.
• Oversee PK, ADA/NAb, and PD assays, including development, validation, and implementation.
• Provide scientific input to regulatory documents and study reports.
• Ensure compliance with GxP and regulatory guidance in all bioanalytical activities.

Kenntnisse

Bioanalytics

Assay development

External lab management

Data interpretation

Regulatory knowledge

Ausbildung

PhD in Immunology/Biochemistry/Pharmacology

MSc in Life Sciences or related discipline

Tools

LC-MS

Data analysis software

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.

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!