Associate Director, Analytical Strategy (m/w/x)

CSL Plasma Inc.; Bern; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

CSL Behring seeks an Associate Director, Analytical Strategy to lead the development and execution of comprehensive analytical strategies supporting biopharmaceutical programs. The role requires deep molecular knowledge, analytical testing expertise, and a strong understanding of QbD and regulatory requirements.

You will drive analytical decision-making, oversee method development/validation (LC-MS/MS, biomarker assays), ensure robust data generation for PK/PD studies, and contribute to

Qualifikationen

• PhD in analytical chemistry, pharmaceutical sciences, biochemistry or related field (or MSc with extensive experience).
• 8+ years in bioanalysis within biotech, pharma, or CRO environments.
• Deep expertise in LC-MS/MS, ligand binding assays, biomarkers, and immunogenicity testing.
• Strong knowledge of regulatory requirements and analytical validation standards.
• Proven leadership and strategic program experience.
• Experience supporting regulatory submissions and health authority interactions.

Aufgaben

• Develop and lead the global analytical strategy aligned with program and corporate goals.
• Provide scientific and regulatory guidance for analytical plans across all development phases (discovery to post-marketing).
• Drive innovation in analytical technologies, platforms, and workflows.
• Represent analytical function in cross-functional governance and decision-making forums.
• Oversee development, validation, and implementation of analytical methods (e.g., LC-MS/MS, ligand binding assays, biomarkers, immunogenicity).
• Ensure high-quality data generation for PK, PD, biomarker, and immunogenicity studies.
• Review and approve analytical study designs, reports, and regulatory documentation.
• Troubleshoot complex scientific and technical challenges.
• Ensure compliance with global regulatory guidelines (FDA, EMA, ICH, GLP, GCP).
• Lead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA).
• Interface with regulatory agencies and respond to health authority queries.
• Maintain inspection readiness and quality standards.
• Partner with Clinical Pharmacology, DMPK, Toxicology, Biomarkers, and Clinical Operations Support translational strategy and dose selection decisions.
• Manage external CROs, academic collaborators, and technology vendors.
• Lead and mentor analytical scientists and project leaders.
• Manage budgets, timelines, and resource allocation.
• Build and scale analytical capabilities and infrastructure.

Kenntnisse

Analytical strategy

LC-MS/MS

Regulatory knowledge

Ausbildung

PhD in analytical Chemistry

MSc with extensive experience

Jobbeschreibung

Associate Director, Analytical Strategy (m/f/x)

The Associate Director, Analytical Strategy will lead the development and execution of analytical strategies to support biopharmaceutical development programs. This role requires deep molecular knowledge, expertise in analytical testing and molecule characterization, and a strong understanding of Quality by Design (QbD) principles and regulatory requirements. The successful candidate will drive analytical decision-making, ensure robust characterization of molecules, and support regulatory submissions with scientific rigor.

Main Responsibilities & Accountabilities

Strategic Leadership

• Develop and lead the global analytical strategy aligned with program and corporate goals


• Provide scientific and regulatory guidance for analytical plans across all development phases (discovery to post-marketing)


• Drive innovation in analytical technologies, platforms, and workflows


• Represent analytical function in cross-functional governance and decision-making forums

Scientific Oversight

• Oversee development, validation, and implementation of analytical methods (e.g., LC-MS/MS, ligand binding assays, biomarkers, immunogenicity)


• Ensure high-quality data generation for PK, PD, biomarker, and immunogenicity studies


• Review and approve analytical study designs, reports, and regulatory documentation


• Troubleshoot complex scientific and technical challenges

Regulatory & Compliance

• Ensure compliance with global regulatory guidelines (FDA, EMA, ICH, GLP, GCP)


• Lead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA)


• Interface with regulatory agencies and respond to health authority queries


• Maintain inspection readiness and quality standards

Cross-Functional Collaboration

• Partner with Clinical Pharmacology, DMPK, Toxicology, Biomarkers, and Clinical Operations Support translational strategy and dose selection decisions


• Manage external CROs, academic collaborators, and technology vendors

Leadership & Management

• Lead and mentor analytical scientists and project leaders


• Manage budgets, timelines, and resource allocation


• Build and scale analytical capabilities and infrastructure

Qualifications & Experience Requirements

• PhD in analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field (or MSc with extensive experience)


• Typically 8+ years in bioanalysis within biotech, pharma, or CRO environments


• Deep expertise in LC-MS/MS, ligand binding assays, biomarkers, and immunogenicity testing


• Strong knowledge of regulatory requirements and analytical validation standards


• Proven leadership and strategic program experience


• Experience supporting regulatory submissions and health authority interactions

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

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