Senior Director, Analytical Strategy & Biopharma Programs

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

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