Analytical Strategy Lead — Biopharma & Regulatory

CSL; Bern; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

CSL, based in Switzerland, seeks an Associate Director of Analytical Strategy to shape and execute analytical strategies across development programs. The role requires deep molecular knowledge and a strong QbD/regulatory framework, driving analytical decisions and robust molecule characterization.

Responsibilities span strategic leadership, scientific oversight, regulatory compliance, cross-functional collaboration, and team leadership.

Qualifikationen

• PhD in analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field.
• 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.

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 → 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

LC-MS/MS

Biomarker testing

Immunogenicity testing

Regulatory knowledge

Analytical leadership

Ausbildung

PhD in analytical chemistry/related field

Tools

Instrumentation

Jobbeschreibung

CSL, based in Switzerland, seeks an Associate Director of Analytical Strategy to shape and execute analytical strategies across development programs. The role requires deep molecular knowledge and a strong QbD/regulatory framework, driving analytical decisions and robust molecule characterization.

Responsibilities span strategic leadership, scientific oversight, regulatory compliance, cross-functional collaboration, and team leadership.