Global Analytical Strategy Lead, Biotech

CSL Behring; Bern; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

CSL Behring is seeking two Associate Directors to design and oversee analytical strategies for product development and lifecycle management. You will guide cross-functional teams across regulatory, manufacturing and quality to ensure compliant, innovative analytical approaches for preclinical to commercial stages.

The roles demand doctoral-level expertise in analytical chemistry or related fields, with 8+ years in bioanalysis and a proven record in regulatory submissions and global programs.

Qualifikationen

• PhD in Analytical Chemistry or related field (or MSc with extensive experience).
• Typically 8+ years in bioanalysis within biotech, pharma, or CRO/CDMO environments.
• Deep expertise in analytical development, product specification testing, characterisation, and data analysis.
• Regulatory requirements and analytical validation standards knowledge.
• Leadership and strategic program experience in global matrix environments.
• Experience supporting regulatory submissions and health authority interactions.
• Excellent communication, able to present complex information to non-scientists.

Aufgaben

• Developing global analytical strategies for assigned products aligned with program and corporate goals.
• Provide scientific and regulatory guidance for analytical plans across all product development and LCM phases.
• Drive innovation in analytical technologies, platforms, and workflows.
• Review analytical study designs, reports, and regulatory documentation.
• Oversee development, validation, characterisation and implementation of analytical methods.
• Ensure high-quality data generation for product development and LCM programs.
• Troubleshoot complex scientific and technical challenges.
• Ensure compliance with global regulatory guidelines and interface with health authorities.
• Lead analytical sections of regulatory submissions (IND/CTA/NDA/BLA/MAA).
• Maintain inspection readiness and quality standards.
• Partner with Manufacturing, Quality, Research, CROs/CDMOs and external vendors.

Kenntnisse

Analytical chemistry

Leadership

Regulatory knowledge

Bioanalysis

Data analysis

Regulatory submissions

Communication

Ausbildung

PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field

Jobbeschreibung

CSL Behring is seeking two Associate Directors to design and oversee analytical strategies for product development and lifecycle management. You will guide cross-functional teams across regulatory, manufacturing and quality to ensure compliant, innovative analytical approaches for preclinical to commercial stages.

The roles demand doctoral-level expertise in analytical chemistry or related fields, with 8+ years in bioanalysis and a proven record in regulatory submissions and global programs.