Global Associate Director, Analytical Strategy

CSL Plasma Inc.; Bern; Hybrid; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

CSL Behring seeks two Associate Directors of Analytical Strategy to design and oversee analytical strategies for multiple products, spanning preclinical to lifecycle management, with global scope and potential Bern or other northern hemisphere sites.

You will guide analytical development, validation, and data interpretation, ensuring regulatory compliance and high-quality data across programs including gene therapies where applicable.

Qualifikationen

• 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/CDMO environments
• Deep expertise in analytical development, product specification testing, characterisation, and data analysis
• Demonstrated knowledge of regulatory requirements and analytical validation standards
• Proven leadership and strategic program experience ideally in a global matrix environment
• Experience supporting regulatory submissions and health authority interactions
• Excellent communication skills including presenting complex information to non-scientific stakeholders
• Experience with gene therapy products desirable, but not essential

Aufgaben

• Develop 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 (FDA, EMA, ICH, GMP) and interface with regulatory agencies
• Lead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA)
• Maintaining inspection readiness and quality standards
• Partnering with internal stakeholders across Manufacturing, Quality Control, Quality Assurance, Research and external partners such as CROs/CDMOs, academic collaborators and technology vendors

Kenntnisse

Analytical strategy

Regulatory knowledge

Leadership

Bioanalysis

Communication

Ausbildung

PhD in Analytical Chemistry or related field

MSc with extensive experience

Jobbeschreibung

CSL Behring seeks two Associate Directors of Analytical Strategy to design and oversee analytical strategies for multiple products, spanning preclinical to lifecycle management, with global scope and potential Bern or other northern hemisphere sites.

You will guide analytical development, validation, and data interpretation, ensuring regulatory compliance and high-quality data across programs including gene therapies where applicable.