Senior Analytical Strategy Lead, Biotech & Gene Therapy

CSL Vifor; Bern; Hybrid; CHF 180.000 - 280.000; Vollzeit

Zusammenfassung

CSL Vifor seeks two Associate Director level scientists to design and oversee analytical strategies supporting product development and lifecycle management. The roles ensure robust, compliant analytical approaches across pre-clinical and clinical development as well as LCM for commercial products.

These senior leaders will have global reach, with potential placements at Bern or other northern hemisphere sites, and will interface with regulatory agencies, CROs/CDMOs, and external partners 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/CDMO environments.
• Strong knowledge of regulatory requirements and analytical validation standards.

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.
• Lead analytical sections of regulatory submissions and maintain inspection readiness.

Kenntnisse

Analytical development

Bioanalysis

Regulatory strategy

Leadership

Regulatory submissions

Ausbildung

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

MSc with extensive experience

Jobbeschreibung

CSL Vifor seeks two Associate Director level scientists to design and oversee analytical strategies supporting product development and lifecycle management. The roles ensure robust, compliant analytical approaches across pre-clinical and clinical development as well as LCM for commercial products.

These senior leaders will have global reach, with potential placements at Bern or other northern hemisphere sites, and will interface with regulatory agencies, CROs/CDMOs, and external partners to