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CSCSL Behring

Director, Analytical Strategy(m/w/x)

Bern
Full-timeOn-siteSenior

Global analytical strategy development for biotherapeutics, including LC-MS/MS and immunogenicity testing. PhD or MSc with extensive experience required. Well-being support.

Requirements

  • PhD in analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field, or MSc with extensive experience
  • 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

Tasks

  • Develop and lead global analytical strategy
  • Provide scientific and regulatory guidance
  • Drive innovation in analytical technologies
  • Represent analytical function in cross-functional forums
  • Oversee development and validation of analytical methods
  • Ensure high-quality data generation for studies
  • Review and approve study designs and reports
  • Troubleshoot complex scientific challenges
  • Ensure compliance with global regulatory guidelines
  • Lead regulatory submission sections
  • Interface with regulatory agencies
  • Maintain inspection readiness and quality standards
  • Partner with clinical and translational teams
  • Support dose selection decisions
  • Manage external CROs and collaborators
  • Lead and mentor analytical scientists
  • Manage budgets and timelines
  • Build and scale analytical capabilities

Work Experience

  • 12 - 15 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • LC-MS/MS

Benefits

Mental Health Support

  • Well-being support
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