Analytical Strategy Leader - Biopharma

Biopharma Careers; Bern; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

CSL Behring seeks an Associate Director, Analytical Strategy to lead development and execution of analytical strategies across biopharmaceutical programs. This role requires deep molecular knowledge, regulatory insight, and QbD-driven decision making.

The successful candidate will oversee method development/validation (LC-MS/MS, biomarkers, immunogenicity), ensure data quality for PK/PD studies, and interact with global regulatory bodies to support IND/CTA/NDA submissions.

Qualifikationen

• PhD or MSc with extensive experience in bioanalysis and analytical development.
• 8+ years in bioanalysis within biotech, pharma, or CRO environments.
• Strong regulatory and analytical validation knowledge.

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

Kenntnisse

LC-MS/MS

Biomarker analysis

Immunogenicity testing

Regulatory knowledge

Leadership

Strategic program management

Ausbildung

PhD in analytical Chemistry / Pharmaceutical Sciences / Biochemistry (or MSc with extensive experience)

Tools

CRO management

Jobbeschreibung

CSL Behring seeks an Associate Director, Analytical Strategy to lead development and execution of analytical strategies across biopharmaceutical programs. This role requires deep molecular knowledge, regulatory insight, and QbD-driven decision making.

The successful candidate will oversee method development/validation (LC-MS/MS, biomarkers, immunogenicity), ensure data quality for PK/PD studies, and interact with global regulatory bodies to support IND/CTA/NDA submissions.