Analytical Strategy Lead – Global Biotech

CSL Plasma Inc.; Bern; Hybrid; CHF 180,000 - 240,000; Full time

Job summary

CSL Plasma Inc. is seeking two Associate Director level scientists to design and oversee analytical strategies that support product development and lifecycle management.

You will lead robust, compliant analytical approaches across pre-clinical, clinical development and commercial operations on recombinant proteins and gene therapies. The roles require PhD with 8+ years in bioanalysis, demonstrated leadership, and experience interfacing with health authorities.

Qualifications

• 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.
• Leadership and strategic program experience in a global matrix environment; regulatory submissions experience.

Responsibilities

• 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, responding to health authority queries.
• 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

Skills

Leadership

Strategic program management

Regulatory knowledge

Communication skills

Regulatory submissions experience

Education

PhD in Analytical Chemistry or related field

MSc with extensive experience

Job description

CSL Plasma Inc. is seeking two Associate Director level scientists to design and oversee analytical strategies that support product development and lifecycle management.

You will lead robust, compliant analytical approaches across pre-clinical, clinical development and commercial operations on recombinant proteins and gene therapies. The roles require PhD with 8+ years in bioanalysis, demonstrated leadership, and experience interfacing with health authorities.