The Associate Director, Analytical Strategy will lead the development and execution of analytical strategies to support biopharmaceutical development programs. This role requires deep molecular knowledge, expertise in analytical testing and molecule characterization, and a strong understanding of Quality by Design (QbD) principles and regulatory requirements. The successful candidate will drive analytical decision-making, ensure robust characterization of molecules, and support regulatory submissions with scientific rigor.
Tasks
- 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 to post-marketing)
- Drive innovation in analytical technologies, platforms, and workflows
- Represent analytical function in cross-functional governance and decision-making forums
- Oversee development, validation, and implementation of analytical methods (e.g., LC-MS/MS, ligand binding assays, biomarkers, immunogenicity)
- Ensure high-quality data generation for PK, PD, biomarker, and immunogenicity studies
- Review and approve analytical study designs, reports, and regulatory documentation
- Troubleshoot complex scientific and technical challenges
- Ensure compliance with global regulatory guidelines (FDA, EMA, ICH, GLP, GCP)
- Lead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA)
- Interface with regulatory agencies and respond to health authority queries
- Maintain inspection readiness and quality standards
- Partner with Clinical Pharmacology, DMPK, Toxicology, Biomarkers, and Clinical Operations
- Support translational strategy and dose selection decisions
- Manage external CROs, academic collaborators, and technology vendors
- Lead and mentor analytical scientists and project leaders
- Manage budgets, timelines, and resource allocation
- Build and scale analytical capabilities and infrastructure
Requirements
- 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 environments
- 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
Benefits
CSL offers benefits to support your well-being. Inclusion and belonging are at the core of the mission and culture, fostering innovation and a diverse workforce. CSL is an Equal Opportunity Employer and provides reasonable accommodation for individuals with disabilities during the application process.
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