Associate Director, Global Analytical Strategy

CSL; Melbourne; On-site; AUD 180,000 - 260,000; Full time

Job summary

CSL is seeking two Associate Director level scientists to design and oversee analytical strategies for product development and lifecycle management, with global reach and possible base at Melbourne. The role ensures robust, compliant analytical approaches across pre-clinical through commercial operations.

Key responsibilities include leading regulatory submissions, validation, data quality, and cross-functional collaboration with Manufacturing, Quality, and external partners; global regulatory

Qualifications

• 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/CDMO environments
• Deep expertise in analytical development, product specification testing, characterisation, and data analysis.
• Demonstrated knowledge of regulatory requirements and analytical validation standards.
• Proven leadership and strategic program experience ideally in a global matrix environment.
• Experience supporting regulatory submissions and health authority interactions.
• Excellent communication skills including presenting complex information to non-scientific stakeholders.
• Experience with gene therapy products desirable, but not essential

Responsibilities

• Developing 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
• Reviewing 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.
• Partner with Manufacturing, Quality Control, Quality Assurance and external partners such as CROs/CDMOs.
• Collaborate with academic collaborators and technology vendors.

Skills

Leadership

Regulatory submissions

Bioanalysis

Analytical development

Data analysis

Regulatory knowledge

Communication

Gene therapy

Education

PhD in Analytical Chemistry

MSc with extensive experience

Job description

CSL is seeking two Associate Director level scientists to design and oversee analytical strategies for product development and lifecycle management, with global reach and possible base at Melbourne. The role ensures robust, compliant analytical approaches across pre-clinical through commercial operations.

Key responsibilities include leading regulatory submissions, validation, data quality, and cross-functional collaboration with Manufacturing, Quality, and external partners; global regulatory