Associate Director, Analytical Strategy
CSL
Summary
CSL is seeking two Associate Director level scientists to design and oversee analytical strategies that support product development and lifecycle management (LCM). The Associate Director Analytical Strategy ensures the deployment of robust, compliant, and innovative analytical approaches across pre-clinical and clinical development as well as LCM for commercial products. These are key senior scientific and strategic leadership roles supporting a diverse portfolio of recombinant protein and gene therapy products from early development, through licensure and ongoing commercial operations. These positions have global reach and could be based at one of our northern hemisphere sites (Bern, Marburg, King of Prussia or Waltham).
Job description
Key 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
- Partnering with internal stakeholders across Manufacturing, Quality Control, Quality Assurance, Research and external partners such as CROs/CDMOs, academic collaborators and technology vendors
Your Profile
- 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
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/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
Company overview
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.