Associate Director, Analytical Strategy

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.

CSL’s world-class R&D organisation continues to evolve as a biotechnology leader by advancing high-quality science and technology across five therapeutic areas being Immunoglobulins, Haematology, Cardiovascular & Renal, Transplant & Immunology and Vaccines that will make a meaningful difference to the lives of patients with rare and serious diseases.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

• 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