The Opportunity

At CSL, we are driven by our promise to save lives and protect the health of people around the world. We are seeking a highly motivated and scientifically accomplished Senior Scientist, Bioanalytical Compliance to join our Clinical Bioanalytics, Immunogenicity and Biomarkers team.

This is a unique opportunity to combine deep scientific expertise with regulatory compliance leadership, supporting bioanalytical activities across the full drug development lifecycle. You will play a critical role in ensuring our accredited laboratory facility meets global regulatory standards while contributing to innovative non-clinical and clinical development programs that advance life-changing therapies.

Your Responsibilities

Reporting to the Director, Bioanalysis, Immunogenicity and Biomarkers, you will provide scientific leadership and compliance expertise across Bioanalysis and Biomarker activities. Specifically, you will:

- Lead and support compliance activities within our accredited bioanalytical laboratory, ensuring alignment with OECD GLP, ISO 17025, GCP and applicable regulatory requirements.
- Support laboratory accreditation, audits, inspections and quality management activities, including CAPAs, deviations, investigations and continuous improvement initiatives.
- Provide scientific and compliance expertise for bioanalytical, biomarker and immunogenicity programs from preclinical research through clinical development.
- Partner with cross-functional teams to deliver project milestones, manage priorities, identify risks and ensure high-quality scientific outcomes.
- Contribute to assay development, validation strategies, experimental design,



data analysis and scientific reporting while maintaining strong data integrity standards to ensure bioanalytical compliance.
- Build effective relationships with internal stakeholders, external partners, vendors and regulatory bodies to support program delivery.
- Promote innovation by identifying and applying emerging technologies, automation, digital solutions and AI-enabled approaches within regulated laboratory environments.
- Represent CSL within the broader scientific community through engagement with industry forums, conferences and collaborative networks.

About You

You are an experienced scientist who brings:

- Postgraduate qualification (preferably MSc or PhD) in Immunology, Biomedical Sciences, Life Sciences or a related discipline.
- Minimum 3 years' relevant industry experience or equivalent academic research experience.
- Demonstrated experience supporting bioanalytical, biomarker or immunogenicity programs within a regulated workplace.
- Strong track record of scientific achievement and problem solving.
- Experience working in cross-functional and global matrix teams.
- Working knowledge of OECD GLP, ISO 17025, GCP and relevant FDA/EMA regulatory guidelines.
- Experience with laboratory quality systems, audits, inspections and accreditation requirements.
- Understanding of bioanalytical assay development, validation and clinical sample analysis.
- Knowledge of regulated data management and data integrity principles.
- Excellent written and verbal communication skills.
- Strong stakeholder engagement and influencing capability.
- Effective project planning and organisational skills.
- Ability to navigate complexity and balance compliance requirements with scientific innovation.

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📌 Senior Scientist, Bioanalytical Compliance (Melbourne)
🏢 CSL
📍 Melbourne