Join a global biotech leader and play a critical role in ensuring the integrity, compliance, and long-term stewardship of clinical samples that support the development of life-changing therapies. Reporting to the Director, Bioanalysis, Immunogenicity and Biomarkers, this role sits within the Clinical Bioanalytics and Biomarker team and is responsible for managing regulatory-compliant short- and long-term storage solutions across the Global R&D portfolio.
The Opportunity
As Senior Scientist, Sample Management, you will lead and coordinate sample management activities across non-clinical and clinical development programs. You will bring strong scientific expertise together with a deep understanding of regulatory and quality requirements to ensure samples are managed, tracked, stored, transferred, and curated in accordance with applicable global standards. This involves internal sample receipt, accessioning and disposal as well as sample reconciliation and long-term storage management until the end of the sample life-cycle.
Working within a highly collaborative matrix environment, you will partner with internal stakeholders including Clinical Bioanalysis and Biomarker, Non-clinical, Clinical Operations, Outsourcing, and Contract Operations teams, as well as external laboratories, CROs, and long-term storage providers to support successful project delivery while maintaining the highest levels of compliance and operational excellence.
Key Responsibilities
- Lead and coordinate compliant short- and long-term storage of clinical samples supporting the Global R&D portfolio
- Ensure the timely support of development programs from non-clinical research through all phases of clinical development.
- Responsible for internal sample lifecycle management at CSL Melbourne including sample receipt, accessioning, storage, retrieval, transfer and disposal of all non-clinical and clinical samples at the internal facility
- Oversee the reconciliation, curation, transfer, long-term storage, and disposal of critical clinical samples across internal and external facilities.
- Ensure sample management activities are conducted in accordance with OECD GLP, ISO 17025, GCP, and relevant global regulatory requirements.
- Support internal and external audits, inspections, accreditation activities, and regulatory interactions.
- Collaborate with Clinical Bioanalysis and Biomarkers as key stakeholders to align resources, project timelines, priorities, and risk management activities around all samples.
- Partner with Clinical Operations, Outsourcing, Contract Operations teams, and external vendors to ensure appropriate handling and storage of clinical samples.
- Communicate project progress, risks, issues, and outcomes effectively to stakeholders across global cross-functional teams.
- Foster strong working relationships with internal stakeholders, external laboratories, storage providers, and industry partners to support successful project outcomes.
About You
You are a scientifically driven professional with a passion for quality, compliance, and operational excellence. You thrive in complex, collaborative environments and enjoy partnering with diverse stakeholders to solve challenging problems.
Qualifications & Experience
- MSc, PhD, or equivalent postgraduate qualification in Immunology, Life Sciences, Sample Management, or a related discipline.
- Minimum 3 years' experience in the biotechnology, pharmaceutical, CRO, or related research environment.
- Demonstrated experience managing biological or clinical samples within regulated environments.
- Strong knowledge of ISO 17025, OECD GLP, GCP, and applicable FDA/EMA regulatory requirements.
- Proven ability to work effectively within global, cross-functional, and multicultural teams.
- Excellent communication, stakeholder management, and vendor relationship skills.
- A track record of scientific achievement and continuous improvement.
Why Join Us?
- Contribute to innovative programs that improve patients' lives worldwide.
- Work alongside leading scientists and industry experts in a highly collaborative environment.
- Gain exposure to global R&D programs and cutting-edge technologies.
- Be part of an organisation committed to scientific excellence, innovation, and continuous learning.
Applications Close on July 14, 2026
