Scientist, GMP Testing

About the role

We are seeking an experienced Scientist to join our Melbourne-based GMP Analytical Testing team on a 12-month fixed-term basis. In this laboratory-based role, you will support CSL Technical Operations through GMP analytical testing, stability study support, assay qualification and analytical technology transfer. You will plan and execute routine and non-routine laboratory activities, evaluate and review analytical data, investigate technical issues and prepare high-quality scientific and GMP-compliant documentation.

Working within a collaborative, cross-functional environment, you will manage assigned activities with a high level of ownership while partnering with Quality Assurance, project teams, analytical groups and other internal and external stakeholders to deliver accurate, reliable and timely outcomes.

Key responsibilities

Perform routine and non-routine GMP analytical testing to support batch release and stability programs.

Execute, evaluate and review analytical experiments using a range of protein biochemistry and bioanalytical techniques, ensuring data accuracy, integrity and compliance with GMP requirements.

Support stability studies through protocol development, study scheduling, sample management, testing and reporting activities.

Coordinate and contribute to quality system activities associated with analytical testing and stability programs, including deviations, change controls, investigations, CAPAs and risk assessments.

Support assay qualification and technology transfer activities, including protocol development, experimental execution, data analysis and reporting.

Prepare, review and maintain GMP documentation, including test procedures, SOPs, protocols, qualification documents, data packages and technical reports.

Collaborate effectively with Quality Assurance, project teams, analytical groups and external partners to deliver project objectives and timelines.

Maintain inspection-ready laboratory operations through equipment maintenance, inventory management, housekeeping and compliance with safety and quality requirements.

Utilise electronic laboratory systems, including LIMS, ELN and instrument control software, to manage analytical data and documentation in accordance with data integrity principles.

Contribute to continuous improvement initiatives, new technology implementation, staff training and the ongoing development of GMP analytical capabilities within the team.

About you

Bachelor's or postgraduate qualification in analytical biochemistry, chemistry, molecular and cellular biology, pharmaceutical sciences or a related discipline, with 3+ years' relevant laboratory experience in the biotechnology, pharmaceutical or biopharmaceutical industry.

Hands-on experience with protein biochemistry and/or bioanalytical techniques including (but not limited to) HPLC, CE-SDS, icIEF, ELISA, UV-Vis spectroscopy or related analytical methods.

Experience working within GMP or other regulated laboratory environments, with a strong understanding of quality systems, data integrity and compliant documentation practices.

Understanding of operational and quality requirements for analytical testing, stability study management, assay qualification and verification activities.

Demonstrated ability to generate, analyse, review and communicate high-quality scientific data, including troubleshooting and investigation of technical issues.

Experience using laboratory electronic systems and software, including LIMS, ELN, instrument control software and Microsoft Office applications.

* Exceptional organisational, communication and stakeholder-management skills, with a proactive, adaptable and results-driven approach to ownership, collaboration and delivery.

Applications Close on 25 October, 2026