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.
Responsibilities Include:
- 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.
Your experience and attributes:
- 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