Scientist, Tech Ops (GMP Testing)

CSL; City of Melbourne; On-site; AUD 90,000 - 120,000; Full time

Job summary

CSL Behring in Melbourne seeks an experienced Scientist to join the GMP Analytical Testing team for a 12-month fixed-term period. You will plan and execute GMP analytical testing, support stability programs and assay qualification, and contribute to technology transfer with strong data integrity.

You will collaborate with Quality Assurance and project teams, manage laboratory activities with ownership, and maintain inspection-ready operations using LIMS, ELN, and instrument control software.

Qualifications

• Bachelor’s or postgraduate qualification in analytical biochemistry, chemistry, molecular and cellular biology, pharmaceutical sciences or a related discipline.
• 3+ years’ relevant laboratory experience in biotechnology, pharmaceutical or biopharmaceutical industries.
• Hands-on experience with protein biochemistry and/or bioanalytical techniques (HPLC, CE-SDS, icIEF, ELISA, UV-Vis).
• GMP or regulated laboratory experience with data integrity and compliant documentation.
• Experience using LIMS, ELN, instrument control software and MS Office.
• Strong organisational and stakeholder-management skills.

Responsibilities

• Perform GMP analytical testing to support batch release and stability programs.
• Execute and review analytical experiments using protein biochemistry and bioanalytical methods.
• Support stability studies including protocol development, scheduling, sample management and reporting.
• Contribute to quality system activities (deviations, CAPAs, investigations, change controls, risk assessments).
• Assist assay qualification and technology transfer activities with data analysis and reporting.
• Prepare GMP documentation and maintain data packages and technical reports.
• Collaborate with QA, project teams and external partners to achieve timelines.
• Maintain inspection-ready laboratory operations and data integrity using LIMS/ELN and relevant software.

Skills

Protein biochemistry

Bioanalytical techniques

GMP experience

Data integrity

Stakeholder management

LIMS familiarity

ELN proficiency

Instrument control software

Microsoft Office

Education

Bachelor’s or postgraduate qualification in analytical biochemistry, chemistry, molecular and cellular biology, pharmaceutical sciences or related discipline

Tools

LIMS

ELN

Instrument control software

Microsoft Office

Job description

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

About CSL Behring

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. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

You Belong at CSL

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.

Equal Opportunity Employer CSL is an Equal Opportunity Employer.

CSL is an Equal Opportunity Employer.

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