Job Description

The Opportunity

We are hiring a Scientist to join our Pilot Scale Operations team at our Melbourne site. You will contribute to team activities associated with the development, transfer/scale-up and subsequent manufacture of investigational medicinal recombinant protein products following both GSP and GMP. These activities will be conducted in new pilot-scale facilities recently built at our CSL Melbourne site.

You will have a high level of technical expertise in pilot scale manufacturing process design, development, optimisation, operation and troubleshooting. You will have technical skills across the associated unit operations, an understanding of, and stringent compliance to, GxP with an understanding of scientific concepts.

Your Role

Reporting to the Senior Scientist or Manager within the Pilot Scale Operations Department, you will be responsible for:

• Coordination, execution and real-time data collection/entry/documentation of routine tangential flow filtration, formulation, fill & finish operations. Primary data analysis and reporting of results to Senior Scientist/Manager
• Contribute to the successful completion (as measured by product yield, quality & consistency and the achievement of Project timelines) of manufacturing campaigns
• Proficient in manufacturing operations in alternative facilities on site and able to conduct operations in these facilities
• Help train new team members under Senior Scientist/Manager guidance
• Support role in change controls, process investigations, risk assessments and validation activities. Close out of assigned tasks associated with such activities
• Order and tracking of raw material and consumable stocks, if applicable
• On-call duties
• Identify opportunities for improvement and bring these to the team for assessment/implementation
• Ensure high safety standards are followed as governed by local, state and federal regulations, laws and policies and CSL’s policies and directives

Your experience

• Postgraduate degree (preferably PhD, MSc or equivalent degree) and / or experience in relevant discipline
• 5+ years relevant industry experience with BS, 3+ years relevant industry experience with MS, or relevant industry experience with PhD

• 3+ years laboratory experience with training in a relevant technical/scientific discipline
• Developed operational experience in tangential flow filtration, formulation, fill & finish operations within clean room facilities
• Experience executing manufacturing instructions in both paper or electronic formats. Understanding of scientific concepts and application thereof.
• Demonstrated understanding of GxP, regulatory requirements, validation principles and environmental, health and safety requirement in manufacturing areas
• Proficient in data analysis and reporting
• Familiarity with scale up, technology transfer and process validation activities

If you would like to join a purpose-driven, values-based organisation, apply now!

Please submit your application including your resume by 24 October 2023

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.