COMPLETE Senior Process Scientist - APAC, AU, Parkville, Seqirus

The Opportunity

CSL Seqirus is looking for a Senior Process Scientist to join our dynamic team in our Manufacturing, Science and Technology (MS&T) function in Parkville (Australia). This role is a full-time, fixed term position until 31 March 2026.

Reporting to the MS&T Manager Process Sciences, you will provide technical expertise related to the process, equipment, and business systems that drive strategic improvements alongside the support of drug substance, drug product (Formulation) and/or Fill/Finish.

The Role

• Lead the development of the manufacturing process documentation including process descriptions, risk assessments, product impact assessments, and technical studies/protocols
• Provide technical expertise for multiple assigned unit operations and processes in the Influenza, AVAT and Q Fever manufacturing areas. Responsible for the reliability, robustness and analysis of assigned products and/or processes
• Assist in the management and maintenance of process monitoring using quality systems such as MODA, GLIMS, SAP, SAC
• Leads the execution of process validations, monitoring batch performance, and short-term improvement projects, liaising with all the relevant parties to ensure accurate execution
• Drive continuous improvement initiatives to proactively prevent process failures. Leverages process and compliance expertise to facilitate cross functional decision making and strategy alignment.
• Use scientific, statistical and process knowledge to analyse data to provide process understanding, and to identify root causes of product and process failures
• Assist with complex product and process investigations including but not limited to product technical complaints, deviations for out of expectation, out of specification, etc
• Contribute to Continued Process Verification and Product Quality Review by providing technical expertise on the products and processes

Your Skills and Experience

• Bachelor’s degree or higher in relevant technical / scientific field of study
• 5+ years of experience in a Pharmaceutical or Manufacturing environment
• Technical understanding of pharmaceutical manufacturing processes
• Background in Pharma industry preferred
• Knowledge of cGMP regulations
• Knowledge of Quality Management Systems
• Solid understanding of engineering, equipment, and automation principles and the ability to apply knowledge. 
• Strong experience and knowledge of vaccine and/or antivenom manufacturing processes. Experience with egg-based or plasma derived manufacturing products preferred.
• High level of attention to detail in order to solve a range of routine and non-routine problems.
• Strong customer focus and ability to work collaboratively with internal customers
• Demonstrated ability to meet targets and objectives
• Strong data analysis and problem-solving skills

Apply now to join a purpose-driven, values-based company committed to protecting public health!

Applications close 19 November 2023

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.

About 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.

We want CSL to reflect the world around us

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

Do work that matters at CSL!