Senior Process Scientist
2 months ago
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 contract until 31st December 2025 .
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 analyze 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 Background in Pharma industry preferred Knowledge of cGMP regulations Knowledge of Quality Management Systems Experience with engineering, equipment, and automation principles and the ability to apply knowledge. Strong experience and knowledge of vaccine and/or antivenom manufacturing processes. Experience with cell culture-based or plasma derived manufacturing products preferred.How to Apply
Please submit your resume and cover letter (in one document), addressing the selection criteria. Applications close on Wednesday, 29th May 2024.
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.
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