Senior Scientist, General Product Characterisation
Senior Scientist, General Product Characterisation
Apply locations: APAC, AU, Victoria, Parkville, CSL Limited Melbourne Time type: Full time Posted on: Posted 5 Days Ago Time left to apply: End Date: January 24, 2025 (4 days left to apply) Job requisition id: R-248374 This is a Fixed term contract between 1 March 2025 to 28 February 2026. The Role: Leading the strategic thinking, planning, execution and evaluation of characterisation studies, aligning with CSL internal policy and regulatory guidance (e.g., ICH Q5E, Q6B, FDA/EMA guidance documents). Ensure ongoing compliance with R&D Quality System and regulatory requirements, including participation in both internal and external audits as required. Ensures the highest level of Data Integrity by complying with relevant scientific and/or data standards (e.g., LIMS data entry & retrieval, ELN workflows, structured data principles). Planning, performing, reporting and troubleshooting both routine and non-routine characterisation assays. Utilises expert technical skills to generate data with accuracy, consistency and timeliness in accordance with current SOPs and provide expert review to ensure scientific and data standards are sufficient to support process development, batch release and stability, and product characterisation objectives. Assesses new instruments, technology and techniques for potential implementation within Bioanalytical Sciences and makes recommendations to Departmental management, with appropriate guidance. Takes an active role in maintaining effective lab operations, including lab housekeeping duties (e.g., instrument maintenance, reagent preparation, stock ordering, liaising with instrument technicians, lab cleaning). Completes own training in a timely manner to stay above agreed KPI level, supports team leader in providing effective training of new staff. Plays a leading role in technical, operational and organizational discussions and regularly presents work at team meetings, Departmental meetings (e.g., Progress meetings) and cross-functional teams (e.g., AETs, PDETs, etc.). Ensure high safety standards for both self and others as governed by local, state and federal regulations, laws and policies as well as CSL’s policies and directives. This position may involve direct management of Scientists and other junior staff (e.g., Associate Scientists or supervision of student placements). Your skills and experience: Postgraduate degree (preferably PhD, MSc or equivalent degree) and/or extensive experience in relevant discipline. Minimum of 3 years relevant industry experience and/or equivalent experience in a relevant academic environment. In-depth expertise in protein biochemistry and analytical characterisation techniques. Knowledge of wider drug product development and regulatory requirements in pharmaceutical drug development. Experience outsourcing analytical methods/work packages or performing technology transfers (desirable). Highly proficient in generating and analysing high quality data, troubleshooting issues, reporting results and presenting them to a range of both internal and external customers. Experience leading projects in cross-functional teams. Ability to effectively schedule and prioritise own work schedule in consultation with team leader, and support team leader in planning and prioritisation of team work schedule, with a demonstrated ability to close out assigned tasks in a timely manner and assist with tracking of team objectives. Highly motivated and have strong interpersonal skills. Strong written (technical/scientific), oral and presentation skills. Strong communication and organisational skills. Able to react positively to changes in the work environment and take on feedback receptively. How to Apply: Please submit your application including your
CV and Cover Letter addressing the selection criteria
listed under Your Skills & Experience section above. Applications close on
24 January 2025. 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!
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.
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Apply locations: APAC, AU, Victoria, Parkville, CSL Limited Melbourne Time type: Full time Posted on: Posted 5 Days Ago Time left to apply: End Date: January 24, 2025 (4 days left to apply) Job requisition id: R-248374 This is a Fixed term contract between 1 March 2025 to 28 February 2026. The Role: Leading the strategic thinking, planning, execution and evaluation of characterisation studies, aligning with CSL internal policy and regulatory guidance (e.g., ICH Q5E, Q6B, FDA/EMA guidance documents). Ensure ongoing compliance with R&D Quality System and regulatory requirements, including participation in both internal and external audits as required. Ensures the highest level of Data Integrity by complying with relevant scientific and/or data standards (e.g., LIMS data entry & retrieval, ELN workflows, structured data principles). Planning, performing, reporting and troubleshooting both routine and non-routine characterisation assays. Utilises expert technical skills to generate data with accuracy, consistency and timeliness in accordance with current SOPs and provide expert review to ensure scientific and data standards are sufficient to support process development, batch release and stability, and product characterisation objectives. Assesses new instruments, technology and techniques for potential implementation within Bioanalytical Sciences and makes recommendations to Departmental management, with appropriate guidance. Takes an active role in maintaining effective lab operations, including lab housekeeping duties (e.g., instrument maintenance, reagent preparation, stock ordering, liaising with instrument technicians, lab cleaning). Completes own training in a timely manner to stay above agreed KPI level, supports team leader in providing effective training of new staff. Plays a leading role in technical, operational and organizational discussions and regularly presents work at team meetings, Departmental meetings (e.g., Progress meetings) and cross-functional teams (e.g., AETs, PDETs, etc.). Ensure high safety standards for both self and others as governed by local, state and federal regulations, laws and policies as well as CSL’s policies and directives. This position may involve direct management of Scientists and other junior staff (e.g., Associate Scientists or supervision of student placements). Your skills and experience: Postgraduate degree (preferably PhD, MSc or equivalent degree) and/or extensive experience in relevant discipline. Minimum of 3 years relevant industry experience and/or equivalent experience in a relevant academic environment. In-depth expertise in protein biochemistry and analytical characterisation techniques. Knowledge of wider drug product development and regulatory requirements in pharmaceutical drug development. Experience outsourcing analytical methods/work packages or performing technology transfers (desirable). Highly proficient in generating and analysing high quality data, troubleshooting issues, reporting results and presenting them to a range of both internal and external customers. Experience leading projects in cross-functional teams. Ability to effectively schedule and prioritise own work schedule in consultation with team leader, and support team leader in planning and prioritisation of team work schedule, with a demonstrated ability to close out assigned tasks in a timely manner and assist with tracking of team objectives. Highly motivated and have strong interpersonal skills. Strong written (technical/scientific), oral and presentation skills. Strong communication and organisational skills. Able to react positively to changes in the work environment and take on feedback receptively. How to Apply: Please submit your application including your
CV and Cover Letter addressing the selection criteria
listed under Your Skills & Experience section above. Applications close on
24 January 2025. 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!
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.
#J-18808-Ljbffr
