Senior Scientist

1 month ago

Parkville, Australia CSL Full time

The Opportunity

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.

We are recruiting for a Senior Scientist, Assay Development Group (ADG) to join our Biopharmaceutical Product Development (BPD) team.

Reporting to the Senior Manager – Analytical Development , you will develop assays to support product development activities, release tests, and/or patient sample analysis where required and report results.

You will lead and contribute to ADG activities, including oversight of team objectives in support of departmental / divisional deliverables. You will develop analytical methods and provide scientific expertise for the development of analytical workflows in support of Biopharmaceutical Product Development activities.

You will develop, maintain and operate facilities, systems and equipment used by the ADG to ensure compliance, and develop and document unit operations to comply with relevant quality and regulatory standards.

The Role

Develop and qualify varied analytical HPLC methods (including but not limited to size-exclusion, ion-exchange, reverse-phase, etc) to support Release, Characterisation and Routine testing of biotherapeutics. Ensure scientific data & work packages undergo sufficient review to support appropriate conclusions and decision-making. Provide scientific expertise and guidance in relevant area of research and product development. Provide troubleshooting & technical support as required, to ensure continuity of operations. Represent ADG in cross-functional teams, and support collaborative work with PPD & Seqirus colleagues. Provide strong representation for the ADG team and support staff professional development e.g., training, conference attendance. Ensure robust adherence to external guidelines (e.g., TGA, FDA etc) as required in order to maintain high levels of compliance for GXP processes. Develop other analytical methods as required in consultation with relevant stakeholders.

Your skills and experience

Postgraduate degree (preferably PhD, MSc or equivalent degree) and / or experience in relevant discipline:6+ years relevant industry experience with MS; (or)2+ years relevant industry experience with PhD Demonstrated experience in HPLC Method Development. Experience in project work and excellent communication and analytical skills. Ability to lead and contribute in a cross-functional, multi-disciplinary team environment. Experience in biopharmaceutical development in relevant scientific disciplines including (but not limited to) Analytical, Molecular Biology, Virology, Cell Culture, Purification. Skilled in Quality by Design principles including statistical experimental design.

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 12 June 2024 .

"#LI-Hybrid"

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.

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