Job Description

We have an opportunity available for a Senior Scientist, Assay Development Group to join our Biopharmaceutical Product Development team. In this role, you will lead and contribute to Assay Development Group (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.

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.

Key Responsibilities Include:

• Develop and qualify analytical methods that investigate biomolecular interactions (including ELISA, enzyme-kinetics, 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

To be successful, you will require:

• Postgraduate degree (preferably PhD, MSc or equivalent degree) and / or experience in relevant discipline

• 8+ years relevant industry experience with BS,
• 6+ years relevant industry experience with MS, or
• 2+ years relevant industry experience with PhD

• Minimum of 3 years relevant industry experience and / or equivalent experience in a relevant academic environment
• 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

Applications must include a CV and Cover Letter addressing the selection criteria.

Applications Close 16th June 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.