APS Level 6 - Vaccine Scientist, Biotherapeutics Section (several positions)The Biotherapeutics Section within the Therapeutic Goods Administration, is seeking an enthusiastic and engaged Vaccine Scientist to join the team.
You will be contributing to our regulatory testing of Vaccines and Biotherapeutic products in Australia, as well as building new test capabilities within the laboratory.
Position Duties:
• Undertake quality control testing of vaccines using a variety of immunological based techniques such as cell culture, in vitro gene expression assays, PCR, ELISA, immunodiffusion, protein and polysaccharide analysis.
• Contribute to the work program in support of the sections accreditation as a WHO Collaborating Centre for Quality Assurance of Vaccines and other Biologicals and an Essential Regulatory laboratory (ERL).
• Undertake research, analysis, integration and evaluation of technical information and/or scientific data.
• Undertake evaluation of manufacturer's batch records as part of the batch release program.
• Prepare timely, high-quality reports that summarise and provide an independent scientific assessment of the data submitted. Make recommendations based on scientific assessment, outlining risks and effectiveness of mitigations.
• Prepare procedural or technical manuals and guidelines for the Laboratories Branch quality management system (QMS). Contribute to the maintenance and development of the QMS.
• Work with independence, subject to limited direction against priorities, practices, and methodologies as set out in the QMS to deliver quality outcomes.
• Propose innovation initiatives and contribute to business improvement.
• Contribute to managing change and uncertainty in the workplace.
• Ensure quality outputs for a team including the development of specialist, professional and/or technical expertise. Conduct regular quality assurance of work area processes and manage identified risks.
• Develop and support complex relationships with internal and external stakeholders through the provision of accurate and timely technical and regulatory advice on vaccines.
Mandatory Qualification:
To be eligible for this position applicants must hold a degree in an area of relevance to vaccines and biological medicines such as immunology, virology, biotechnology, protein chemistry.
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