Research Scientist

Department of Health, Disability and Ageing; Australia; Presencial; AUD 130 000 - 170 000; Tempo integral

Resumo da oferta

The Therapeutic Goods Administration (TGA) Laboratories Branch seeks a motivated scientist to lead quality control testing of vaccines and biological medicines, applying LC-MS, HPLC/UPLC, PCR and ELISA.

You will drive method development, validation, batch release assessments, and surveillance programs, contributing to regulatory decisions and maintaining ISO/IEC 17025 compliance while mentoring staff and engaging stakeholders.

Qualificações

• Demonstrated laboratory experience with vaccines or biological products.
• Strong analytical and problem-solving skills in regulated environments.
• Excellent communication and stakeholder engagement capabilities.

Responsabilidades

• Lead the development, validation and implementation of analytical methods for the testing of vaccines and biological medicines using HPLC, Ultra-Performance Liquid Chromatography (UPLC) and LC-MS technologies.
• Manage the assessment of vaccine and biological medicine batch release data and oversee the implementation of manufacturer test methods to ensure compliance with regulatory requirements, quality standards and relevant legislative frameworks.
• Coordinate and deliver pre-market and post-market monitoring, surveillance and testing programs for vaccines and biological medicines, providing scientific expertise and risk-based recommendations to support regulatory decision-making.
• Contribute to the development, review and implementation of scientific guidelines, technical policies and procedures, including the evaluation of international standards, emerging technologies and regulatory developments.
• Maintain and continuously improve the Quality Management System, ensuring compliance with ISO/IEC 17025 requirements and supporting activities necessary to maintain NATA accreditation.
• Lead, coach and mentor scientific staff, fostering technical capability, professional development, knowledge sharing and a culture of continuous improvement and high performance.
• Build and maintain productive relationships with internal and external stakeholders, providing expert technical advice and representing the organisation at national and international forums, committees and working groups.
• Manage complex projects and competing priorities in a high-pressure environment, providing leadership support and contributing to the achievement of team, branch and organisational objectives.

Conhecimentos

Analytical thinking

Problem-solving

Leadership

Communication

Ferramentas

LC-MS

HPLC/UPLC

PCR

ELISA

Descrição da oferta de emprego

The Therapeutic Goods Administration (TGA) is seeking a motivated and experienced scientist to join the Laboratories Branch. The successful applicant will undertake quality control testing of vaccines and biological medicines using a range of physicochemical, immunological, and molecular techniques, including Liquid chromatography–mass spectrometry (LC-MS) , High-Performance Liquid Chromatography (HPLC) , Polymerase Chain Reaction (PCR), Enzyme-Linked Immunosorbent Assay (ELISA). The role also contributes to vaccine batch release activities, scientific assessments, research projects, quality management systems, and the work program supporting the laboratory's World Health Organization (WHO) Collaborating Centre and Essential Regulatory Laboratory functions. Applicants should have demonstrated laboratory experience in vaccine or biological product testing, strong analytical and problem-solving skills, and the ability to work independently in a regulated environment. Experience with vaccine potency assays, immunochemistry, protein and polysaccharide analysis, mass spectrometry, good manufacturing practice (GMP) or ISO/IEC 17025 quality systems will be highly regarded. Strong communication, stakeholder engagement and leadership capabilities are essential.

Key responsibilities

• Lead the development, validation and implementation of analytical methods for the testing of vaccines and biological medicines using HPLC, Ultra-Performance Liquid Chromatography (UPLC) and LC-MS technologies.
• Manage the assessment of vaccine and biological medicine batch release data and oversee the implementation of manufacturer test methods to ensure compliance with regulatory requirements, quality standards and relevant legislative frameworks.
• Coordinate and deliver pre-market and post-market monitoring, surveillance and testing programs for vaccines and biological medicines, providing scientific expertise and risk-based recommendations to support regulatory decision-making.
• Contribute to the development, review and implementation of scientific guidelines, technical policies and procedures, including the evaluation of international standards, emerging technologies and regulatory developments.
• Maintain and continuously improve the Quality Management System, ensuring compliance with ISO/IEC 17025 requirements and supporting activities necessary to maintain NATA (National Association of Testing Authorities) accreditation.
• Lead, coach and mentor scientific staff, fostering technical capability, professional development, knowledge sharing and a culture of continuous improvement and high performance.
• Build and maintain productive relationships with internal and external stakeholders, providing expert technical advice and representing the organisation at national and international forums, committees and working groups.
• Manage complex projects and competing priorities in a high-pressure environment, providing leadership support and contributing to the achievement of team, branch and organisational objectives.

Key capabilities

• Strong strategic, analytical, and problem-solving skills and ability to apply these when troubleshooting of analytical methods and instruments.
• In-depth knowledge of physicochemical analytical techniques used in the laboratory testing of therapeutic goods and of laboratory quality management systems.
• Strong oral and written skills, including experience in communicating technical and analytical problem-solving & concepts to both technical and non-technical stakeholders.
• Demonstrated planning and organisational skills, including ability to meet deadlines with competing priorities and delivering work to a high standard with good attention to detail.
• The ability to work independently within their level of responsibility, managing competing priorities and delivering high-quality outcomes under the direction of senior staff.
• Motivation to contribute to public health outcomes and to develop specialist expertise in medical devices and therapeutic goods.

Desirable experience and qualifications

• Laboratory experience (greater than 3yrs) in one or more of the following analytical areas - protein and polysaccharide analysis using U/HPLC and mass spectrometry, vaccine potency assays, and immunochemistry and molecular biology.
• Experience working in a regulated laboratory environment e.g. GMP compliance or ISO/IEC 17025 accredited laboratory.
• In-depth knowledge of techniques used in the laboratory testing of therapeutic goods and of laboratory quality management systems.