Lead Vaccine QC & Analytical Scientist

Department of Health, Disability and Ageing; Australia; Sur place; AUD 130 000 - 170 000; Plein temps

Résumé du poste

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.

Qualifications

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

Responsabilités

• 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.

Connaissances

Analytical thinking

Problem-solving

Leadership

Communication

Outils

LC-MS

HPLC/UPLC

PCR

ELISA

Description du poste

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.