Team Lead QC Microbiology AS&T

The Team Lead QC Microbiology/AS&T is responsible for establishing and leading QC Microbiology and Analytical, Science & Technology functions for a new clinical manufacturing facility in Australia. This role is pivotal in building the QC microbiology operations from the ground up - developing infrastructure, implementing systems, recruiting, qualifying equipment, training staff, and setting up high-quality microbiological methods and workflows aligned with TGA, PIC/S, and global GMP standards.

Requirements

• Lead the qualification and operational readiness of the QC Microbiology Laboratory
• Develop and implement SOPs, workflows, and quality systems aligned with TGA and PIC/S guidelines
• Serve as an SME in method transfer, development, validation activities, and provide technical leadership during OOT/OOS investigations and regulatory inspections
• Perform and/or review microbiological testing for cleanrooms, clean utilities, raw materials, product release, and stability studies
• Oversee method development, transfer, verification, validation activities, and support AS&T activities such as troubleshooting, continuous improvement, and implementation of new microbiological technologies
• Recruit, train, and mentor QC microbiology/AS&T staff
• Prepare for internal audits and regulatory inspections
• Partner with QA, MS&T, SCM, and manufacturing to support technology transfers, clinical batch release, facility qualification, cleanroom classification, and utility/system activities

Benefits

• Competitive remuneration packages
• Wellbeing support