Microbiological Analyst QC

Job description

Melbourne, Australia | full time | Job ID: 11302 About the Role: As a QC Microbiology Analyst, you will play a pivotal role in shaping the microbiology operations for our new clinical manufacturing facility in Australia. This is your opportunity to contribute to BioNTech’s mission by building high-quality microbiological methods and workflows that adhere to TGA, PIC/S, and global GMP standards. You will be instrumental in establishing infrastructure, qualifying equipment, and implementing systems while collaborating closely with cross-functional teams. Your work will directly support our commitment to delivering safe and effective clinical trial products, ensuring compliance with regulatory standards. Your Contribution: - Support 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. - Perform QC microbiological testing for cleanrooms, utilities, raw materials, product release, and stability studies. - Lead method transfer, development, validation activities following ICH Q2(R2), Q14, and compendial requirements. - Monitor environmental programs through data r...