Chemistry Analyst QC

Job description

Melbourne, Australia | full time | Job ID: 11301 About the Role: As a QC Chemistry Analyst, you will be at the forefront of establishing the QC Chemistry laboratory for our new clinical manufacturing facility in Australia. Your work will directly contribute to BioNTech’s mission by ensuring high-quality analytical methods and workflows that align with TGA and global GMP standards.This is an exciting opportunity to shape the future of our QC operations by developing infrastructure, qualifying equipment, implementing systems, and supporting clinical product manufacturing. You will work closely with cross-functional teams to ensure compliance and operational excellence. Your Contribution: - Support the qualification and operational readiness of the QC Chemistry Laboratory. - Develop and implement SOPs, workflows, and quality systems aligned with TGA and PIC/S guidelines. - Perform QC testing for raw materials, product release, and stability studies. - Lead method transfer, development, validation, and verification activities in accordance with ICH Q2(R2), Q14, and compendial requirements. - Ensure data integrity for computerized systems (e.g., LIMS, Empower) in compliance with TGA exp...