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
Job Summary
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.
Matching Summary
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.
Skills & Requirements
Must-have
QC Chemistry laboratory establishment
TGA and global GMP standards
method transfer, development, validation
data integrity for computerized systems
deviations, OOS investigations, CAPA
Nice-to-have
cross-functional team collaboration
adapting to evolving environments
clinical product manufacturing support
Key Requirements
Bachelor’s degree or higher in Chemistry, Pharmaceutical Sciences, Biochemistry, or related field
At least 3 years of QC experience in GMP aseptic manufacturing or start-up/greenfield projects
Expertise in method development, transfer, qualification, and validation processes
Knowledge of Australian GMP guidelines, TGA requirements, and PIC/S standards
Familiarity with data integrity (ALCOA+), deviations management, OOS/OOT investigations, CAPA processes, and change control systems