Chemistry Analyst QC
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 expectations.
- Contribute to deviations, OOS investigations, stability trends analysis, and CAPA implementations.
A Good Match:
- Bachelor’s degree or higher in Chemistry, Pharmaceutical Sciences, Biochemistry, or a 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.
- Strong ability to adapt to evolving environments with rapidly changing priorities.
What we do with the BioNTainers:
We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA-manufacturing facilities based on a container solution called “BioNTainers”. Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional end-to-end mRNA manufacturing solutions.
Benefits for you:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Click here to find out more about what we do, the careers we offer ans also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.