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 review, trend analysis, and investigation of excursions.
• Ensure GMP compliance, data integrity (ALCOA+), and adherence to compendial requirements in all operations.

A Good Match:

• Bachelor’s degree or higher in Microbiology, Biotechnology, or related field.
• At least 3 years of QC experience in GMP aseptic manufacturing or start-up/greenfield projects.
• Proficiency in method development, transfer, qualification, and validation processes.
• Knowledge of Australian GMP guidelines, TGA requirements, and PIC/S standards.
• Experience handling deviations, OOS investigations, CAPAs, and change control systems.
• Strong verbal and written communication skills with the ability to adapt to evolving 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 ‘Hire Right’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.