Microbiologist Specialist

Viral Vector Manufacturing Facility Pty Ltd; Sydney; Sur place; AUD 70 000 - 100 000; Plein temps

Résumé du poste

Viral Vector Manufacturing Facility Pty Ltd – Westmead NSW is Australia’s first commercial viral vector CDMO, integrating with health and research precinct. We are seeking an experienced QC Microbiology professional to support microbiology quality control and GMP-compliant operations that enable advanced therapies.

Reporting to the QC/QA Manager, you will perform microbiological testing, environmental monitoring, investigations and continuous improvement, balancing hands-on lab work with

Qualifications

• Bachelor degree in chemistry, pharmacy, biology or equivalent.
• At least two years’ experience in QC microbiology in pharma/chemical.
• Working knowledge of cGMP and data integrity principles.
• Experience with microbiological testing and environmental monitoring.
• Strong analytical and problem-solving skills with attention to detail.

Responsabilités

• Perform and support microbiological testing of materials, media, samples and water.
• Support sterility, endotoxin, bioburden and microbial limits testing per regulatory requirements.
• Coordinate environmental monitoring across air, surfaces, water and personnel.
• Support analytical method qualification, validation and transfer.
• Analyze QC data, identify issues and implement improvements.
• Author and review investigations and support QMS record management.
• Contribute to audits and inspection readiness.
• Provide microbiology guidance and training across stakeholders.

Connaissances

QC Microbiology

Environmental monitoring

Data integrity

Regulatory compliance

Formation

Bachelor's degree in chemistry/pharmacy/biology

Description du poste

Viral Vector Manufacturing Facility Pty Ltd – Westmead NSW

VVMF is Australia’s first commercial manufacturing facility of its kind, uniquely integrated within the country’s largest health, education, research, and innovation precinct based at Westmead. As a viral vector Contract Development and Manufacturing Organisation (CDMO), we are setting new standards in the production of clinical and commercial-grade viral vectors for advanced therapies.

We are values-driven, committed to quality and innovation, and we’re looking for an experienced Quality Control (QC) Microbiology professional to support our microbiology quality control capability. This is a hands-on role where you’ll contribute to specialist testing, environmental monitoring and GMP-compliant operations that help deliver advanced therapies with the potential to change lives.

Our opportunity

Reporting to the Quality Control and Assurance Manager, you will support daily QC microbiology operations and contribute to the development, implementation and continual improvement of microbiological processes and procedures.

• Perform and support microbiological testing of materials, media, in-process samples, finished products, environmental samples, stability samples and water samples.
• Support sterility, endotoxin, bioburden and microbial limits testing in line with regulatory requirements.
• Coordinate and support the facility environmental monitoring program across air, surfaces, water and personnel.
• Support analytical method qualification, validation, verification and transfer activities.
• Analyse QC data and trends, identify potential issues and help implement improvements.
• Author and review deviation, Out of Specification and Out of Trend investigations, and support timely QMS record management.
• Contribute to inspection readiness and internal, supplier, customer and regulatory audits.
• Provide microbiology guidance and training, and collaborate across internal and external stakeholder groups.

About you

You are a practical, quality-focused microbiology professional who enjoys working in a collaborative environment and can balance hands-on laboratory activities with documentation, investigation and continuous improvement responsibilities.

• A bachelor’s degree in chemistry, pharmacy, biology or an equivalent discipline.
• At least two years’ experience in a similar role, including microbiology experience in a pharmaceutical or chemical environment.
• Working knowledge of cGMP, data integrity principles and Quality System regulations relevant to a QC laboratory.
• Experience with microbiological testing, environmental monitoring and investigation processes.
• Strong analytical, problem-solving and decision-making skills, with excellent attention to detail.
• Clear written and verbal communication skills and the ability to work effectively across functions.
• A positive, adaptable and solutions-focused approach, with personal alignment to VVMF’s values.
• Flexibility to support production activities outside usual business hours when required, including early starts, afternoons, evenings or weekends.
• Experience in sterile manufacturing, biotechnology or a CDMO environment will be highly regarded.

Applicants must be willing to undergo a National Police Check. Only shortlisted applicants will be contacted.