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About the Company Our client is a rapidly growing contract development and manufacturing organization (CDMO) specialising in the production of mRNA and lipid nanoparticle (LNP) packaged vaccines. Our commitment lies in delivering high-quality nucleic acid products that meet stringent regulatory standards and exceed customer expectations. About the Role We are seeking an experienced and proactive Senior Microbiologis t to establish and lead a new cGMP-compliant and NATA-accredited microbiology laboratory. This pivotal role involves developing testing workflows, ensuring regulatory compliance, and contributing to the successful manufacturing of mRNA drug substances and products for Phase I & II clinical trials. Key Responsibilities: Develop and implement testing workflows for facility environmental monitoring (EM), in-process control (IPC), and release testing of mRNA drug substances (DS) and drug products (DP). Undertake method transfer, qualification/validation activities, and support cleaning validation, environmental monitoring performance qualification (EMPQ), and ongoing facility verification. Generate scientifically sound outputs for client analytical testing in compliance with TGA regulatory requirements. Author microbiology-specific testing documentation and liaise with senior production and QC staff regarding batch sampling plans, DS or DP specification documents, and qualification and validation protocols and reports. Liaise with clients and regulators on all aspects of microbiology (process and facility) and confidently manage client inquiries and expectations. Ideal Candidate Profile Bachelor's degree or higher in Microbiology; postgraduate qualifications are beneficial but not essential. Strong background in analytical theory and technical competency with microbiological analysis. At least 5 years of experience in the pharmaceutical industry, aligned with microbiological and QC disciplines. Expertise in laboratory testing techniques, assay development, and/or analytical method validation suitable for the pharmaceutical or biologics industry. Comprehensive knowledge of GXP regulations. Demonstrated ability to work in a highly dynamic and frequently changing environment. Effective communication skills across multiple modalities (electronic, written, verbal). Proven ability to manage multiple projects simultaneously. Strong collaborative skills. Benefits: Opportunity to lead and shape a new microbiology laboratory within a cutting-edge CDMO. Collaborative and inclusive work environment. Professional development and career advancement opportunities. Competitive remuneration package How to Apply Interested candidates are invited to submit a cover letter detailing their relevant experience and interest in the role, along with a current CV (MS Word format). CLICK APPLY NOW if you meet the above criteria or for a confidential discussion, please contact Ruby at KE Select on 0481 200 171. KE Select is one of Australia's leading Life Science & Medical Technology recruitment firms. KE Select have established reach throughout ANZ, Asia and the UK and a market presence exceeding ten years. KE Select is quickly becoming the recruiter of choice for many organisations within the Pathology, Life Science, Pharmaceutical, Medical Device and Clinical space.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Research, Analyst, and Information Technology
* Industries
Human Resources Services
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