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 Microbiologist 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.
