POSITION SUMMARY

GPN Vaccines is seeking two motivated Scientists to support immunological testing.

The Scientist is responsible for designing, executing, and documenting immunoassay-based experiments within a GCLP laboratory. The role supports clinical trial sample testing, method development, assay validation, and generation of high-quality data that meets regulatory standards.

KEY RESPONSIBILITIES

- Perform immunoassays as required.
- Handle clinical samples in alignment with GCLP and biosafety requirements.
- Develop and optimise immunoassays.
- Review and interpret data with attention to validity, trends and QC acceptance criteria.
- Ensure all results and reports meet GCLP standards, including audit-ready completeness, traceability and reproducibility.
- Perform validation and verification of analytical methods and instruments as needed.
- Prepare technical summaries, validation reports, and study documentation for internal and external stakeholders.
- Participate in internal and external audits by providing records and explaining procedures when needed.
- Report deviations, non-conformances,



or equipment failures to the Laboratory Manager and Quality Assurance.
- Support quality improvement initiatives and contribute to ongoing GCLP compliance.
- Assist with instrument maintenance, calibration and performance monitoring.

Essential

- PhD in immunology, molecular biology, biochemistry, or related field
- Solid understanding of GCLP principles, documentation standards, and regulatory expectations.
- Proven capability in handling and processing clinical trial samples.

Desirable

- Experience validating immunoassays for clinical trial use.
- Hands-on laboratory experience with immunoassays in an industry, CRO, or clinical testing setting.

- Exposure to LIMS, ELN, and GxP-compliant data systems.
- Familiarity with ICH guidelines, FDA/TGA/EMA expectations, and method lifecycle management.
- Flow cytometry panel design, cell culture, and functional assay experience.

Applications close 16th January 2026

📌 Scientist (Adelaide)
🏢 Recognized
📍 Adelaide