19 Aug
|
GPN Vaccines
|
Adelaide
19 Aug
GPN Vaccines
Adelaide
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 workplace.
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 ****
📌 Scientist (Adelaide)
🏢 GPN Vaccines
📍 Adelaide