Agency for Science, Technology and Research – QueenstownSeeking a highly motivated scientist to join the ImmunoDiagnosticsteam, focusedon developing regulated diagnostic products and services, especially in protein-based assays.
The candidate will have a wide range of exposure of different technology platform, such asbut not limited to ELISA, lateral flow, flow cytometry, electrochemical sensor, and mass spectrometry.The successful candidate can be a tech lead in the development for wide range of clinical application andwill work closely with clinical and commercial stakeholders to deliver successful and impactful solutions.Key ResponsibilitiesResponsible for good records and standard operating procedures (SOPs) in accordance with confidential information requirement, quality system and regulatory guidelines.Mentor junior and refresh the latest tech development and product landscape.Provide prompt supports and communications for internal and external collaborators.Assay planning andexecution.Responsible for presentation for progress, finding, and solution to internal and external stakeholder.Responsible for technical development timeline and troubleshooting.Contribute to project scoping and preparing project proposals with in-depth understanding in clinical workflow, clinical unmet needs, technology value proposition, economic value capture, clinical deployment, and product commercialization pathway.Contribute to product landscape study on safety dossier and technical note approved by regulators.Contribute to clinical study design, clinical trial in regulated diagnostic product settings.Manage and perform lab operations activities, including general laboratory and equipment housekeeping and qualifications, and consumables purchasing.RequirementsEducation in Biochemistry, Cell Biology,Molecular Biology, Biotechnology, or a related field.At least 5 yearsof hands-on experience in protein-based assay development, preferably in industrial, diagnostics or clinical laboratory setting.Strong scientific foundation, demonstrated critical thinking abilities, and proven experience applying first-principles methodology.Strong track record in experimental design, troubleshooting, and optimisation of laboratory workflows.Laboratory skills in techniques in pre-analytical and analytical, including extensive knowledge and hand-on experience in protein-based techniques.Familiarity with regulatory and quality standards for diagnostic assay development e.g. ISO
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Scientist • Queenstown, New Zealand