Principal Scientist
2 weeks ago
AusBiotech is seeking a highly motivated Principal Scientist - Diagnostics to join our collaborative and commercially focused R&D team. As a key member of our diagnostics program, you will lead the development of clinically and commercially relevant products that have a meaningful impact for patients, clinicians, and healthcare.
Key Responsibilities:- Plan, manage, execute, and report on biomarker discovery, analytical and clinical validation studies for in vitro diagnostics to meet agreed technical, development, and registration milestones on time and within budget.
- Ensure the maintenance of accurate laboratory records to secure intellectual property and document design control in accordance with regulatory guidelines.
- Manage external projects with diagnostics collaborators, partners, contract research/manufacturing organisations, and consultants to meet agreed timelines, budgets, and outcomes.
- Perform and report data analyses of biomarker and assay performance using relevant statistical packages.
- Identify and evaluate new diagnostic technologies and product opportunities.
- Supervise, train, and manage the diagnostics team.
- Liaise with regulatory consultants and agencies to ensure alignment with global LDT and IVD requirements.
- PhD in Molecular and Cell Biology, Biochemistry, Genetics, Endocrinology, Immunology, or another relevant field.
- Minimum 5+ years of relevant laboratory research experience, including 3+ years as a principal scientist working in a pharmaceutical or diagnostics industry setting with responsibility for diagnostics development.
- Proven track record in clinical diagnostics development, including biomarker discovery, analytical validation, clinical validation of in vitro diagnostics for Oncology, or other relevant area.
- Significant research management experience with responsibility for design and execution of research plans, statistical data analysis and interpretation, progress reporting, and preparation of technical reports, publications, and presentations on research findings.
- Knowledge of immuno- and molecular diagnostic development, standard diagnostic instrument platforms, and IVD medical device regulatory requirements.
- Strong planning, critical thinking, and analytical skills with ability to solve specific research questions and technical issues.
- Broad knowledge of omics techniques across proteomics, glycomics, and genomics technologies and application to biomarker discovery and diagnostics translation to clinically and commercially relevant products.
- Demonstrated knowledge of quality, regulatory, and safety standards for laboratories and GMP regulations, including ISO17025/ISO13485/21 CFR 820 and IVDR 2017/246.
- Strong interpersonal, communication, and presentation skills with ability to communicate both orally and in writing.
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Principal Research Scientist
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Melbourne, Victoria, Australia Ausbiotech Full timeExciting Opportunity for a Principal ScientistWe are seeking a highly motivated and experienced Principal Scientist to join our collaborative and commercially focused R&D team at Ausbiotech. As a key member of our diagnostics program, you will lead the development of clinically and commercially relevant products that have a meaningful impact for patients,...
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Melbourne, Victoria, Australia AusBiotech Full timeJob Title: Principal Scientist - DiagnosticsWe are seeking a highly motivated and experienced Principal Scientist to join our R&D team at AusBiotech. As a key member of our diagnostics program, you will lead the development of clinically and commercially relevant products using our cutting-edge technologies.Key Responsibilities:Plan, execute, and report on...
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4 weeks ago
Melbourne, Victoria, Australia Ausbiotech Full timeJob Title: Principal Scientist - DiagnosticsWe are seeking a highly motivated and experienced Principal Scientist to join our R&D team at Ausbiotech. As a key member of our diagnostics program, you will be responsible for leading the development of clinically and commercially relevant products.Key Responsibilities:Plan, execute, and report on diagnostics...
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