• Exciting opportunity for an experienced, commercially orientated and ambitious Principal Scientist
• ASX-listed biotechnology company with a broad cancer diagnostics pipeline
• Salary negotiable, depending on experience
• Full-time position in Melbourne

INOVIQ Ltd (ASX:IIQ) is a biotechnology company developing next-generation diagnostics and therapeutics for cancer. Our diagnostics portfolio utilises proprietary exosome and glycomic technologies to develop blood tests for earlier detection, treatment selection and monitoring of cancer to improve patient outcomes.

Position Overview

We are seeking a highly motivated Principal Scientist to join our collaborative and commercially focused R&D team. The Principal Scientist - Diagnostics will lead INOVIQ’s diagnostics program to translate our cutting-edge technologies into clinically and commercially relevant products.  The successful candidate will play a pivotal role in advancing our novel diagnostic tests from biomarker translation through validation to registration. You will have a proven track record in scientific leadership with expertise in development and validation of in vitro diagnostics for early detection, treatment selection and/or monitoring of disease to improve patient outcomes.  If you have a passion for translating scientific innovations into impactful products, this opportunity is for you. Key responsibilities include planning, executing, and reporting on INOVIQ diagnostic programs in alignment with global quality and regulatory requirements to achieve R&D objectives.

Responsibilities

• Provide leadership of INOVIQ diagnostics programs to develop clinically and commercially viable products that have a meaningful impact for patients, clinicians, and healthcare.
• 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.

Essential Criteria

• 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.

How to Apply: Interested candidates can apply by submitting your resume and cover letter outlining your relevant experience and qualifications to [email protected] by 1st May 2024. For further information, please contact Dr Ramin Khanabdali on +61 3 9548 7586.

Please Note: Only shortlisted candidates will be contacted.

INOVIQ Ltd is an equal opportunity employer committed to diversity and inclusion.

• Join a pioneering ASX-listed biotechnology company revolutionizing cancer diagnostics and therapeutics
• Competitive salary package, commensurate with experience
• Full-time permanent position based in Melbourne, Australia
• Applications close: 15 August 2025

INOVIQ Ltd (ASX:IIQ) is a dynamic biotechnology company at the forefront of developing next-generation diagnostics and therapeutics for cancer. Our innovative portfolio harnesses proprietary exosome-based technologies to create advanced blood-based tests for early cancer detection, treatment selection and disease monitoring, ultimately improving patient outcomes. Additionally, our cutting-edge extracellular vesicle (EV) therapeutic program is pioneering novel treatments for cancer, positioning INOVIQ as a leader in exosome therapeutics.

We are a collaborative, innovative, and commercially driven organization, committed to excellence in research, development and product delivery. Join our passionate team and contribute to transformative advancements in healthcare.

Position Overview

We are seeking an experienced, proactive and detail-oriented Quality & Regulatory Manager (QRM) to join our Melbourne-based R&D team. Reporting to the Chief Scientific Officer (CSO), you will support our innovative research and product development pipeline, clinical development and regulatory activities in Australia and internationally and lead the continuous improvement of INOVIQ’s Quality Management System (QMS).  This critical role enables the successful execution of product development activities across research, preclinical and clinical studies for our diagnostic and therapeutic pipeline and ensures that our laboratory and manufacturing operations comply with global regulatory standards.

As a key member of our multidisciplinary team, you will drive quality and regulatory affairs, quality standards, regulatory compliance and operational excellence across the business to ensure INOVIQ’s products meet the highest standards for quality, safety and efficacy.

Key Responsibilities

• Quality and Regulatory Strategy: working together with INOVIQ’s senior management, R&D team and external consultants, develop and execute quality and regulatory strategies for products across INOVIQ’s diagnostic, therapeutic and research tools portfolio.
• Regulatory Submissions: Support the preparation and submission of regulatory dossiers, including:
  • Investigational Device Exemption (IDE), Pre-Market Approval (PMA) and equivalent submissions for In Vitro Diagnostic (IVD) products to various regulatory authorities.
  • Investigational New Drug (IND), New Drug Application (NDA) and equivalent submissions for therapeutic products, including EV-based therapies to various regulatory authorities.
• Study Support: Provide regulatory and quality guidance and oversight for LDT/IVD studies and IND-enabling studies, ensuring robust program management, study design, execution, and documentation at all stages of product development to ensure successful commercialisation.
• Quality Management System (QMS): Design, implement, and maintain a robust QMS to support R&D and commercial activities, ensuring alignment with INOVIQ’s Quality Policy and product development goals.
• Accreditation and Certification: Lead efforts to secure and maintain ISO17025 accreditation for laboratory competence and ISO13485 certification for medical device quality management, ensuring compliance with international standards.
• Regulatory Compliance: Oversee adherence to current Good Manufacturing Practices (cGMP) for manufacturing processes and ensure compliance with regulatory requirements for product development and commercialization.
• Laboratory Excellence: Ensure laboratory processes deliver accurate, reliable, and traceable results, meeting project timelines and budgetary requirements.
• Risk Management: Implement risk-based approaches to quality and regulatory processes, proactively identifying and mitigating potential issues.
• Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, clinical operations and commercial, to foster a culture of quality, innovation, and accountability.
• Continuous Improvement: Drive initiatives to enhance quality systems, streamline processes, and maintain compliance with evolving regulatory standards.

About You

• Experience: Minimum of 5 years’ experience in quality and regulatory affairs within the biotechnology, pharmaceutical, or medical device industry, with a proven track record of implementing QMS and achieving quality and regulatory objectives.
• Technical Expertise: In-depth knowledge of ISO17025, ISO13485, cGMP, and FDA regulatory pathways (PMA, CE-IVD, IND, NDA). Experience with global regulators and their frameworks (g., FDA, EMA, TGA, other) is highly desirable.
• Skills:
  • Exceptional attention to detail and organizational skills.
  • Strong analytical and problem-solving abilities, with a focus on risk management and continuous improvement.
  • Excellent communication and interpersonal skills to collaborate effectively with internal teams and external stakeholders.
  • Ability to manage multiple priorities in a fast-paced, innovative environment.
• Qualifications: Bachelor’s degree in a relevant scientific or technical field (e.g., biotechnology, biomedical engineering, or related discipline). Advanced degrees or certifications (e.g., RAC, CQM) are advantageous.
• Personal Attributes: Proactive, results-oriented, and self-motivated, with a passion for advancing healthcare through quality and innovation.

Why Join INOVIQ?

• Impactful Work: Contribute to groundbreaking diagnostics and therapeutics that improve patient lives.
• Innovative Environment: Be part of a collaborative, forward-thinking team pushing the boundaries of exosome technology.
• Career Growth: Opportunity to grow within a rapidly expanding ASX-listed company with a global vision.
• Competitive Package: Attractive salary, performance-based incentives, and a supportive work culture.

How to Apply: Interested candidates should submit their resume and cover letter outlining relevant experience and qualifications to [email protected] by 31 October 2025.

Please Note: Only shortlisted candidates will be contacted.

INOVIQ Ltd is an equal opportunity employer committed to diversity and inclusion.