The Opportunity: We are hiring a highly skilled and motivated Senior Scientist, Sample Management to join our Research & Clinical Bioanalytics (RCB) team at Bio21 Institute, in the heart of Melbourne's Biomedical Precinct. You will play a crucial role in ensuring compliance and efficiency in our sample management processes across all therapeutic areas and phases of development.
Reporting to the Manager of Compliance, you will: Lead and manage all sample and critical reagent activities within the RCB Bio21 department. Develop and implement effective sample management processes from bioanalytical laboratories to long-term storage. Ensure compliance with study protocols, informed consent forms, and regulatory frameworks. Collaborate with global RCB sites to align sample management processes. Act as the key contact for Clinical Development Operations to ensure effective sample management throughout the lifecycle. Oversee clinical samples at external bioanalytical laboratories. Develop sample management plans and coordinate sample shipments. Track and manage samples in long-term storage, ensuring compliance and proper handling. Manage contracts and budgets for long-term storage at external vendors. Participate in the Global Bioassays Management Committee (GBMC) and ensure compliance with accreditation/regulatory standards. Your Skills & Experience: Tertiary qualification in a scientific/medical/(bio)pharmaceutical discipline. Post-graduate qualification (Masters minimum) with at least 6 years of experience in pre-clinical and clinical development of biopharmaceuticals. Expert knowledge in compliant clinical sample management within a bioanalytical laboratory environment. Proficiency in Microsoft Office and laboratory management software (e.g., LIMS). Strong leadership skills and the ability to inspire and mentor a team. Broad perspective of the biopharmaceutical development process. How to Apply? Apply now to join a team dedicated to advancing scientific research! Please apply with your updated resume and cover letter by 15th November 2024.
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