Scientist (pk)

360biolabs is Australia's most comprehensive quality-accredited specialty laboratory services organisation. 360biolabs is a BioAgilytix company and part of a leading global contract research organisation (CRO) supporting the development of innovative new medicines in a quality-controlled environment. At 360biolabs, we develop and conduct pharmacokinetics (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas to ensure the success of our clients' clinical trials and preclinical studies.

The duties of this role are to provide scientific expertise and assistance in the development, validation, and conduct of biological assays for research, preclinical and clinical studies. Conduct high-quality collaborative R&D at 360biolabs for clients to comply with relevant standards, regulatory guidelines and SOP requirements.

Key Responsibility Areas

• The key responsibility areas (KRAs) are the major outputs for which the position is responsible and are not a comprehensive statement ofthe position activities. Safety- Ensure the safe and efficient conduct of laboratory activities
• Ensure compliance to relevant internal processes and statutory requirements Team Work- Maintain high levels of communication with colleagues and productive relationships with service providers and other partners. NATA Accreditation- Adhere to ISO/IEC 17025, OECD Principles of GLP, GCLP/GCP Principles,
• 360biolabs’ Quality Management System, and other requirements as per NATA
• Accreditation and regulatory guidelines General Laboratory Duties- Order and maintain supplies for the laboratories
• Obtain quotes for relevant supplies
• Ensure laboratory equipment is cleaned, maintained and calibrated as required
• Ensure good housekeeping in the laboratory Laboratory Assay Work- Develop, optimise and validate biological assays, particularly a range of immunology techniques and other assays including cytokine profiling and ELISA for use in humannand animal trials supported by 360biolabs
• Perform assays for research projects, preclinical studies and clinical trials. Data Analysis, Reporting and Document Work- Prepare and review policies, SOPs, systems and procedures to assure the quality and integrity of service offerings at 360biolabs
• Maintain records (LIMS, database and paper) to levels consistent with relevant standards and industry expectations
• Perform data analysis, presentation and interpretation where appropriate
• Assist in the production of both internal reports and reports for clients Client Interactions- Participate in and actively contribute to technical discussions with clients Professional Development- Attend meetings and training associated with the work of 360biolabs
• Participate in training activities and attendance at seminars in the field of expertise
• Maintain awareness of new assay technologies and other developments relevant to clinical assay validation and development and make recommendations for improvements

Key Selection Criteria

• BSc (Hon) in a Biological Discipline plus relevant experience (Essential)
• PhD in a Biological discipline or equivalent experience (Desirable)
• Experience in a Clinical Research Organisation (Essential)

Experience / Knowledge / Attributes

• Experience in medical laboratory techniques for the role required (Essential)
• Excellent organisational and writing skills (Essential)
• Ability to work as part of a team (Essential)
• Strong background and proven experience in molecular biology techniques and immunological and molecular assays (Essential)
• Experience in optimisation and validation of a range of biological assays including cellular, cytokine and molecular assays (Essential)
• Experience in handling clinical samples and their analysis by various techniques (Essential)
• Experience in testing therapeutic drugs, immunotherapies and/or vaccines preferably in an industry or contract research environment (Desirable)
• Experience in the conduct of early phase clinical trials (Desirable)
• Experience working in a quality-controlled environment preferably an accredited facility following ISO/IEC 17025, GLP or similar
• High motivation and enthusiasm for medical research and the progression of therapeutics and vaccines (Desirable)