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.
\n Key Responsibility AreasThe 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 activitiesEnsure compliance to relevant internal processes and statutory requirementsTeam 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 guidelinesGeneral Laboratory Duties Order and maintain supplies for the laboratoriesObtain quotes for relevant suppliesEnsure laboratory equipment is cleaned, maintained and calibrated as requiredEnsure good housekeeping in the laboratoryLaboratory 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 human and animal trials supported by 360biolabsPerform 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 360biolabsMaintain records (LIMS, database and paper) to levels consistent with relevant standards and industry expectationsPerform data analysis, presentation and interpretation where appropriateAssist in the production of both internal reports and reports for clientsClient Interactions Participate in and actively contribute to technical discussions with clientsProfessional Development Attend meetings and training associated with the work of 360biolabsParticipate in training activities and attendance at seminars in the field of expertiseMaintain awareness of new assay technologies and other developments relevant to clinical assay validation and development and make recommendations for improvements Key Selection CriteriaBSc (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 / AttributesExperience 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 similarHigh motivation and enthusiasm for medical research and the progression of therapeutics and vaccines (Desirable)
\nFor further questions about the role, please contact the 360biolabs Careers team (******** ).
Apply now if you have what it takes to join our team!
360biolabs is a flexible, equal opportunity employer looking for committed and like-minded people to join us. Our culture is something we are very proud of, celebrating each individual and everything they bring to our team. We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQIA+ community and people with a disability.
Benefits of working with 360biolabs include working with the best people (and technology) in our field, local and global career opportunities and a genuine focus on wellbeing and connection., In addition, competitive remuneration packages will be offered to successful applicants based on skills and experience.
To express your interest in this position please submit a CV and cover letter. Applications only accepted from Australian / NZ residents with valid Australian work rights.