360biolabs is Australias most comprehensive qualityaccredited 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 qualitycontrolled 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 highquality collaborative R&D at 360biolabs for clients to comply with relevant standards regulatory guidelines and SOP requirements. This role will be supporting various biology teams across the organisation.
Key Responsibility Areas
The key responsibility areas (KRAs) are the major outputs for which the position is responsible and are not a comprehensive statement of the 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 ELISA for use in human and 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 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 qualitycontrolled 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)
For 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 likeminded 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.
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