Develop, optimise, validate and run PK/PD and immunological assays (ELISA, cytokine profiling) for preclinical and clinical studies. Maintain lab equipment, supplies and records (LIMS), ensure compliance with ISO/IEC 17025, GLP/GCLP/GCP and SOPs, analyse and report data, engage with clients, and contribute to quality and professional development activities.
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.
Working at 360biolabs means working with the best people (and technology) in our field. With a genuine focus on development, you will have access to local and global opportunities. You will also have access to a diverse offering of wellbeing and connection initiatives which reflects that people are our priority.
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 of the position activities.
- 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
- 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.
- 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
- Participate in and actively contribute to technical discussions with clients
- 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
- Ensure the safe and efficient conduct of laboratory activities
- Ensure compliance to relevant internal processes and statutory requirements
- Maintain high levels of communication with colleagues and productive relationships with service providers and other partners.
- 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
General Laboratory Duties
Laboratory Assay Work
Data Analysis, Reporting and Document Work
Client Interactions
NATA Accreditation
Safety
Team Work
Professional Development
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)
- Good communication skills (Essential)
- Strong background and proven experience in immunological assays (Essential)
- Experience in optimisation and validation of a range of biological assays including pharmacokinetic and cytokine 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 with database computer software and file management (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 (Desirable)
- High motivation and enthusiasm for medical research and the progression of therapeutics and vaccines (Desirable)
For further information, please contact our Careers Team ([email protected]). Please submit your application via the job link if you're interested in joining us, as we’re not able to process applications sent by email.
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.
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.
#360biolabs
BioAgilytix Melbourne, Victoria, AUS Office
85 Commercial Road, Melbourne, Australia
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