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.
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. Management, training and mentoring of staff.
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.
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 Pharmacodynamic, vaccine, immunogenicity ELISA/MSD plate based assays 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
ACCREDITATION
- Adhere to ISO/IEC 17025, OECD Principles of GLP, GCLP Principles, 360biolabs’ Quality Management System, and other requirements as per NATA Accreditation and regulatory guidelines.
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.
PROFESSIONAL DEVELOPMENT
- Attend meetings associated with clinical research or 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 / 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 pharmacodynamic, immunogenicity and vaccine assays (Essential)
- Experience in optimisation and validation of a range of plate based immunogenicity and pharmacodynamic 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 in 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.
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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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