Location
In office (Melbourne)
Overview
Company
Impact
Profile match
Founded in 2008, BioAgilytix provides contract services to pharmaceutical and biotech companies internationally. Its services include pharmacokinetics, immunogenicity, biomarkers, and cell-based assays supporting the development and release testin...
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/MSD for use in human and animal trials supported by 360biolabs
- Perform assays for research projects, preclinical studies and clinical trials.
- Assist in the production of standard operating procedures
- Maintain records 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
- 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.
- Participate in and actively contribute to technical discussions with clients
- Attend meetings and training associated with the work of 360biolabs
- Participate in training activities and attendance at seminars in the field of expertise
General Laboratory Duties
Laboratory Assay Work
Data Analysis, Reporting and Document Work
NATA Accreditation
Safety
Team Work
Client Interactions
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 techniques and assays (Essential)
- Experience in optimisation and validation of a range of biological assays including ELISA, MSD and other plate-based immunological 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 (Desirable)
- High motivation and enthusiasm for medical research and the progression of therapeutics and vaccines (Desirable)
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