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 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.
- 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 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 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)
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
Skills Required
- BSc (Hon) in a Biological discipline plus relevant experience
- PhD in a Biological discipline OR equivalent experience
- Experience in medical laboratory techniques
- Excellent organisational and writing skills
- Ability to work as part of a team
- Good communication skills
- Strong background and proven experience in pharmacodynamic, immunogenicity and vaccine assays
- Experience in optimisation and validation of plate based immunogenicity and pharmacodynamic assays
- Experience in handling clinical samples and their analysis by various techniques
- Experience testing therapeutic drugs, immunotherapies and/or vaccines preferably in industry or a CRO
- Experience with database computer software and file management (e.g., LIMS)
- Experience in the conduct of early phase clinical trials
- Experience working in a quality-controlled, accredited facility (ISO/IEC 17025, GLP or similar)
- High motivation and enthusiasm for medical research and therapeutics/vaccines
What We Do
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory. BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.
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