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.
Provide scientific expertise and leadership in the development, validation, and conduct of bioanalytical assays for research, preclinical and clinical studies. Conduct high-quality collaborative R&D at 360biolabs for clients to comply with relevant international 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. Ensure the safe and efficient conduct of laboratory activitiesEnsure compliance to relevant internal processes and statutory requirementsMaintain high levels of communication with colleagues and productive relationships with service providers and other partners.Adhere to ISO/IEC 17025, ISO 15189, OECD Principles of GLP, GCLP Principles, 360biolabs’ Quality Management System, and other requirements as per NATA Accreditation and regulatory guidelines.Order and maintain supplies for the laboratoriesObtain quotes for relevant suppliesEnsure laboratory equipment is cleaned, maintained and calibrated as requiredEnsure good housekeeping in the laboratoryDevelop, optimise and validate bioanalytical methods and assays, including LCMS, LCMS/MS and HPLC 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 360biolabsMaintain records (LIMS, database and paper) to levels consistent with relevant standards and industry expectationsPerform data analysis and provide clear interpretation of data to othersProduce and review reports (for example Validation Protocols, Validation Reports, Analytical Plans & Study Reports) and presentations for internal use and communication to clientsParticipate in and actively contribute to technical discussions with clientsAttend meetings associated with clinical trials, bioanalysis or the work of 360biolabs Participate in professional activities including attendance at conferences and seminars in the field of expertise
Key Selection Criteria
BSc in a Chemistry or related discipline (Essential)PhD in a Chemistry or Analytical Chemistry or equivalent experience (Essential)
Experience/ Knowledge/ Attributes
Experience in 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)Experience in method development and validation of HPLC, LCMS & LCMS/MS methods for the detection and quantitation of compounds from various matrices (Essential)Experience in handling clinical samples and their analysis by bioanalytical methods (Essential)Experience in testing drugs, small molecules, metabolites, peptides and/or proteins preferably in an industry or contract research environment (Desirable)Experience with database computer software and file management (Desirable)Experience in working in a quality-controlled environment preferably an accredited facility following ISO/IEC 17025, GLP or similar (Desirable)Experience in the conduct of early phase clinical trials (Desirable)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 ([email protected]).
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.
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.
