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Related skills

glp hplc pd iso 17025 lcms

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.

This role will provide scientific expertise and assistance in the optimisation, 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 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.

    • 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.

    • Quality Management System

  • Adhere to ISO/IEC 17025, OECD Principles of GLP, GCLP/GCP Principles
  • Adhere to 360biolabs’ Quality Management System, and other requirements as per NATA Accreditation and regulatory guidelines

    • 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

    • Technical Laboratory Duties

  • Conduct development and validation experiments for bioanalytical methods and assays, including LCMS, LCMS/MS, and HPLC for use in human and animal trials supported by 360biolabs
  • Perform assays for samples collected from research projects, preclinical studies and clinical trials.

    • Data Analysis, Reporting and Document Work

  • Assist in the preparation and review of policies, SOPs, systems and procedures to assure the quality and integrity of service offerings at 360biolabs
  • Maintain records (LIMS, database and experiment records) 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

    • Professional Development

  • Attend meetings and training associated with the the bioanalytical chemistry work of 360biolabs
  • Participate in training activities and attendance at seminars in the field of expertise

    • Key Selection Criteria

  • BSc in Chemistry or related discipline plus relevant experience (Essential)
  • PhD in Chemistry or Analytical Chemistry 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)
  • Experience in method development and validation of HPLC methods (Essential)
  • Experience in method development and validation of LCMS and LCMS/MS methods (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 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)

    • Additional Information

    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

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