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Related skills

glp hplc method development lcms lcms/ms

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 assistance in the optimisation, validation and conduct of bioanalytical assays for research, preclinical and clinical studies. Contributing to a high-quality team at 360biolabs complying with relevant standards, regulatory guidelines, and SOPs.

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.

    • NATA 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.

    • General Laboratory Duties

  • Order and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needs.
  • Support the preparation of goods for assay work.
  • Prepare worksheets.
  • Ensure laboratory equipment is cleaned, maintained and calibrated as required
  • Ensure good housekeeping in the laboratory

    • Laboratory Assay Work

  • Run assays under supervision.
  • Support the performance of assays according to relevant Quality guidelines.
  • Support the troubleshooting of assays.

    • Data Analysis, Reporting and Document Work

  • Maintain records (LIMS, database and paper) to levels consistent with relevant standards and industry expectations
  • Support the preparation of summary tables.

    • Professional Development

  • Attend meetings associated with bioanalytical chemistry or the 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 (Essential)
  • Honours or Masters in Chemistry or Analytical Chemistry or equivalent experience (Desirable)

    • 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 methods (Desirable)
  • Experience in method development and validation of LCMS and LCMS/MS methods (Desirable)
  • Experience in handling clinical samples and their analysis by bioanalytical methods (Desirable)
  • 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 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)

    • Additional Information

    For further questions about the role, please contact the 360biolabs Careers team (careers@360biolabs.com).

    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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