Scientist (PK)

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.

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

Laboratory Assay Work

Develop, optimise and validate biological assays, particularly a range of immunology techniques and other assays including cytokine profiling and ELISA for use in humannand animal trials supported by 360biolabs

Perform assays for research projects, preclinical studies and clinical trials.

Data Analysis, Reporting and Document Work

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

Client Interactions

Participate in and actively contribute to technical discussions with clients

NATA Accreditation

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

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.

Professional Development

Attend meetings and training associated with 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 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 assays (Essential)

Experience in optimisation and validation of a range of biological assays including pharmacokinetic and cytokine 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 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)