Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)Effectively demonstrates behaviors and performance characteristics as described in our core valuesDemonstrates full understanding of regulatory requirements (GLP, GCP, GMP, EPA, OECD, CLIA, 21CFR Part 11) and apply as required by operational areaDemonstrates effective communication skills through both informal and formal discussions with peers, supervisor, internal teams, across the organization, and externally with Regulators and SponsorsMaintain and demonstrate critical thinking, troubleshooting and time management skills aligned with the needs of the operational areaEnsures that operational area is clean and inspection ready at all timesIndependently and efficiently execute the completion of laboratory investigations, assay and equipment troubleshooting, and quality observations.
Effectively act as a technical resource for troubleshooting activitiesIndependently and accurately prepare reagents, standards and control samplesIndependently and accurately perform laboratory support functions such as labeling, monitoring expiration dates, and solution preparationIndependently and accurately execute routine sample analysis studies with increased throughput and workloadIndependently operate and maintain analytical instruments as required by operational areaIndependently and accurately perform data analysis in appropriate software for a majority of analytical platformsDemonstrates a complete understanding of what constitutes a passing or failed runDemonstrated ability to independently recognize method and/or data issues, communicate them to management,



and propose solutions to minimize study impactIndependently and accurately executes method validation and qualification projects with increased workload as required by operational areaIndependently designs and accurately executes complex method development projects as required by operational areaIndependently prepare accurate summaries of method development dataDemonstrates a complete understanding of compliance and regulations by independently and accurately writing both study and non-study deviationsIndependently and effectively function as a liaison, maintaining timely and frequent communication with the Sponsor as required by operational areaActively communicate and collaborate across operational areas in order to adhere to timelines and produce quality dataIndependently ensure the scientific integrity of studies as required by operational areaMaintains an awareness of team workload and routinely provides support to other staff membersIndependently and effectively review laboratory documents and notebooks (e.g., plans, experiment/sample runs, validation files, reports, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations as required by operational area.
Independently and accurately review system audit trails as required by operational area as neededSkills, Education & QualificationsPh.D.
degree with at least 3 years or M.Sc.
degree with at least 5 years of working experience in immunology, biochemistry or analytical chemistry (especially in quantitative immunoassay) or an equivalent combination of education, training, and experience as deemed appropriate by managementTechnic expertise in using ELISA or MSD platform to develop and validate methods for pharmacokinetic studies and anti-drug antibody studiesFamily with ICH M10 guidance is a plusThorough understanding of the requirements and applicability of GLP, GCP and 21 CFR Part 11.Ability to work effectively in a team and independentlyExcellent communication skills (writing and speaking).
Knowledge and understanding of the pharmaceutical industry; CRO working experience is desirable
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📌 Senior Scientist Immunoassay (Brisbane)
🏢 Resolian
📍 Brisbane