Senior Scientist I IA (Brisbane)

We are seeking a Senior Scientist to develop and validate immunoassays that support preclinical and clinical drug development. The ideal candidate has strong experience with ligand-binding assays for PK, ADA and biomarkers, particularly ADA and neutralizing antibody (NAb) assays. They can troubleshoot complex technical issues and have a solid understanding of GLP, GCP and GCLP standards.

Key Responsibilities:

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·         Design, develop, optimize and validate ADA and neutralizing antibody immunoassays on ELISA or MSD platforms.

·         Independently troubleshoot assay performance issues and implement solutions.

·         Lead method transfer, qualification and validation in line with regulatory guidelines (e.g., FDA, EMA, ICH M10).

·         Ensure all laboratory work complies with Good Laboratory Practice (GLP) and internal SOPs.

·         Maintain accurate experimental records, review data and contribute to technical reports.

·         Train and mentor junior scientists.

·         Work closely with project teams, study directors and QA to deliver studies on time and to a high standard.

·         Contribute to continuous improvement of laboratory processes, documentation and best practices.

·         Take part in scientific discussions, audits and client meetings as needed.

·         Perform other duties as required.

Required Qualifications:

·         PhD in immunology, biochemistry, analytical chemistry or a related field with 3+ years of relevant industry experience, or an MSc with 5+ years.

·         Proven experience developing and validating immunogenicity (ADA and NAb) methods in line with FDA and industry guidelines.

·         Experience developing and validating PK or biomarker assays is advantageous.

·         Strong troubleshooting skills, including root-cause identification.

·         In-depth knowledge of GLP, GCP and regulatory requirements (FDA, EMA, ICH M10).

·         Excellent documentation, data analysis and scientific communication skills.

·         Demonstrated ability to lead projects and support junior colleagues.

·         CRO or pharmaceutical experience is a plus.