Senior Scientist I - IA (Brisbane)

• · 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 clients, 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.

Requirements

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.

Summary

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.

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