Senior Immunoassay Scientist - ADA/NAb Method Validation

Resolian Bioanalytics; Brisbane; Sur place; AUD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

GLP/GCP/GCLP training

Résumé du poste

Resolian Bioanalytics seeks a Senior Scientist to develop and validate immunoassays supporting preclinical and clinical drug development, with emphasis on ADA and neutralizing antibody (NAb) assays. You will troubleshoot complex assay issues and lead method transfers with regulatory alignment.

The ideal candidate has a PhD or MSc with relevant industry experience, strong GLP/GCP/GCLP knowledge, and proven immunogenicity assay development skills.

Qualifications

• PhD in immunology, biochemistry, analytical chemistry or a related field with 3+ years of industry experience, or MSc with 5+ years.
• Proven experience developing and validating immunogenicity (ADA and NAb) methods in line with FDA guidelines.
• Experience developing and validating PK or biomarker assays is advantageous.
• Strong troubleshooting skills, including root-cause identification.

Responsabilités

• 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 (FDA, EMA, ICH M10).
• Ensure GLP and internal SOP compliance for all laboratory work.
• Maintain accurate experimental records, review data and contribute to technical reports.
• Train and mentor junior scientists.
• Work 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 and documentation.
• Participate in scientific discussions, audits and client meetings as needed.

Description du poste

Resolian Bioanalytics seeks a Senior Scientist to develop and validate immunoassays supporting preclinical and clinical drug development, with emphasis on ADA and neutralizing antibody (NAb) assays. You will troubleshoot complex assay issues and lead method transfers with regulatory alignment.

The ideal candidate has a PhD or MSc with relevant industry experience, strong GLP/GCP/GCLP knowledge, and proven immunogenicity assay development skills.