Senior Scientist I - IA (Brisbane)

Resolian Bioanalytics; Brisbane; On-site; AUD 90,000 - 130,000; Full time

Benefits offered by this job

GLP/GCP/GCLP training

Job summary

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.

Responsibilities

• 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.

Job description

• · 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.