Senior Immunoassay Scientist: Method Dev & Validation

Resolian Inc.; City of Brisbane; On-site; AUD 110,000 - 140,000; Full time

Job summary

Resolian Inc. is seeking an experienced scientist with a PhD or MSc in immunology/biochemistry/analytical chemistry to support regulatory-compliant laboratory work. You will develop and validate immunoassay methods, analyze data, and liaise with Sponsors to ensure timely, compliant study delivery.

The role requires independent execution of complex projects, strong communication skills, and a track record of maintaining high-quality, inspection-ready documentation in a GMP-like environment.

Qualifications

• Ph.D. with at least 3 years in immunology, biochemistry or analytical chemistry, or MSc with at least 5 years of experience.
• Experience developing/validating methods for pharmacokinetic and anti-drug antibody studies.
• Strong knowledge of GLP, GCP and 21 CFR Part 11 requirements.
• Excellent written and verbal communication; ability to work both collaboratively and independently.

Responsibilities

• Efficiently perform and document procedures, materials and results per regulatory standards.
• Independently execute method development, validation and qualification projects as needed.
• Prepare reagents, standards and control samples accurately and timely.
• Maintain inspection-ready laboratories and compliant documentation.
• Troubleshoot instruments and data issues; communicate findings to management.
• Collaborate with Sponsors and Regulators, ensuring timely data delivery.
• Review laboratory notebooks and reports for SOP and regulation compliance.

Skills

Communication skills

Teamwork

Analytical thinking

Time management

Education

Ph.D. in immunology/biochemistry/analytical chemistry

M.Sc. in immunology/biochemistry/analytical chemistry

Tools

ELISA

MSD platform

Job description

Resolian Inc. is seeking an experienced scientist with a PhD or MSc in immunology/biochemistry/analytical chemistry to support regulatory-compliant laboratory work. You will develop and validate immunoassay methods, analyze data, and liaise with Sponsors to ensure timely, compliant study delivery.

The role requires independent execution of complex projects, strong communication skills, and a track record of maintaining high-quality, inspection-ready documentation in a GMP-like environment.