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We are seeking a Senior Bioanalytical Scientist with deep expertise in immunoassay method development and validation to support preclinical and clinical drug development. The ideal candidate will have a strong technical background in ligand-binding assays (e.g., ELISA, MSD), experience in troubleshooting complex technical issues, and a solid understanding of GLP / GCP standards. This role also includes mentoring and training junior scientists while driving scientific excellence and continuous improvement.
Responsibilities :
Design, develop, optimize, and validate immunoassays (e.g., ELISA, MSD) for pharmacokinetic (PK), biomarker, and immunogenicity (ADA / NAb) studies.Independently troubleshoot assay performance issues and implement effective solutions.Lead method transfers, qualification, and validation activities in accordance with regulatory guidelines (e.g., FDA, EMA, ICH M10).Ensure all laboratory work adheres to Good Laboratory Practice (GLP) and internal SOPs.Maintain accurate and detailed experimental records, review data, and contribute to technical reports.Train and mentor junior scientists, supporting their technical and professional growth.Collaborate closely with project teams, study directors, and QA to ensure timely and high-quality study delivery.Actively contribute to continuous improvement in lab processes, documentation, and best practices.Participate in scientific discussions, audits, and client meetings as needed.Other tasks as required.Skills, Education & Qualifications
Ph.D. in immunology, biochemistry, analytical chemistry, or related field with 3+ years of relevant industry experience, or M.Sc. with 5+ years.Proven experience in immunoassay method development and validation (ELISA, MSD, or similar platforms).Strong troubleshooting skills with the ability to identify root causes and implement solutions.In-depth understanding 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 team members.Experience working in a CRO or pharmaceutical environment is a plus.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionScience and ResearchIndustriesBiotechnology Research and Research ServicesReferrals increase your chances of interviewing at Resolian by 2x
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Scientist • Australia