Senior Biomarker Assay Development Specialist (Remote)

About the role

A fully remote Senior Biomarker Assay Development Specialist is sought to support the development, optimization, validation and evaluation of biomarker assays for biotechnology, pharmaceutical research and clinical development projects. The role reviews assay performance data, assesses analytical methods, interprets biomarker results and prepares technical documentation to ensure reliable and reproducible scientific outcomes.

Key responsibilities

• Review biomarker assay development plans, analytical methods and performance data, and evaluate sensitivity, specificity, precision, accuracy, reproducibility and analytical range.
• Support remote assessment of immunoassays, ligand-binding assays, molecular assays and other biomarker platforms.
• Analyze assay validation results and identify sources of variability or measurement bias.
• Review experimental datasets, quality control results and method comparison studies.
• Recommend assay optimization strategies and improvements to analytical robustness.
• Collaborate remotely with biomarker scientists, bioanalytical teams, statisticians and clinical research professionals.
• Prepare technical reports, validation summaries, method assessment documents and scientific presentations.
• Support deviation reviews, risk assessments and CAPA documentation where applicable.
• Monitor emerging biomarker technologies, analytical methodologies and industry standards.

Required profile

• Bachelor's or master's degree in biochemistry, molecular biology, biotechnology, analytical chemistry, biomedical science or a related discipline; a PhD is an advantage.
• Significant experience in biomarker assay development, bioanalytical method validation or analytical research.
• Experience reviewing technical documentation, interpreting complex datasets and preparing scientific reports.
• Ability to work independently and collaborate across multidisciplinary teams in a fully remote environment.

Required skills

• Knowledge of assay performance characteristics, experimental design and statistical evaluation of analytical data.
• Familiarity with ELISA, multiplex immunoassays, ligand-binding assays, PCR-based assays or similar platforms.
• Understanding of assay validation principles and applicable quality or regulatory guidance.
• Strong analytical, problem-solving, communication and project coordination skills.