Description:
We are seeking an experienced Senior Biomarker Assay Development Specialist to support the development, optimization, validation, and evaluation of biomarker assays for biotechnology, pharmaceutical research, and clinical development projects. This fully remote position focuses on reviewing assay performance data, assessing analytical methods, interpreting biomarker results, and preparing technical documentation to support reliable and reproducible scientific outcomes.
Key Responsibilities
- Review biomarker assay development plans, analytical methods, and performance data.
- Evaluate assay sensitivity, specificity, precision, accuracy, reproducibility, and analytical range.
- Support remote assessment of immunoassays, ligand-binding assays, molecular assays, and other relevant biomarker platforms.
- Analyze assay validation results and identify potential 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 corrective and preventive action (CAPA) documentation where applicable.
- Monitor emerging biomarker technologies, analytical methodologies, and relevant industry standards.
Qualifications and Experience
- 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.
- Knowledge of assay performance characteristics, experimental design, and statistical evaluation of analytical data.
- Familiarity with platforms such as ELISA, multiplex immunoassays, ligand-binding assays, PCR-based assays, or other relevant technologies.
- Understanding of assay validation principles and applicable quality or regulatory guidance.
- Experience reviewing technical documentation, interpreting complex datasets, and preparing scientific reports.
- Strong analytical, problem-solving, communication, and project coordination skills.
- Ability to work independently and collaborate effectively across multidisciplinary teams in a fully remote environment.