Sr Scientist – Biomarker Method Development

When you work as a Sr. Scientist in the BioPharma Sciences group at KCAS, you get to further our mission by leveraging your knowledge in bioanalytical and scientific principles with a primary focus on biomarker method development. You will design, develop, optimize, and troubleshoot complex bioanalytical methods while utilizing your strong base in scientific principles and theories to assess assay performance, data integrity, and scientific outcomes.

Our BioPharma Sciences team uses ligand binding assay (LBA) platforms to conduct bioanalytical testing in support of drug discovery, preclinical, and clinical studies, including the quantification of proteins, biomarkers, and anti-drug antibodies in biological matrices using technologies such as ELISA, MSD, and other immunoassay-based methods.

Lead the design, development, optimization, and troubleshooting of ligand binding assays with a primary focus on biomarker method development

Design experiments and independently evaluate assay performance to establish robust and scientifically appropriate methods

Develop and optimize assay conditions, reagents, controls, and workflows to address complex biomarker method development challenges

Apply strong scientific judgment to evaluate assay performance characteristics, including precision, accuracy, sensitivity, selectivity, specificity, and robustness

Troubleshoot complex assay performance issues, identify root causes, and develop scientifically sound solutions

Support method qualification, validation, and transfer activities as appropriate for the intended use of the assay

Contribute scientific expertise to PK and immunogenicity/ADA method development activities as applicable

Act as a technical expert and scientific resource for biomarker assay development, performance, troubleshooting, and problem solving

Act as lead scientist, help design experiments, and provide work instructions and technical training to more junior scientific staff

Review and interpret scientific data and communicate findings, recommendations, and potential risks to internal teams and clients

Partner with clients and internal stakeholders to understand scientific objectives and translate those needs into appropriate bioanalytical strategies

Prepare and review study documentation, data summaries, protocols, and reports as appropriate

Work collaboratively with Quality Assurance and scientific teams to ensure activities are conducted in accordance with applicable protocols, SOPs, regulatory requirements, and quality standards

Maintain knowledge of current scientific, technological, and regulatory developments relevant to biomarkers and ligand binding assay development

Be responsible for timeline adherence and communication of status to management as required

Perform all aspects of the job in a way that supports company brand and supports company mission, vision, and values

Experience developing PK ligand binding assays

Experience developing immunogenicity/anti-drug antibody (ADA) assays

Experience working in a GLP-regulated bioanalytical laboratory environment

Experience interacting with Quality Assurance and supporting regulated studies, audits, or inspections

Experience in a CRO environment

Prior experience serving as a technical lead or scientific lead for assay development programs