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.

In this role, we will rely on you to:

• 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

To qualify specifically for this role, you will have:

• Bachelor’s, Master’s, or PhD in Biology, Biochemistry, Immunology, or related scientific field with at least 5 years of experience in a bioanalytical laboratory environment
• Demonstrated depth of experience in biomarker method development, including the development, optimization, and troubleshooting of biomarker assays
• Strong hands-on experience with ligand binding assays (LBA), including ELISA, MSD, or similar immunoassay platforms
• Demonstrated ability to independently design experiments, evaluate assay performance, troubleshoot complex technical challenges, and optimize assay conditions
• Strong understanding of assay performance characteristics, including precision, accuracy, sensitivity, selectivity, specificity, and robustness
• Experience with method development, qualification, and/or validation in a regulated bioanalytical, pharmaceutical, biotechnology, or CRO environment
• Strong scientific judgment and the ability to interpret complex data and make recommendations based on experimental outcomes
• Experience working within established regulatory and quality frameworks applicable to bioanalytical method development
• Strong written and verbal communication skills with the ability to communicate complex scientific information to internal and external stakeholders
• Ability to provide technical guidance, training, and mentorship to less experienced scientific staff 

Preferred Qualifications:

• 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