Senior Scientist - Biomarker Method Development

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