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
