Senior Biomarker Method Lead (LBA) - ELISA/Immunoassays

The Steely Group; Olathe (KS); On-site; USD 120,000 - 180,000; Full time

Job summary

The Steely Group is seeking a Sr. Scientist, Biomarker Method Development to design, optimize, and troubleshoot bioanalytical assays with a focus on biomarker methods.

You will work on ligand binding assays to support drug discovery and clinical studies using ELISA, MSD, and related immunoassays. You will lead method development, qualification, and transfer while mentoring junior staff and communicating findings to internal teams and clients.

Qualifications

• Bachelor's, Master's, or PhD in Biology, Biochemistry, Immunology, or related field with at least 5 years of experience in a bioanalytical laboratory environment.
• Deep biomarker method development experience including the development, optimization, and troubleshooting of biomarker assays.
• Hands-on experience with ligand binding assays (LBA), including ELISA, MSD, or similar immunoassay platforms.
• Experience with regulated bioanalytical environments and QA collaborations.

Responsibilities

• 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 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 translate scientific objectives into bioanalytical strategies.
• Prepare and review study documentation, data summaries, protocols, and reports as appropriate.
• Work with Quality Assurance to ensure activities meet protocols, SOPs, regulatory requirements, and quality standards.

Skills

Biomarker method development

LBA assays

ELISA

MSD

Experimental design

Data interpretation

Regulatory understanding

Mentorship

Education

Bachelor's/Master's/PhD in Biology/Immunology/Biochemistry

Tools

ELISA

MSD

Immunoassays

Job description

The Steely Group is seeking a Sr. Scientist, Biomarker Method Development to design, optimize, and troubleshoot bioanalytical assays with a focus on biomarker methods.

You will work on ligand binding assays to support drug discovery and clinical studies using ELISA, MSD, and related immunoassays. You will lead method development, qualification, and transfer while mentoring junior staff and communicating findings to internal teams and clients.