Senior Clinical Laboratory Scientist

AlphaDetect is seeking a Clinical Laboratory Scientist/Senior Clinical Laboratory Scientist in Durham, NC

About the Client

In this position, you will be joining an exciting early phase opportunity with a vibrant, financially supported, not-for-profit laboratory startup in The Research Triangle, NC dedicated to rare disease detection. The ideal candidate will be integral in providing quality lab testing services to accelerate detection of the Alpha-1 Antitrypsin Deficiency (AATD) gene.

Overview

The Clinical Laboratory Scientist/Senior Clinical Laboratory Scientist performs immunoassay testing within the protein laboratory. This role oversees workflow coordination, quality systems and troubleshooting for protein-based and immunochemical assays, serving as a subject-matter expert for protein testing methodologies specific to Protein assays, DxC700, and experience in a high-complexity Chemistry laboratory doing protein assays. The position supports CLIA and other regulatory compliance requirements across pre-analytical, analytical, and post-analytical processes and partners closely with laboratory leadership to ensure accurate, timely, and compliant test results.

Principal Duties and Responsibilities

• Perform immunoassay testing in accordance with established procedures, regulatory standards, and competency requirements, including protein assays tested on the Beckman DxC700.
• Serve as a technical resource for protein assay performance, result interpretation, troubleshooting, and problem resolution.
• Support daily laboratory operations by maintaining efficient workflow, prioritizing testing activities, and ensuring appropriate staffing and shift coverage as assigned.
• Participate in competency assessments, proficiency testing, inspection readiness activities, and ongoing quality monitoring initiatives.
• Write, review, and maintain standard operating procedures (SOPs), validation documentation, quality records, and technical reports related to protein testing.
• Perform and document instrument maintenance, calibration, troubleshooting, and performance verification for protein analysis platforms and immunoassay instrumentation.
• Assist in the evaluation, validation, implementation, and documentation of new protein-based assays, methodologies, and technologies.
• Perform pre-analytical and post-analytical activities, including specimen processing, reagent preparation, inventory management, result review, verification, and reporting of routine and complex findings.
• Communicate technical and testing-related information clearly and professionally with laboratory staff, clinicians, and internal stakeholders.
• Adhere to laboratory safety standards, infection control policies, chemical hygiene plans, PPE requirements, and patient confidentiality regulations.