Scientist - R&D

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients.

With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives. Labcorp is seeking a Scientist I – R&D to join our team in RTP, NC!

• Assay Development & Validation
• Support development, optimization, and implementation of molecular diagnostic assays utilizing NGS technologies.
• Design and execute assay verification and validation studies for germline and somatic testing applications.
• Generate validation protocols, study plans, and final validation reports in accordance with applicable regulatory and quality requirements.
• Perform analytical studies evaluating sensitivity, specificity, precision, accuracy, reproducibility, limit of detection, and other performance characteristics.
• Assist in technology transfer activities from R&D to clinical laboratory operations.
• Data Analysis & Interpretation
• Analyze and interpret NGS assay performance data.
• Evaluate sequencing quality metrics, assay performance indicators, and validation study results.
• Summarize findings and present recommendations to project stakeholders.
• Maintain accurate records of experimental designs, results, analyses, and conclusions.
• Documentation & Compliance
• Prepare technical documentation including:
  Validation protocols Validation reports Standard Operating Procedures (SOPs) Technical summaries Risk assessments
• Ensure documentation is accurate, complete, and compliant with laboratory quality standards.
• Assist in developing and maintaining design history and validation documents.
• Collaboration & Continuous Improvement
• Collaborate with cross-functional teams including Bioinformatics, Clinical Laboratory, Quality Assurance, Regulatory Affairs, and Operations.
• Participate in troubleshooting assay performance issues and identifying process improvements.
• Stay current with advancements in molecular diagnostics, genomics, and NGS technologies.
• Represent R&D at Core Team project meetings, ensuring clear communication of project priorities, timelines, status, and cross-functional alignment.

• Bachelor of Science degree in Molecular Biology, Genetics, Genomics, Bioinformatics, Biotechnology, or Biomedical Sciences with 5 or more years of experience in molecular diagnostics, genomics, or biotechnology OR PhD with 2 or more years of experience in molecular diagnostics, genomics, or biotechnology.
• 3 or more years of experience with Next-Generation Sequencing workflows and technologies.

• 5 or more years of experience with validation of molecular diagnostic assays.
• 1 or more years of experience in bioinformatics including NGS data analysis pipelines and variant interpretation.
• 2 or more years of experience with somatic oncology testing or hereditary disease testing.
• 1 or more years of experience in statistical analysis using R, Python, JMP, or Minitab.

• Strong data analysis and problem-solving skills.
• Ability to prepare detailed technical documentation and validation…