Job Description

The IU Health Molecular Pathology Laboratory is seeking a highly motivated Technical Laboratory Specialist with expertise in molecular diagnostics, including PCR, Sanger sequencing and next-generation sequencing (NGS). This role will provide technical oversight, quality assurance, and method development for high-complexity molecular testing in a clinically regulated environment.

Shift: Full-time, days

Location: IUHMG Molecular Pathology Lab (Indianapolis, IN)

Role Summary

The Molecular Pathology Technical Specialist is responsible for ensuring the accuracy, quality, and regulatory compliance of molecular diagnostic testing, with a focus on PCR-based assays, Sanger sequencing and NGS workflows. This role partners closely with medical directors, laboratory leadership, and quality teams to support cutting-edge genomic testing and continuous improvement initiatives.

Key Responsibilities

Technical Oversight & Testing
• Provide technical leadership for PCR (qPCR, RT-PCR, melt-curve analysis), Sanger sequencing and NGS platforms including assay performance, validation, and optimization
• Oversee end-to-end NGS workflows, including nucleic acid extraction, library preparation, sequencing, and data quality review
• Collaborate on the development, validation, and implementation of laboratory-developed tests (LDTs)
• Troubleshoot complex molecular assays, instrumentation, and bioinformatics pipelines

Quality Assurance & Compliance
• Ensure compliance with CLIA, CAP, and other regulatory standards for high-complexity molecular testing
• Establish and maintain quality control programs for PCR, Sanger and NGS assays
• Review and approve SOPs, validation reports, QC documentation, and test procedures
• Lead investigations into non-conformances, out-of-specification results, and corrective/preventive actions (CAPA)

Method Development & Validation
• Design and execute analytical validations for molecular assays (accuracy, precision, sensitivity, specificity, LOD)
• Evaluate and implement emerging molecular technologies and genomic platforms
• Collaborate with pathologists and clinical teams on test utilization and optimization

Training & Competency
• Develop and deliver training programs for staff in molecular techniques and workflows
• Manage competency assessments and technical qualification programs
• Provide mentorship and technical guidance to laboratory personnel

Continuous Improvement & Innovation
• Analyze assay performance metrics and implement process improvements
• Support digital and automation initiatives within molecular diagnostics
• Stay current with advances in molecular pathology, genomics, and precision medicine

Qualifications
• Bachelor's degree in Medical Technology, Molecular Biology, Genetics, or related biological science (Master's preferred)
• Meets CLIA requirements for Technical Consultant (TC) and Technical Supervisor (TS)
• Minimum 4 years of experience in high-complexity molecular laboratory testing
• Demonstrated experience with:

o PCR methodologies (qPCR, RT-PCR, melt-curve analysis)

o Next-generation sequencing (NGS) platforms and workflows

o Molecular assay validation and development
• Certification by ASCP (MB), AMT, or equivalent preferred
• Strong understanding of bioinformatics pipelines and data analysis workflows preferred
• Knowledge of CLIA, CAP, and regulatory requirements for molecular diagnostics

Skills & Competencies
• Expertise in molecular testing techniques and instrumentation
• Strong analytical and troubleshooting abilities
• Excellent documentation and regulatory compliance skills
• Ability to work collaboratively across multidisciplinary teams
• Familiarity with laboratory information systems (LIS) and data management tools

Benefits

As Indiana's #1 healthcare system, IU Health offers:
• Competitive compensation
• 401(k) with employer match
• Tuition reimbursement
• Student loan forgiveness programs
• Employee Assistance Program
• Wellness incentives and rewards