Technical Specialist- Molecular Pathology

IU Health•Indianapolis, IN

11d•Onsite

About The Position

Indiana University Health is Indiana’s most comprehensive health system, with 16 hospitals and more than 34,000 team members serving patients across the state. Our laboratory system performs over 19 million tests annually and supports hospitals and physicians nationwide with advanced diagnostic services. 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.

Requirements

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: PCR methodologies (qPCR, RT-PCR, melt-curve analysis), Next-generation sequencing (NGS) platforms and workflows, Molecular assay validation and development
Knowledge of CLIA, CAP, and regulatory requirements for molecular diagnostics
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

Nice To Haves

Certification by ASCP (MB), AMT, or equivalent preferred
Strong understanding of bioinformatics pipelines and data analysis workflows preferred

Responsibilities

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
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)
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
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
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