Analysis Skills, Assay Development, Assays, Automation, Bioinformatics, Biology, Clinical Laboratory, Clinical Pathology, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Data Management, Data Quality, Documentation, Emerging Technology, Employee Assistance Plan, Employee Orientation, Genetics, Genomic Medicine, Genomics, Hospital, Identify Issues, Instrumentation, Interviewing Skills, Laboratory Systems, Laboratory Testing, Leadership, Maintain Compliance, Mentoring, Molecular Analysis, Molecular Biology, Next Generation Sequencing (NGS), Nucleic Acid, Pathology, Performance Analysis, Performance Metrics, Polymerase Chain Reaction (PCR), Process Improvement, Quality Assurance Methodology, Quality Control, Quality Management, Real-time PCR (qPCR), Regulations, Regulatory Compliance, Regulatory Requirements, Reverse Transcriptase PCR (RT-PCR), Standard Operating Procedures (SOP), State Laws and Regulations, Student Loans, Team Player, Technical Consulting, Technical Leadership, Test Plan/Schedule, Testing, Training Program Development, Training/Teaching, Workflow Analysis
Technical Specialist- Molecular Pathology
Job Description
Overview
Indiana University Health is Indianas 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.
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
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Qualifications
- Bachelors degree in Medical Technology, Molecular Biology, Genetics, or related biological science (Masters 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 Indianas #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
Equal Opportunity Employer
IU Health is an equal opportunity employer committed to diversity and inclusion. Reasonable accommodations are available for qualified individuals with disabilities.
We are an equal opportunity employer. IU Health does not discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and/or expression, marital status or any other characteristic protected by federal, state or local law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.