LIMS Software Product Manager

Kelly is seeking an experienced Software Product Manager to lead product ownership and execution for a Clarity LIMS platform within a regulated, high-throughput clinical Next-Generation Sequencing (NGS) environment. This role will drive roadmap execution, workflow optimization, feature development, system integrations, and regulatory alignment to support complex clinical laboratory operations.

Responsibilities:

• Own and execute the product roadmap for Clarity LIMS enhancements and optimization
• Translate clinical NGS workflows into clear product requirements, user stories, and acceptance criteria
• Prioritize and manage the Clarity backlog in partnership with engineering
• Lead sprint planning and ensure high-quality, on-time delivery in an agile environment
• Optimize workflows supporting high-throughput operations (sample intake, accessioning, batching, QC, sequencing, result tracking)
• Support integrations between LIMS, sequencing instruments, bioinformatics pipelines, and downstream reporting systems
• Ensure enhancements align with regulatory requirements (CLIA, CAP, GxP, 21 CFR Part 11 where applicable)
• Partner with Quality and Regulatory teams to support validation, documentation, change control, and audit readiness
• Serve as primary product liaison between Clinical Operations, Bioinformatics, Quality, Regulatory, and Engineering
• Facilitate prioritization and tradeoff discussions across stakeholders

Requirements:

• 5+ years managing full product lifecycle (concept to launch through iterative enhancement)
• 3+ years building and executing product roadmaps aligned with business objectives
• 3+ years collaborating directly with engineering teams to deliver roadmap-driven features
• 3+ years operating within agile product development environments
• Direct experience as a LIMS Software Product Manager
• Experience supporting regulated clinical laboratory environments (CLIA, CAP, GxP, or similar)
• Experience in high-throughput NGS operations
• Strong understanding of laboratory data lifecycle, sample tracking, QC workflows, sequencing operations, and compliance requirements
• Demonstrated ability to translate complex laboratory workflows into technical requirements
• Experience supporting system validation and change control processes
• Direct hands-on experience with Clarity LIMS
• Experience configuring and optimizing LIMS workflows
• Experience integrating LIMS with sequencing instruments and bioinformatics systems
• Experience scaling LIMS platforms in growing clinical laboratory environments
• Familiarity with molecular diagnostics or genomics testing operations