Key skills
Leadership
About this role
Role Overview
- Recruit, hire, train, and develop a high-performing CLS and CLA team.
- Develop high-performing employees through training, cross-training, and growth opportunities.
- Implement competency assessments and performance management processes. Ensure training documentation and competency records are maintained in compliance with regulatory requirements.
- Build a culture of accountability, urgency, and operational excellence.
- Conduct performance reviews and develop future supervisors and leads.
- Plan staffing levels and scheduling to ensure laboratory capacity meets testing demand and turnaround time commitments.
- Develop and maintain SOPs, work instructions, training programs, and controlled documentation.
- Execute assay verification and validation studies in compliance with CLIA high-complexity requirements (in close partnership with Bio Development).
- Ensure CLIA & FDA inspection readiness and audit preparedness (in close partnership with Quality and Regulatory).
- Partner closely with BioDev on usability of assay workflows.
- Collaborate with Engineering, Bioinformatics, Accessioning, and Operations teams to define key operational metrics and support LIMS implementation.
- Proactively identify operational risks and implement mitigation strategies.
- Establish and monitor operational KPIs including throughput, productivity, error rates, and process efficiency, and use data to drive continuous improvement.
- Oversee daily laboratory operations to meet TAT, SLA, quality, and cost objectives.
- Ensure compliance with CLIA, CAP, and applicable state regulatory requirements, and maintain inspection readiness.
- Lead continuous improvement initiatives to optimize workflow and automation.
- Serve as escalation point for technical and operational issues.
- Lead investigations of laboratory deviations and nonconformances, ensuring timely CAPA initiation, root cause analysis, and closure.
- Oversee quality control programs and proficiency testing to ensure continued assay performance and regulatory compliance.
- Identify equipment, supply, and infrastructure needs required to support laboratory operations and scale.
- Drive continuous improvement initiatives to enhance laboratory efficiency, scalability, and quality.
Requirements
- Bachelor’s degree in Biological Sciences or related field.
- Current California Clinical Laboratory Scientist (CLS) license or CGMBS license.
- 5+ years of experience in a high-complexity clinical laboratory.
- 3+ years of leadership experience.
- Experience executing assay validation in a regulated clinical environment.
- Strong knowledge of CLIA and CAP requirements.
Benefits
- Annual performance incentive bonus
- Long-term equity awards
- Comprehensive health benefits (medical, dental, vision)
- 401(k) with company match
- Generous paid time off and company holidays
- Additional wellness and work-life benefits