Lisa
Head Of Clinical Lab
- Role
- Head of Clinical Lab at Simple Healthkit
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
Experience
Head of Clinical Lab
Jan 2023 — Present
Led the buildout and launch of the clinical lab from the ground up, beginning in 2020. Continue to oversee all aspects of laboratory operations, regulatory compliance, and quality management, ensuring the delivery of high-quality, reliable diagnostic testing.Key responsibilities and accomplishments include- Built the CLIA-certified lab infrastructure from scratch, aligning it with business and clinical goals- Established and implemented a comprehensive CLIA-compliant Quality Management System (QMS), including internal audits, proficiency testing, and continuous improvement practices- Authored and maintained numerous Standard Operating Procedures (SOPs)- Successfully authored 5 New York Laboratory Developed Test (LDT) submissions- Provided critical support for FDA submissions related to diagnostic test offerings- Led assay development and validation for multiple diagnostic tests, ensuring analytical and clinical performance met regulatory and operational standards- Manage daily lab operations, including staffing, training, resource planning, and workflow optimization- Work closely with R&D, engineering, and executive leadership to align lab capabilities with product development and market strategy.
Education
San José State University
Master's degree, Biotechnology
2017 — 2019
Rutgers University
Bachelor of Science - BS, Biochemistry
2009 — 2013
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