Genalyte, Inc. · 2 weeks ago
Clinical Laboratory Scientist
San Diego, CA
Full-time
Onsite
Mid Level
$38/hr - $54/hrGenalyte, Inc. is revolutionizing diagnostic testing to empower a healthier future. The Clinical Laboratory Scientist will independently perform high-complexity clinical testing, support assay quality and instrument performance, and contribute to workflow optimization.
BiotechnologyHealth CareHospitalReal Time
Responsibilities
Perform hematology and clinical chemistry diagnostic testing in accordance with CLIA, SOPs, and quality management systems
Perform phlebotomy, collection and processing of patient samples by obtaining blood specimens through venipuncture and fingerstick
Maintains specimen integrity by using aseptic technique, following department procedures; observing isolation procedures
Document all QC activities, maintenance, calibrations, and corrective actions
Troubleshoot routine and complex assay/instrument issues and serve as a subject matter expert
Lead process improvement initiatives, including workflow efficiency, TAT improvements, and cost-saving efforts
Participate in proficiency testing, regulatory inspection readiness, and quality committee initiatives
Support assay validation projects and contribute to development and revision of SOPs
Train and assess competencies of testing personnel and support expansion of laboratory capabilities
Meet milestones for product development timelines
Work as part of a multi-disciplinary team with other chemists, data scientists, engineers and manufacturing personnel
Maintain compliance with all company policies, quality systems, design control and procedures
Document results, protocols, SOPs, etc
Supports product improvement and manufacturing optimization
Perform review of clinical data listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager/Study Lead as needed
Proactively and effectively communicate the status of clinical studies to management
Participate in the interim and final reviews of study data in preparation of regulatory submissions
May interact with RA/QA in responding to audits and FDA inquiries
Assist senior staff in development of study-specific forms and trial-specific monitoring plans
Qualification
Required
Active California CLS or CGMBS license (required)
Must possess a valid CA phlebotomy certification
Bachelor's degree in a chemical, biological, physical, or clinical lab science (or qualifying equivalent)
Strong analytical, troubleshooting, and technological skills
Excellent communication, teamwork, and adaptability in a fast-paced lab environment
Ability to maintain required CE units for state licensure
Proficient with Google Workspace
Preferred
Experience with high-complexity testing; molecular methods (PCR, microarray, Sanger/NGS) highly preferred
Experience working on medical device studies and/or in-vitro diagnostics studies preferred
Benefits
Health, dental, and vision insurance
Generous paid time off
Stock ownership and equity participation
Participation in our annual target bonus plan
Company
Genalyte, Inc.
Genalyte delivers accurate, real-time blood diagnostics at the point of care. For more information, visit www.genalyte.com.
Founded in 2007
51-200 employees
H1B Sponsorship
Genalyte, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)
2021 (4)
2020 (3)
Funding
Current Stage
Growth StageTotal Funding
$154.8MKey Investors
VerilyKhosla VenturesClaremont Creek Ventures
2023-03-07Series C· $13M
2021-01-11Series Unknown· $50M
2016-11-20Series D· $36M
Leadership Team
R
Rufus Burlingame
VP Clinical Assay Development
Cary Gunn
Founder
Recent News
2025-05-29
2025-04-02
Google Patent
2025-02-08
Company data provided by crunchbase