Clinical Laboratory Scientist

ABOUT GENALYTE 

At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.

WHY WORK FOR US 

We believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and generous paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career.

POSITION SUMMARY
The Clinical Laboratory Scientist will independently perform high-complexity clinical testing, support assay quality and instrument performance, and contribute to workflow optimization. This role also supports training, SOP development, assay validation, and cross-functional collaboration across QA, Data Management, Client Services, and Clinical Research.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to: 

• 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

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• 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).
• Experience with high-complexity testing; molecular methods (PCR, microarray, Sanger/NGS) highly preferred.
• 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.
• Experience working on medical device studies and/or in-vitro diagnostics studies preferred
• Proficient with Google Workspace

The base range for this role is $38.00 - $54.00 per hour. Individual pay may vary based on additional factors, including but not limited to, job-related skills, experience, work location, and relevant education or training. In addition to base salary, Genalyte provides generous benefits, equity opportunities, and for some roles, participation in our annual target bonus plan.