Laboratory Operations Manager

DELFI Diagnostics, Inc. • Palo Alto, CA

7d • $145,000 - $165,000

About The Position

In this role, you will be responsible for the leadership and support of the daily laboratory operations, to and including the management of the staff. The Laboratory Operations Manager also performs high complexity laboratory testing directly for cancer detection via next generation sequencing. The Laboratory Operation Manager will be the first point of contact for troubleshooting technical issues. You will be responsible for maintaining operations and meeting project deliverables for laboratory programs such as the Equipment Management and Reagent Management programs. You will be working in a cross-functional capacity between the Clinical Laboratory, Client Services, Quality and Regulatory, the Laboratory Director, and other teams (e.g., Assay Development and Software Engineering). Given the wide variety of tasks involved in this position, the Laboratory Operation Manager must demonstrate the ability to analyze complex issues and make sound decisions in a timely manner, commit to providing the highest quality test results, work cross-functionally, and adapt quickly to evolving circumstances.

Requirements

• Must possess an active and valid Clinical Laboratory Scientist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS) license issued by the state of California pursuant to Division 2, Chapter 3 of the California Business and Professions Code or to practice medicine, osteopathy, or podiatry pursuant to Division 2,
• Chapter 5 of the California Business and Professions Code appropriate to the specialty being performed
• Must fulfill requirements stated in Title 17 California Code of Regulations Section 1036.1
• Must fulfill requirements stated in 42 CFR 493.1461 or 493.1462
• Must fulfill requirements stated in the College of American Pathologists Molecular Pathology Checklists
• Previous leadership/management experience
• BS in Biomedical Laboratory Sciences, Clinical Science, or equivalent

Nice To Haves

• 6+ years of Clinical Laboratory experience or equivalent high complexity and volume laboratory experience
• Laboratory experience within the last year
• Experience with next-generation sequencing, molecular biology techniques and automated liquid handlers
• Working knowledge of local, state, and federal laboratory regulations

Responsibilities

• Provide day-to-day leadership/management of laboratory operations including but not limited to: leading/coaching/mentoring/managing the employees,performing patient testing, reviewing QC records, leading on Quality events, supporting the Equipment and Reagent programs, and/or monitoring the ongoing test performance indices per applicable regulatory requirements.
• Create, execute, develop, implement, maintain, and continuously improve the laboratory's policies, procedures, and workflow to ensure efficient operations in a compliant environment.
• Support cross-functional teams in implementing new products, improving processes, and troubleshooting activities. Represent the Clinical Lab department in cross-functional meetings.
• Participate in organizational compliance with all applicable regulatory and company procedures by providing feedback, training, and education.
• Perform testing and validation of new laboratory equipment and procedures. Identify and implement process improvement opportunities.
• Train new and existing laboratory personnel on current and new procedures.
• Communicate to the Laboratory Director and/or Senior Director, Laboratory Operations regarding any issues, and specimen and process troubleshooting.
• All other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 101-250 employees