Laboratory Operations Manager

About Us

Our mission is to cure cancer through high performance, accessible early cancer detection. That means saving lives.

Delfi Diagnostics is a Johns Hopkins spinoff focused on the non-invasive detection of cancer at earlier stages, when it is most curable. DELFI uses artificial intelligence and whole genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients with cancer. These analyses are performed through simultaneous examination of millions of DNA sequences using machine learning to identify tumor-specific abnormalities.

In our passionate pursuit to radically improve health outcomes, we serve humanity when we:

Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.

Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class

Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.

About the Role

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.

What You'll Do:
• 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 You'll Have Accomplished 12 Months From Now:
• You will have participated in inspection activities, product validations, and launches in the Clinical Laboratory
• You will have contributed to areas for improvement in the Clinical Laboratory and operational scalability
• You will be a respected technical leader of the Clinical Laboratory, having contributed to the support of the laboratory and operations
• You will have acquired new expertise related to cancer genetics and whole genome sequencing technology, benefiting from mutual knowledge exchange with your colleagues

What You'll Bring to DELFI:
• Required
• 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
Preferred
• 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

An equal opportunity employer

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status