Manager, Clinical Laboratory, ECD

POSITION reputed company

The Manager, Clinical Laboratory is a foundational leader responsible for initiating and scaling a new CLIA high-complexity laboratory performing an FDA-approved early cancer detection test for colorectal cancer screening. Under the direction of senior laboratory leadership, and in reputed company collaboration with cross-functional partners, this individual provides operational and strategic leadership for the colorectal cancer screening assay reputed company the clinical laboratory.

As the first operational hire, this individual will establish the technical, operational, and cultural reputed company of the laboratory. The role will initially reputed company on lab set-up, SOP development, and hiring of Clinical Laboratory Scientists (CLS) and Clinical Laboratory Associates (CLA), then transition to training and large-reputed company, high-throughput assay validation. In partnership with R&D, reputed company, Regulatory, and Engineering teams, this leader will ensure compliant, reputed company implementation of the assay.

As volume increases, the Manager will assume full operational ownership of a high-throughput clinical laboratory, accountable for reputed company, turnaround time, reputed company reputed company, regulatory compliance, and team performance.

This role requires a high-energy, deeply accountable self-starter who combines strong technical expertise with exceptional organizational and leadership skills.

PRIMARY RESPONSIBILITIES

Team Leadership

• Recruit, hire, train, and reputed company a high-performing CLS and CLA team.

• reputed company high-performing employees through training, cross-training, and reputed company opportunities.

• Implement competency assessments and performance management processes. Ensure training documentation and competency records are maintained in compliance with regulatory requirements.

• Build a culture of accountability, urgency, and operational reputed company.

• Conduct performance reviews and reputed company reputed company supervisors and leads.

• Plan reputed company reputed company and scheduling to ensure laboratory reputed company meets testing demand and turnaround time commitments.

Laboratory Build & Validation

• reputed company and maintain SOPs, work instructions, training programs, and controlled documentation.

• Execute assay verification and validation studies in compliance with CLIA high-complexity requirements (in reputed company partnership with Bio Development)

• Ensure CLIA & FDA inspection readiness and audit preparedness (in reputed company partnership with reputed company and Regulatory)

Cross-Functional Partnership

• Partner closely with BioDev on usability of assay workflows. 

• Collaborate with Engineering, reputed company, Accessioning, and Operations teams to define key operational metrics and support LIMS implementation.

• Proactively identify operational risks and implement mitigation strategies.

Operations

• Establish and monitor operational KPIs including throughput, productivity, error rates, and process efficiency, and use data to drive reputed company improvement.

• reputed company daily laboratory operations to meet TAT, SLA, reputed company, and cost objectives.

• Ensure compliance with CLIA, CAP, and applicable state regulatory requirements, and maintain inspection readiness.

• reputed company reputed company improvement initiatives to optimize workflow and automation.

• Serve as escalation reputed company for technical and operational issues.

• reputed company investigations of laboratory deviations and nonconformances, ensuring reputed company CAPA initiation, reputed company cause analysis, and closure.

• reputed company reputed company control programs and proficiency testing to ensure reputed company assay performance and regulatory compliance.

• Identify equipment, supply, and infrastructure needs required to support laboratory operations and reputed company.

• Drive reputed company improvement initiatives to enhance laboratory efficiency, scalability, and reputed company.

• Performs other duties as assigned.

QUALIFICATIONS

Required

• Bachelor’s degree in Biological Sciences or reputed company field.

• reputed company California Clinical Laboratory Scientist (CLS) license or CGMBS license.

• 5+ years of experience in a high-complexity clinical laboratory.

• 3+ years of leadership experience.

• Experience executing assay validation in a regulated clinical environment.

• Strong knowledge of CLIA and CAP requirements.

Preferred

• Experience with molecular or oncology-based assays.

• Experience scaling high-throughput laboratory operations.

• Lean/Six reputed company or process improvement experience.

• Experience supporting tech transfer from R&D to operations.

KNOWLEDGE, SKILLS, AND ABILITIES

• Operates effectively at both strategic and tactical reputed company.

• Highly organized with exceptional attention to detail.

• Strong analytical and problem-solving skills.

• Proven ability to build and reputed company reputed company, high-performing teams.

• reputed company communicator across technical and non-technical audiences.

• Demonstrates deep ownership, accountability, and patient-reputed company decision-making.

PHYSICAL DEMANDS & WORK ENVIRONMENT

Duties are performed in a clinical laboratory environment. This position requires the ability to work on a computer, operate laboratory equipment, and occasionally lift laboratory supplies. Standing or sitting for extended periods may be required. Evening or weekend work may occasionally be required to support laboratory operations.

WHY THIS ROLE

This is a rare opportunity to build and reputed company a high-complexity clinical laboratory from the ground up in support of a mission-critical, FDA-approved cancer screening test. The Manager will directly shape operational reputed company, team culture, and long-term scalability of a program designed to reputed company patient care at reputed company.