Clinical Laboratory Manager

Job Description

Job Description

Clinical Laboratory Manager, Houston, TX

Accountability:

Responsible for establishing, implementing, and managing the Houston, TX clinical laboratory and for hands-on execution of the AssureMDx clinical testing workflow, ensuring laboratory operations are performed in accordance with validated procedures, the laboratory Quality Management System, CLIA requirements, and CAP accreditation standards.

Position Summary: 

Vesica Health, part of the Photocure Group, is focused on advancing molecular diagnostics in bladder cancer, including AssureMDx, a urine-based molecular diagnostic test designed to support the evaluation of patients with hematuria for bladder cancer. 

This is an onsite position, 5 days in the lab at our location: 

2710 Reed Road, Suite 150

Houston, TX 77051

The Clinical Laboratory Manager / Senior Clinical Laboratory Scientist will have a unique opportunity to help build and launch Vesica Health’s clinical molecular diagnostics laboratory in Houston, TX and play a key role in bringing AssureMDx into routine clinical testing. This hands-on position combines laboratory setup and management with direct execution of clinical laboratory testing.

The role will support facility and equipment readiness, implementation of SOPs and the Quality Management System, assay technology transfer and validation, and readiness for CLIA certification and CAP accreditation. Once operational, the position will perform routine AssureMDx testing, including specimen accessioning and processing, molecular testing, quality control, and required laboratory documentation.

Initially, the position will work extensively at the bench in a lean laboratory environment while also managing day-to-day laboratory operations. As testing volumes grow, the role will have the opportunity to build, develop, and lead an expanding laboratory team.

Responsibilities and Activities:

Must Have

·       Must meet applicable CLIA personnel qualification requirements for performing high-complexity testing and applicable CAP personnel requirements for the testing performed.

·       Strong hands-on experience in a CLIA-regulated clinical molecular laboratory, preferably performing high-complexity molecular testing.

·       Demonstrated ability to independently perform molecular diagnostic laboratory procedures.

·       Experience with clinical specimen accessioning, sample preparation, nucleic acid extraction, PCR/qPCR, Next Generation Sequencing (NGS) and molecular assay workflows.

·       Experience working within a laboratory Quality Management System.

·       Experience working with controlled SOPs, laboratory documentation, quality control, equipment maintenance/calibration, deviations and CAPA.

·       Experience with laboratory validation or verification studies and assay implementation.

·       Ability to troubleshoot laboratory processes, instruments, reagents, and assay-performance issues.

·       Ability and willingness to work hands-on at the bench and routinely process clinical samples, particularly during the initial laboratory startup and early commercialization phases.

·       Strong attention to detail, documentation, data integrity, and specimen traceability.

·       Ability to work independently in a small laboratory environment while coordinating effectively with the Laboratory Director, Quality, R&D, Scientific Affairs, and external partners.

·       Must meet all applicable CLIA/CAP personnel qualification requirements for the complexity and responsibilities of testing assigned to the position.

Preferred

·       Proven ability to establish or launch a new clinical molecular laboratory.

·       Familiarity with CLIA certification and CAP accreditation readiness, including preparation for laboratory inspections.

·       Previous supervisory, lead scientist, or laboratory management responsibilities.

·       Demonstrated ability to develop, implement, and maintain SOPs and quality-system documentation.

·       Background in molecular oncology and/or cancer diagnostic testing.

·       Hands-on knowledge of DNA methylation assays.

·       Strong technical proficiency in NGS library preparation and targeted NGS workflows.

·       Familiarity with Illumina sequencing platforms, workflows, and associated laboratory QC methods.

·       Working knowledge of Laboratory Information Management Systems (LIMS) and electronic Quality Management Systems (eQMS).

·       Demonstrated ability to scale clinical laboratory operations from initial launch through increasing commercial testing volumes.

Education and Experience Needed:

Required

• Bachelor's degree or higher in a chemical, biological, clinical or medical laboratory science, medical technology, or another qualifying laboratory science from an accredited institution. Candidate must meet applicable CLIA personnel qualification requirements for performing high-complexity testing and applicable CAP personnel requirements for the testing performed.
• Demonstrated professional experience performing molecular testing in a regulated clinical laboratory environment.
• Demonstrated experience with laboratory quality systems, SOP-controlled work, clinical documentation, quality control, and regulated laboratory procedures.
• Experience performing high-complexity molecular testing strongly preferred given the AssureMDx clinical workflow.

Preferred

• Master's degree or PhD in molecular biology, genetics, clinical laboratory science, medical laboratory science, or a related discipline.
• ASCP certification (e.g., MLS or MB) or another relevant professional laboratory certification.
• Previous lead, supervisory, or laboratory-management experience.
• Experience with CLIA/CAP laboratory startup, inspection, accreditation, audit, or remediation activities.
• Experience transferring and validating a molecular LDT into clinical laboratory operations.
• Strong hands-on experience with PCR/qPCR, DNA methylation assays, NGS library preparation, and targeted sequencing workflows.