Clinical Laboratory Manager

Photocure•Houston, TX

1d•Onsite

About The Position

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. The Clinical Laboratory Manager / Senior Clinical Laboratory Scientist will help build and launch Vesica Health’s clinical molecular diagnostics laboratory in Houston, Texas, and support the introduction of AssureMDx into routine clinical testing. This hands-on role combines laboratory setup and management with direct execution of clinical laboratory testing. The position supports facility and equipment readiness, SOP and Quality Management System implementation, assay technology transfer and validation, and readiness for CLIA certification and CAP accreditation. Once the laboratory is operational, the position performs routine AssureMDx testing, including specimen accessioning and processing, molecular testing, quality control, and required documentation. Initially, the role will work extensively at the bench in a lean laboratory environment while managing day-to-day operations. As testing volumes grow, the position may build, develop, and lead an expanding laboratory team. This is an onsite position, five days per week, at 2710 Reed Road, Suite 150, Houston, TX 77051.

Requirements

Meet applicable CLIA personnel qualification requirements for performing high-complexity testing and applicable CAP personnel requirements for the testing performed.
Bachelor's degree or higher in chemical, biological, clinical or medical laboratory science, medical technology, or another qualifying laboratory science from an accredited institution.
Demonstrated professional experience performing molecular testing in a regulated clinical laboratory environment.
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 with controlled SOPs, laboratory documentation, quality control, equipment maintenance and 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.
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.

Nice To Haves

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.
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.
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.

Responsibilities

Establish, implement, and manage the Houston clinical laboratory.
Perform the AssureMDx clinical testing workflow in accordance with validated procedures, the laboratory Quality Management System, CLIA requirements, and CAP accreditation standards.
Support facility and equipment readiness for laboratory operations.
Implement SOPs and the Quality Management System.
Support assay technology transfer and validation.
Support readiness for CLIA certification and CAP accreditation.
Perform routine AssureMDx testing, including specimen accessioning and processing, molecular testing, quality control, and required laboratory documentation.
Work hands-on at the bench and routinely process clinical samples, particularly during laboratory startup and early commercialization.
Manage day-to-day laboratory operations.
As testing volumes grow, build, develop, and lead an expanding laboratory team.