Clinical Laboratory Manager

Key Responsibilities

• Oversee daily laboratory operations related to cord blood and cord tissue processing, testing, cryopreservation, and release activities.
• Direct and supervise laboratory technologists, providing leadership, training, performance management, and professional development.
• Ensure accurate characterization of cellular products utilizing flow cytometry, hemacytometry, blood typing, and molecular testing methodologies.
• Review and approve laboratory data, test results, batch records, and associated documentation to ensure accuracy, completeness, and regulatory compliance.
• Provide technical expertise and troubleshooting support for laboratory processes, equipment, assays, and workflow challenges.
• Lead method validations, process qualifications, and implementation of new technologies and procedures.
• Develop, revise, and maintain standard operating procedures (SOPs), work instructions, and technical documentation.
• Monitor laboratory key performance indicators (KPIs), operational metrics, and quality indicators to drive continuous improvement initiatives.
• Investigate deviations, nonconformances, and quality events, and communicate findings and corrective actions to Laboratory Leadership and Quality Management.
• Partner with Quality Assurance to support audits, inspections, corrective and preventive actions (CAPAs), and regulatory submissions as required.
• Ensure adherence to all applicable laboratory safety, quality, and regulatory standards.

Required Qualifications

• Bachelor's degree in Medical Technology, Clinical Laboratory Science, Biology, Biotechnology, or any life science discipline.
• 5+ years of experience managing laboratory operations within a regulated environment.
• Operating and maintaining compliance with regulatory and accreditation requirements including the U.S. Food and Drug Administration (FDA) regulations, American Association of Blood Banks (AABB) Standards, Clinical Laboratory Improvement Amendments (CLIA), Current Good Tissue Practice (cGTP) and current Good Manufacturing Practice (cGMP) requirements.
• 10+ years of experience working in a laboratory using cellular therapy, cord blood banking, tissue processing, and/or cryopreservation practices.
• 10+ years of experience with flow cytometry, manual and automated cell counting techniques, blood typing, and molecular laboratory methods.
• OR Master's degree in Medical Technology, Clinical Laboratory Science, Biology, Biotechnology, or any life science discipline.
• 3+ years experience managing laboratory operations within a regulated environment.
• Operating and maintaining compliance with regulatory and accreditation requirements including the U.S. Food and Drug Administration (FDA) regulations, American Association of Blood Banks (AABB) Standards, Clinical Laboratory Improvement Amendments (CLIA), Current Good Tissue Practice (cGTP) and current Good Manufacturing Practice (cGMP) requirements.
• 5+ years experience working in a laboratory using cellular therapy, cord blood banking, tissue processing, and/or cryopreservation practices.
• 5+ years experience with flow cytometry, manual and automated cell counting techniques, blood typing, and molecular laboratory methods.

Preferred Qualifications

• Proven ability to lead technical staff, manage laboratory performance, and drive operational excellence.
• Excellent written and verbal communication skills, with experience developing technical procedures and presenting performance and quality data.