The Manager will manage the day-to-day activities and operations of the cellular therapy laboratory area in accordance with professional and MLH standards of practice. Manages the laboratory to meet the cGMP requirements for minimally and more than minimally manipulated cellular therapy products. In collaboration with the Bone Marrow Transplant program leadership, the manager is responsible for the development and support of translational protocols for adult patients. Models appropriate behavior as exemplified in The Methodist Mission, Vision and Values.
Experience in performing minimal manipulation in Cord Blood, MUD and Haplo-transplants.
Advanced working knowledge of computers and software applications such as spreadsheets, word processing, and database applications.
Thorough knowledge of clinical laboratory practice, procedures, and regulatory standards gained through work experience in a clinical laboratory.
Detailed knowledge of all regulatory requirements including AABB, FACT, FDA.
Ability to understand and prepare complex written materials.
Ability to effectively communicate with all levels of Associates, management, physicians, and patients and their families.
Ability to lead and motivate individuals and groups of people toward the accomplishment of work and organizational goals.
Skill in negotiating with and between individuals and groups of people, including Associates, management and physicians.
Ability to plan and schedule tasks and projects and to maintain control of own and others’ work flow.
Ability to work without close supervision or professional guidance and to exercise independent judgment.
Ability to design, implement and complete projects.
Effective project planning and management skills.
Strong organizational, problem-solving and analytic skills.
Key Job Responsibilities:
Leadership & Direction:
Plans, organizes, implements, and controls laboratory activities and operations; monitors operations to ensure standards and objectives are being met; develops and implements limited or short-term plans to keep operations moving smoothly.
Plans and schedules work ensuring distribution of assignments and adequate staffing based on workload and productivity standards.
Manages the activities of professional Associates and Students; monitors Associates performance and clarifies work expectations, and assists with goal setting; promotes cooperation among individuals and groups. Develops and implements processes through orientation, training and education to ensure that the competence of all staff members is assessed, maintained, improved and demonstrated throughout their employment.
Develops and monitors expense budgets in the laboratory, authorizes expenditures. Assists in the development and implementation of capital budget and plans to control costs and improve department operations.
Investigates trends and developments in laboratory practice; introduces new procedures.
Ensures compliance with organizational policies for the laboratory. Interprets, executes, and recommends policy modifications.
Acts as primary trainer for LIS testing/training and development.
Provides leadership for educational programs for students and staff in collaboration with the laboratory administrative team.
Develops and maintains QA systems to ensure high level of performance and effective remedial actions to address deviations from performance specifications. Ensures documentation is maintained.
Oversees and reviews through active surveillance all quality control activities including daily QC, proficiency testing, instrument operation, technical performance, component processing. Ensures documentation is maintained.
Assigns, monitors and supervises work to ensure compliance with departmental SOPs and applicable federal, state and regulating agencies requirements including health/safety and patient confidentiality.
Oversees and manages all safety/occurrence reports including investigations, remedial actions according to department and hospital guidelines. Works with laboratory leadership as needed. Ensures documentation is maintained.
Ensures the laboratory is prepared for all regulatory reviews and inspections including Joint Commission, FACT, FDA. Responds to findings according to department timelines and ensures remedial actions are implemented and maintained.
Develops and implements procedures including SOP documentation, training and competency assessment according to department standards.
Coordinates clinical trials with principal investigators, study coordinators, quality assurance and compliance. Performs special projects including clinical trial involving cellular therapy products.
Supervision Provided by this Position:
Provides direct and/or indirect supervision for Associates and students in laboratory area
Bachelor’s degree in Medical Technology or a natural science from an accredited college sufficient to meet CLIA requirements. Minimum 6 years of progressively responsible experience with 1-3 years in a supervisory role. Demonstrated knowledge specific to the specialty. At least 3 years of experience in cellular therapies and cell processing. Must be currently licensed in the State of Tennessee as a Laboratory Supervisor OR must meet TN licensure requirements for Laboratory Supervisor and obtain within 90 days of hire. During the 90-day period, laboratory supervisor duties (as defined by the State) must be delegated to a licensed Laboratory Supervisor. AND Must have one of the following generalist or specialty certifications for the American Society for Clinical Pathology: MT(ASCP): Certification as Medical Technologist; MT(ASCP) BB: Certification in Blood Banking; MT(ASCP)SBB: Certification as a specialist in Blood Banking
Additional Salary Information: Commensurate with experience
Internal Number: 138755
About Methodist Le Bonheur Healthcare (University Hospital)
For the seventh year in a row, we have been named the Best Hospital in Memphis by U.S. News and World Report and were honored to be listed as one of the Commercial Appeal’s "Top Work Places" for 2015 for the fifth year in a row. We finished second in the large employer category of companies with more than 500 employees.
Methodist Le Bonheur Healthcare is an integrated, not-for-profit healthcare system based in Memphis, TN with locations and partners across the Mid-South. Throughout our history, we have remained affiliated with the United Methodist Church. Our faith inspire us to serve our patients and improve the health of our entire community.