Lab Manager - Cell Processing Lab

Novant Health • Charlotte, NC

73d

About The Position

The Cell Processing Lab Manager is an integral leader within our growing cross-market Transplantation and Cellular Therapy Program. Oversees all aspects of the Novant Health Weisiger Stem & Immunotherapy Lab including processing, cryopreservation, storage, and thawing of peripheral blood stem cells, lymphocytes, and other cellular therapy products such as CAR-T. Monitors quality assurance activities and compliance with regulatory entities including FACT, CLIA, NMDP, CIBMTR, and FDA. Responsible for qualification, validation, auditing of all critical processes, equipment, supplies, and vendors, and proficiency testing. Facilitates creation and maintenance of critical documents such as SOPs, forms, worksheets, and product labels. Approves technical lab processes and procedures. Manages the cell lab team and team member training and competency. Continuously communicates with the Clinical Program and Cell Processing Lab Medical Directors. Ensures adherence to workflows to ensure preservation of chain of identity and chain of custody, and safety, purity, and viability of all cellular therapy products. Maintains cell storage cataloging, and cell dose and engraftment data. Facilitates expense budgets and authorizes expenditures, and identifies opportunities for controlling costs and for improving operations.

Requirements

• 4 Year / Bachelor's Degree in Medical laboratory science or chemical, physical, or biological science from an accredited university.
• 2-4 years of generalist experience, including Hematology, Coagulation, Urinalysis, Microbiology, and Blood Bank.
• 8 years of relevant laboratory technology and/or leadership experience preferred.
• Experience and training in peripheral blood stem cell transplant, CAR-T therapy, flow cytometry, and cryogenics.
• Laboratory management experience.
• MLS (ASCP or AMT) certification required.

Nice To Haves

• Specialist certification from accrediting agencies (BB, C, CG, CT, H, HTL, M, MB).

Responsibilities

• Deliver the most remarkable patient experience in every dimension, every time.
• Foster teamwork, team member engagement, and community involvement.
• Leverage diversity and inclusion in support of quality care.
• Foster a safe patient environment driven by the principles of 'First Do No Harm'.
• Provide expert guidance to the multidisciplinary team regarding cellular therapy product management.
• Lead Best Practice committees for laboratory services.
• Ensure compliance with regulatory agencies.
• Recommend an appropriate organizational structure and personnel plan for the laboratory.
• Assist with the development of an equipment plan for the laboratory and oversee execution of the plan.
• Ensure that service level standards of the laboratory are met.
• Assist with the preparation of and oversee department budgets.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Hospitals
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees