Job Application for Manager CAR-T Laboratory Services at West Cancer Center

Summary:

Responsible for the overall functioning and management operations of the CAR-T cell therapy laboratory. Collaborates with the clinical team and the CAR-T production labs to manage/assure operational effectiveness, quality assurance requirements, and programmatic needs. Performs multiple administrative functions in support of laboratory operations and serves as a technical expert in a laboratory specialty area. Follows established procedures to ensure laboratory quality control and compliance with professional standards of practice. Responsible for CLIA and any other certification requirements of the lab. Supervisory staffing responsibilities as needed. Models appropriate behavior as exemplified in West Cancer Centers Vision and Values.

Education/Training & Experience:

	Education/Formal Training	Work Experience	Credential/Licensure
REQUIRED:	Master’s degree in clinical laboratory science or a related field with significant experience in cell therapy processing.	Minimum of eight (8) years’ laboratory experience. Five (5) years’ experience in cell processing required. Experience with method validation and quality assurance.	Must be currently licensed in the State of Tennessee as a Clinical Laboratory Scientist or Medical Technologist. Certification or licensure as a specialist in certain laboratory areas.
PREFERRED:	N/A	Previous experience managing a clinical laboratory Experience in lab certification processes
SUBSTITUTIONS ALLOWED:	N/A	N/A	N/A

Knowledge/Skills/Abilities:

Thorough knowledge of clinical laboratory procedures, practices, and regulatory standards.
Thorough knowledge of laboratory safety and infection control procedures and practices including handling of hazardous chemicals.
Ability to apply critical thinking and problem-solving skills.
Understands and interprets complex written materials and technical reports.
Effective communicate skills to work with all levels of Associates, management, physicians, and patients and their families.
Demonstrated ability to lead and motivate individuals and groups toward the accomplishment of organizational goals.
Demonstrated ability to work independently and to consistently exercise sound judgment and initiative in a wide range of circumstances.
An effective planner with strong skills in scheduling and organizing workflows.

Key Job Responsibilities:

Responsible for performing technical processing procedures and associated quality functions related to Car-T cellular therapy products.
Responsible for laboratory operations with strict adherence to applicable regulations and standards.
Authors/adheres to established SOPs, policies and procedures including Good Manufacturing Practices, and other regulatory requirements.
Collaborate with clinical team to coordinate patient sample collection, processing, freezing and shipping to manufacturing lab, as well as receipt and storage of CAR-T cell products upon receipt from Car-T processing lab.
Communicate effectively with clinicians regarding patient status and potential challenges.
Perform and analyze data from flow cytometry. Assist with collection and processing of specimens as needed including bone marrow collection. Performs and remains competent for other clinical laboratory sample analysis
Meets and maintains all requirements for laboratory certification including CLIA and Car-T specific certification.
Monitors productivity, budgets, and expenditures for assigned laboratory area.
Implements and monitors quality control programs to ensure reliability of testing products, proper function of laboratory equipment including equipment service contracts, and compliance with federal and regulatory standards. Prepares and maintains records and documentation.
Provides advanced problem solving, critical thinking and troubleshooting, technical assistance, and instruction in assigned area. Trains other lab personnel as needed.
Responsible for compliance with regulatory requirements, inspection readiness, and procedure manual oversight.

Supervision Provided by this Position:

Supervises support personnel in assigned area as needed.

Physical Demands/Conditions:

The physical activities of this position may include climbing, pushing, standing, hearing, walking, reaching, grasping, kneeling, stooping, and repetitive motion.
Must have good balance and coordination.
The physical requirements of this position are: light work - exerting up to 25 lbs. of force occasionally and/or up to 10 lbs. of force frequently.
The Associate is required to have close visual acuity to perform an activity, such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; or extensive reading.
The conditions to which the Associate will be subject in this position: The Associate is not substantially exposed to adverse environmental conditions; job functions are typically performed under conditions such as those found in general office or administrative work.

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Manager CAR-T Laboratory Services

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