Responsible for the direction and management of the Cell Processing Facility/Laboratory Operations.
COMPANY POSITION TITLE: Laboratory DirectorREPORTS TO: Vice President of Laboratory Operations and Research & DevelopmentI. GENERAL JOB DESCRIPTION1.Provide direction and management of the Cell Processing Facility and act as a liaison to the Quality Assurance Department.2.Be responsible for supervision and performance of clinical processing of cord blood products and other human cells processed in the facility. Demonstrate competency of processing all cell types manufactured in the facility.3.Oversee the Flow Cytometry Laboratory which would include all Quality Control, applicable proficiency testing and staff training. 4.Demonstrate sufficient knowledge to act as a back up for the Laboratory Supervisor (demonstrate knowledge of StemLab System).5.Manage and direct all processes supported by Standard Operating Procedures for Training and Education, Competency Evaluation, Proficiency Testing, Performance of Validations, Deviations Reports, Customer Complaints, Equipment Qualifications, Records Management, Product Release Procedures and Labeling Control.6.Provide training to our Cryo-Cell affiliates when required.7.Train laboratory staff in all processes. Performs laboratory tasks and is determined to be competent (processing and determinations of cord blood and endometrial menstrual stem cells). Troubleshoots laboratory processes and testing.8.Consults with other testing laboratories concerning test results (e.g. BayCare and FBS).9.Responsible for scheduling staff daily as well as long term schedules. Responsible for time management of staff and time cards.10.Responsible for daily, monthly and annual reviews of all laboratory work including but not limited to instrument QC (Sysmex, Galileo, CRF, Microbiology, and Infectious Disease Markers) and environmental monitoring.11.Direct and review all Competency assessments of staff.II. JOB REQUIREMENTS/QUALIFICATIONS-BS in Medical Laboratory Science, Biology, Biochemistry or related field and Masters Degree or higher in Science. -Minimum 10 years of general laboratory experience, 3 years of management experience and 2 years of experience in cell separation and or processing in a clinical arena.-Licensure as a clinical laboratory scientist or a medical technologist to supervise the laboratory testing.-Demonstrated capacity to effectively lead others.-Fluent (oral/written) English.-Demonstrate computer literacy.-Knowledge in the area of regulatory affairs to the extent that they are able to incorporate regulatory agency requirements (FDA, OSHA, CLIA and guidelines of FAHCT and AABB) into the manufacturing process design. -Knowledge and capable of developing written Standard Operating Procedures (SOPs) for test methods, policies and procedures in this area.-Knowledge and capable of developing written Laboratory Studies and Validations in this area.-Broad professional knowledge of the principles, theories, concepts and methods in the field of medical technology, blood banking, immunohematology, immunology, chemistry, microbiology and cryopreservation.III. BASIC DUTIES & RESPONSIBILITIES1.Responsible for the direction and management of the Cell Processing Facility/Laboratory Operations. This includes employee performance evaluation and employee development. Develop and keep current job descriptions for all reporting personnel in the Facility. Ensure that adequate staffing is available for cell processing and also for research. Manage the overall clinical processing and manufacture of human cells (includes isolation, quantification, processing, viability assessment, and cryopreservation).2.Ensure records for each product (lot) released are reviewed for accuracy, completeness, and compliance with established standards and that discrepancies and lot failures are thoroughly investigated.3.Responsible for day to day management of cell processing and testing and Flow Cytometry. Responsible for management and evaluation of technical staff and performs testing and functions as designated by the VP of Laboratory Operations/R&D.a.Proficiency Testing review, evaluate and monitor the proficiency testing program to ensure the adequate evaluation of test methods, equipment and personnel.b.Validation ensure that adequate validation procedures have been performed.c.Deviation Reports, Complaints, and Adverse Reactions ensure they are done and completed in a timely fashion with the Laboratory Compliance Coordinator as the lead.d.Equipment Validation ensure that procedures are in place for equipment qualification, process validation and revalidation after repairs and records are kept and reviewed of these processes.e.Records Management approve or ensure approval of all record-keeping systems (manual and electronic), validate these and ensure that required records are reviewed for accurate and complete histories of manufacturing process.f.Product Release Procedures ensure that records for each product (lot) released are reviewed for accuracy, completeness, and compliance with established standards and that discrepancies and lot failures are thoroughly investigated.g.Labeling Control ensure that process controls exist for correct labeling and that the product label is reviewed prior to release.Characteristic Tasks and their Frequencies:80% - Direct and manage the cell processing facility and staff in the areas of Standard Operating Procedures, Training and Education, Competency Evaluation, Proficiency Testing, Validations, Deviations, Customer Complaints, Equipment Validations, Records Management, Lot Release Procedures and Labeling Control.15% - Manage Clinical Flow Cytometry Laboratory and related functions.Responsible for oversight and performance of clinical processing of human cells (including cord blood and menstrual cells) and all related functions.5% - Provide training to affiliates of Cryo-Cell International, Inc.IV. PHYSICAL REQUIREMENTSRandom drug screens are required.Physical (minimum requirements): Stand for 1 hour; sit for 7 hours; perform repetitive tasks/motions; have manual dexterity; push/pull 50 pounds; lift/carry 20 pounds; lift from floor level up; lift from waist level up; lift from shoulder/head.Hearing/Visual: Hear normal speaking voices, telephones and alarms. Have clarity of vision and be able to distinguish colors.Mental/Emotional: Manage stress appropriately; make decisions under pressure; manage fear, anger, and hostility of others appropriately; manage multiple priorities; work alone or independently; work in confined and/or crowded areas.Hazards: Exposure to toxic/caustic chemicals, dust, fumes, gases, communicable diseases, blood and body fluids and/or potential electrical shock. Repetitive motion and/or sedentary ergonomic issues.V. REQUIRED PERSONAL PROTECTIVE EQUIPMENTMaintains universal precautions in handling human blood tissues. Personal Protective Equipment would be determined according to the procedure which may range from a lab coat and gloves to a full sterile garment for the Class 10,000 cleanroom procedures.