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Job Details |
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Company:
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TalentWRx |
| Job Title: |
Laboratory Director |
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Job Category:
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Biotech/Life Sciences |
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Job Description:
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GENERAL JOB DESCRIPTION
Provide direction and management of the Cell Processing Facility and act as a liaison to the Quality Assurance Department.
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.
Oversee the Flow Cytometry Laboratory which would include all Quality Control, applicable proficiency testing and staff training.
Demonstrate sufficient knowledge to act as a back up for the Laboratory Supervisor (demonstrate knowledge of StemLab System).
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.
Provide training to our affiliates when required.
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.
Consults with other testing laboratories concerning test results.
Responsible for scheduling staff daily as well as long term schedules. Responsible for time management of staff and time cards.
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.
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 & RESPONSIBILITIES
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).
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.
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.
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Skills:
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Employment Type:
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Salary:
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$130 |
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| Other Information |
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Degree:
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Bachelors |
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Experience (years):
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10 |
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Job Location:
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Tampa - Florida - USA |
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Post Date:
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11/02/2009 |
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| Contact Information |
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| You need to login to view Contact Details of this job. |
| Contact Instructions: |
jsieracki@talentwrx.com |
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