celebration stem cell centre
Laboratory Director / Manager
celebration stem cell centre, Gilbert, Arizona, United States, 85233
Degree Qualifications: One of the following
M.D
Ph.D. in the life sciences
M.D., Ph.D.
Job Description The laboratory director will oversee all technical aspects of the laboratory which include all technical steps in the processing and cryopreservation of cell therapy products from various tissue sources.
Oversees all the day‑to‑day operations involved with the collection, processing , cryopreservation, storage and release of high quality cellular therapy products including umbilical cord blood, adipose tissue, adipose tissue stem cells, dental pulp stem cells and other cell therapy products and must ensure that these activities are compliant with the FDA, AABB, NMDP, HIPAA and other regulatory bodies.
Develop new processes and procedures when necessary.
Must have excellent critical thinking skills to be able to troubleshoot any issue with the processes and instrumentation.
Reports to : CEO
Medical Director
Duties and Responsibilities
Responsible for all technical operations of the Laboratory
Must be accessible 7 days a week either on‑site or by phone to address any laboratory issues
Has knowledge of cGTP and cGMP manufacturing
Is very knowledgeable with respect to cellular therapy and regenerative medicine
Processes samples as needed
Maintain current knowledge of the science surrounding these products, cellular therapy, and the regulatory environment.
Ensure compliance with all regulatory agencies including but not limited to FDA, AABB and the NMDP.
Must ensure that the cellular therapy lab activities do not have the potential to adversely affect the safety, potency or purity of the product ensures donor and recipient safety and lab staff safety.
Trains all new technical staff
Selects and validates any new equipment for the Laboratory
Continuing education in all areas related to the cellular therapy products generated in the facility.
Ensures the facility is as technologically advanced as financially possible
Reviews and approves and signs off on all technical processes and procedures in the laboratory.
Reviews and approves and signs off on all Quality Control activities in the Laboratory.
Document the review of all cell therapy products, equipment, consumables and testing.
Approves all purchasing for the laboratory
Orders all laboratory supplies and ensures that there is at least a month worth of lab supplies on-hand
Determines donor eligibility
Determines if the cellular therapy products meet acceptance criteria
Releases cellular therapy products from quarantine
Works closely with the Quality Department to ensure regulatory compliance
Investigates all adverse events, errors and complaints and documents this investigation and determine the root cause.
Periodically audits the staff during process to ensure compliance with SOPs.
Designs validation experiments as necessary to validate new processes or procedures or changes to current processes and procedures.
Analyzes proficiency testing data
Reviews all SOPs and quality documents on an annual basis
Approves any changes to the technical SOPs
Communicates regularly with the Medical Director, notifying him of any problems or concerns
Reviews contracts for new laboratory services
Responsible for ensuring that all preventative maintenance is performed on all the equipment at the scheduled times
Manage the technical staff.
Provides technical guidance to the facility with respect to any technical questions or new services
Must be articulate and be able to communicate both orally and in written documents
Must be able to understand complex documentation.
Must have training relevant to cell therapy, stem cells, cell culture, flow cytometry and cryogenics
Provides scientific consulting services to CSCC customers, clients and patients
Responds to any facility alarms 24 hours a day
Other duties as assigned
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Ph.D. in the life sciences
M.D., Ph.D.
Job Description The laboratory director will oversee all technical aspects of the laboratory which include all technical steps in the processing and cryopreservation of cell therapy products from various tissue sources.
Oversees all the day‑to‑day operations involved with the collection, processing , cryopreservation, storage and release of high quality cellular therapy products including umbilical cord blood, adipose tissue, adipose tissue stem cells, dental pulp stem cells and other cell therapy products and must ensure that these activities are compliant with the FDA, AABB, NMDP, HIPAA and other regulatory bodies.
Develop new processes and procedures when necessary.
Must have excellent critical thinking skills to be able to troubleshoot any issue with the processes and instrumentation.
Reports to : CEO
Medical Director
Duties and Responsibilities
Responsible for all technical operations of the Laboratory
Must be accessible 7 days a week either on‑site or by phone to address any laboratory issues
Has knowledge of cGTP and cGMP manufacturing
Is very knowledgeable with respect to cellular therapy and regenerative medicine
Processes samples as needed
Maintain current knowledge of the science surrounding these products, cellular therapy, and the regulatory environment.
Ensure compliance with all regulatory agencies including but not limited to FDA, AABB and the NMDP.
Must ensure that the cellular therapy lab activities do not have the potential to adversely affect the safety, potency or purity of the product ensures donor and recipient safety and lab staff safety.
Trains all new technical staff
Selects and validates any new equipment for the Laboratory
Continuing education in all areas related to the cellular therapy products generated in the facility.
Ensures the facility is as technologically advanced as financially possible
Reviews and approves and signs off on all technical processes and procedures in the laboratory.
Reviews and approves and signs off on all Quality Control activities in the Laboratory.
Document the review of all cell therapy products, equipment, consumables and testing.
Approves all purchasing for the laboratory
Orders all laboratory supplies and ensures that there is at least a month worth of lab supplies on-hand
Determines donor eligibility
Determines if the cellular therapy products meet acceptance criteria
Releases cellular therapy products from quarantine
Works closely with the Quality Department to ensure regulatory compliance
Investigates all adverse events, errors and complaints and documents this investigation and determine the root cause.
Periodically audits the staff during process to ensure compliance with SOPs.
Designs validation experiments as necessary to validate new processes or procedures or changes to current processes and procedures.
Analyzes proficiency testing data
Reviews all SOPs and quality documents on an annual basis
Approves any changes to the technical SOPs
Communicates regularly with the Medical Director, notifying him of any problems or concerns
Reviews contracts for new laboratory services
Responsible for ensuring that all preventative maintenance is performed on all the equipment at the scheduled times
Manage the technical staff.
Provides technical guidance to the facility with respect to any technical questions or new services
Must be articulate and be able to communicate both orally and in written documents
Must be able to understand complex documentation.
Must have training relevant to cell therapy, stem cells, cell culture, flow cytometry and cryogenics
Provides scientific consulting services to CSCC customers, clients and patients
Responds to any facility alarms 24 hours a day
Other duties as assigned
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