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Laboratory Director / Manager
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Full-time
- Degree Qualifications: One of the following:M.D Ph. D. in the life sciencesM.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.
- Reports to:CEO Medical DirectorDuties and Responsibilities: Responsible for all technical operations of the LaboratoryMust be accessible 7 days a week either on-site or by phone to address any laboratory issuesHas knowledge of cGTP and cGMP manufacturingIs very knowledgeable with respect to cellular therapy and regenerative medicineProcesses samples as neededMaintain 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.
- Reviews and approves and signs off on all Quality Control activities in the Laboratory.
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