Stem Cell therapist with 10 + years experience working at a leading, worldwide, cell therapy company which provides support to the development of commercial products and the manufacture of human progenitor cells for the treatment of cancers. Skills range from processing stem cells for clinical use in a cGMP facility to developing lab processes for clinical trials, coordinating data collection of clinical trials via oncology clinicians, writing and executing lab SOPs, equipment validation protocols, managing entire stem cell patient inventory within cryogenic freezers, performing data management, QA/QC/PM, and negotiating contracts with vendors for equipment and services.
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Assisted Scientific Director in the product and process development of AMR001 pharmaceutical grade cGMP manufactured product that could be distributed commercially.
Assisted Scientific Director in Phase 1 Amorcyte clinical trial which is currently in Phase II
Successfully accounted for and re-assessed patient inventory, over 15,000 patient products and samples
Managed logistics for the movement of cryogenic freezers containing delicate, temperature sensitive, life-saving products and lab equipment for company relocation.
Hired as a per diem to perform various tasks where needs were deficient in the company. Reported statistical product data to Director of Operations, temporarily covered for lab manager while she was away on maternity, assisted scientific director in research lab with pre clinical research and phase I clinical trial, write and execute equipment validation protocols & lab SOPs. Performed all aspects of stem cells processing for patient transplant in clean rooms. Managed a team of 4 to organize, reassess, accurately track patient inventory in cryogenic freezers. Responsible for daily monitoring, PM and service of cryogenic freezers located at Hackensack and Allendale, NJ facilities
autologous and allogeneic stem cells collected world wide for the treatment of cancer under the direction of Dr. Andrew Pecora and Dr. Robert Preti, PhD
Lead tech in pre-clinical/clinical trial studies involving expansion of stem cells and isolation of CD34+ cells
Process/freeze/thaw bone marrow, peripheral blood, cord blood for patient t
Lead technologist in the hospital's stem cell lab.
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