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Cell Manufacturing Technician

Employer
Astrix Technology Group
Location
Bethesda, MD
Closing date
Aug 20, 2022
*OVERVIEW* (1) manufactures cell and gene therapies for phase I and II clinical trials; (2) processes hematopoietic stem cell grafts for transplantation at the NIH Clinical Center; (3) develops new cell therapies; (4) performs in-process and lot release testing of cell and gene therapies; (5) develops new assays to test cell and gene therapies; and (6) prepares chemistry, manufacturing, and controls (CMC) documents for investigational new drugs (IND) and summary data for annual reports to the Food and Drug Administration (FDA). *ROLES / RESPONSIBILITES* * Build and optimize a robust cGMP compliant platform for generation, expansion and cryopreservation of autologous induced pluripotent stem cells (iPSCs) from peripheral blood derived CD34+ cells. * Differentiate iPSCs to retinal pigment epithelial cells (RPE) to develop an iRPE patch for a phase I clinical trial to treat "dry" age related macular degeneration. * Update and validate SOPs related to CD34 expansion, iPSC culturing, and RPE differentiation * Manage a day to day operation of GMP facility * Maintain iPSC colonies and freeze their early passages. * GMP and aseptic culturing of iPCSs and differentiation of patient iPSCs into Retinal pigment epithelium (RPE) and maintenance of those RPE cultures. This work will include: * Preparing media, supplements, and reagents needed cell culture work. * Maintaining the cell culture room biosafety level 2 standards and maintaining aseptic conditions in cell culture flow hoods, incubators, and prepare sterile tools needed for work with cell cultures. * The cell culture maintenance work will require working for short periods of times on the weekends and some holidays. * Work to characterize the iPSC colonies for their pluripotency. This will require: * Immunostaining of iPSCs, preparing RNA and cDNA from iPSCs, and Performing qRT-PCR assays. * Additionally they will perform three germ layer assay based functional characterization of iPSCs. This work will also include any cell types that act as control for his iPSC work. * Prepare regulatory documents for FDA and technology transfer * Coordinate transfer of lab-technology to Good Manufacturing Practice (GMP suite) * Develop Standard Operating Procedures (SOPs) with the Contract Research Organization (CRO) in relation to the cell therapy project. *DESIRED BACKGROUND* * BS and a minimum of two (2) years of experience in a related field is required, but a MS in cellular engineering or a related discipline and a minimum of one (1) year of relevant experience is preferred * Prior stem cell culture experience is required * Prior experience working in a cGMP environment is required *LOCATION* The world famous Building 10 on NIH's main campus in Bethesda Maryland IND123 Job Type: Full-time Schedule: * 8 hour shift Work Location: One location

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