Cell Manufacturing Technician
- Location: Bethesda, MD
- Type: Direct Hire
- Job #33209
(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.
- B.S. and a minimum of two (2) years of experience in a related field is required, but a M.S. 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
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