Cell Manufacturing Technician
OVERVIEWManufactures 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 / RESPONSIBILITESBuild 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 differentiationManage a day to day operation of GMP facilityMaintain 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 transferCoordinate 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 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 preferredPrior cell culture experience is requiredLOCATIONThe world famous Building 10 on NIHs main campus in Bethesda MarylandIND123Job Type:
Full-timePay:
$54,455.
00 - $64,070.
00 per year
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insuranceSchedule:
8 hour shiftAbility to commute/relocate:
Bethesda, MD:
Reliably commute or planning to relocate before starting work (Required)Work Location:
One location.
Estimated Salary: $20 to $28 per hour based on qualifications.
ROLES / RESPONSIBILITESBuild 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 differentiationManage a day to day operation of GMP facilityMaintain 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 transferCoordinate 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 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 preferredPrior cell culture experience is requiredLOCATIONThe world famous Building 10 on NIHs main campus in Bethesda MarylandIND123Job Type:
Full-timePay:
$54,455.
00 - $64,070.
00 per year
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insuranceSchedule:
8 hour shiftAbility to commute/relocate:
Bethesda, MD:
Reliably commute or planning to relocate before starting work (Required)Work Location:
One location.
Estimated Salary: $20 to $28 per hour based on qualifications.
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