Manufactures cell and gene therapies for phase I and II clinical trials; (2) processes hematopoietic stem cell grafts for transplantation ; (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 experience in a related field is required,

Prior cell culture experience is required

LOCATION

The world famous Building 10 on NIH’s main campus in Bethesda Maryland

IND123

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Bethesda, MD 20892: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• What salary range are you seeking?

Work Location: One location

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