Cell Culture Scientist

OVERVIEW

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.

DESIRED BACKGROUND

· Prior cell culture experience is required

· Prior experience working in a cGMP environment is required