732-661-0400

Cell Manufacturing Technician

  • Location: Bethesda, MD
  • Type: Direct Hire
  • Job #33209

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

  • 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

 

LOCATION

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

IND123
 

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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