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Microbiologist / Environmental Monitor

Edison-New Brunswick Metro Area, New Jersey

Post Date: 01/06/2017 Job ID: JN -012017-18059
  • The primary responsibility of this position is the performance of Environmental Monitoring (EM) tasks along with associated bio-analytical testing and reporting for the clinical production of cell therapy products.
  • B.S. degree in Biochemistry, Microbiology, Biology or related discipline
    Cell culture experience
    Experience with environmental monitoring and aseptic processing required
    2+ years of device, biologics or HCT/P industrial experience
    Proficient in Microsoft Word/Excel/Accessend analysis and lot release reporting of EM data.
    Analytical testing of cellular therapy products: Perform in-process and final product analysis of clinical release which includes cell counts, endotoxin testing, sterility testing, send outs, and other tests as needed.
    Assist in analytical trouble shooting and investigations as needed.
    Update and maintain analytical data in DQC database.
    Perform raw materials inspection and approval, including placental raw material.
    Perform routine control and calibration of DQC instruments and equipment.
    Participate in investigations as needed.
    Monitor DQC inventory of reagents and supplies. Re-order as needed.
  • Environmental Monitoring of cellular therapy production areas:
    -- Coordinate with Clinical Production staff for daily EM test schedule and activities.
    -- Collection of EM samples (air, surface and personnel) from controlled laboratory areas.
    Aseptic gowning required for entry into controlled areas.
    Processing, incubation and evaluation of environmental test samples and incubation chambers.

    Organization and completion of EM documentation and entering of data into the EM database.
    Perform trend analysis and lot release reporting of EM data.
    Analytical testing of cellular therapy products: Perform in-process and final product analysis of clinical release which includes cell counts, endotoxin testing, sterility testing, send outs, and other tests as needed.

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