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    Duties

    Summary

    The ideal candidate will possess the following: Knowledge of medical technology applicable to the manufacture of cellular therapy products within a cleanroom environment and complex problems involving diverse aspects of clinical laboratory practice related to cellular therapy products such as difficulties with cell counting, viability testing and flow cytometric assays.

    Applicant should have experience with aseptic processing performed in a biologic safety cabinet.

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    Responsibilities

    If selected for this position, your responsibilities will include the following:
    Performs manufacturing of cellular therapy products for clinical and research protocols as assigned on a daily basis.
    Serve as the point person for dissemination of information pertaining to the assigned product or duty to coworkers, physicians, patient care team, biomedical engineers and other health care professionals.
    Organize records forms and labels necessary for HCT/P manufacture.
    Perform required quality control steps as outlined in SOPs.
    Perform trouble shooting during HCT/P manufacturing and assay performance, documents actions required to resolve problem and initiates corrective action as needed
    Perform data retrieval and entry as required using multiple IT systems.
    Maintain working knowledge of regulatory requirements as defined by current version of CPS Drug Master File, applicable sections of FDA Code of Federal Regulations and current edition of AABB Standards for Cellular Therapy Product Services.

    Travel Required

    Not required

    Supervisory status

    No

    Promotion Potential

    11

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/515483900. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.