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Cell Therapy Specialist

Company: NKMax America, Inc.
Location: Irvine
Posted on: November 11, 2019

Job Description:

Job Summary

  • Perform all the tasks associated with the manufacture of clinical product, strictly adhere to batch records, SOP's and cGMP regulations. Ability to accurately complete documentation associated with clinical manufacturing
  • Responsible for processing patient blood samples and blood base product, prepare cell culture media, processing and expansion of cells in a cGMP manufacturing facility
  • Performs cell manufacturing related activities while wearing clean room attire in an aseptic cGMP manner
    General Accountabilities
    • Work as part of a small team to execute GMP runs in manufacturing
    • Processing patient samples: whole blood and leukapheresis
    • Perform QC testing: FACS, cytotoxicity assay, PCR and endotoxin
    • Routine monitoring of equipment
    • Generates CoAs for product release
    • Perform procedures and maintain accurate documentation in compliance with FDA's Good Laboratory Practices, Good Manufacturing Practices. Recording and maintaining corresponding batch records and log books per established procedures ensuring accuracy and timely completion
    • Maintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cellular products until release
    • Must follow special cleaning and gowning for the facility. Required to work in clean room environment requiring specialized gowning such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers
    • Perform error free calculations of cell concentrations, dilutions, viabilities during production
    • Must maintain and apply knowledge regarding patient information, screening and testing, labeling and product acceptability and release criteria
    • Be flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with highest quality
    • Handles human blood and human blood base product
    • Maintains current inventory of supplies
    • Other duties as assigned
      Job Qualifications
      • Education: requires bachelor's degree or 3 or more years of cGMP experience in a manufacturing pharmaceutical/biotechnology environment
      • Detail oriented, a must
      • If required, able to work on weekend, off-shift and long hours
      • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
      • Cell culture processing experience in handling and propagation of human primary cell, K562
      • Previous experience with cell therapy products is a plus
      • Strict adherence to SOP's and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing
      • Self-motivated and willing to accept responsibilities outside of initial job description
      • Ability to lift over 30lbs.
        --- Skills
        • Excellent skill in Microsoft word, Excel and data analysis
        • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

Keywords: NKMax America, Inc., Irvine , Cell Therapy Specialist, Healthcare , Irvine, California

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