Wen Zhe Xian

Senior Process Development Associate at Artiva Biotherapeutics
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Contact Information
us****@****om
(386) 825-5501
Location
San Diego, California, United States, US

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Experience

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Senior Process Development Associate
      • Jun 2022 - Present

      San Diego, California, United States

    • Process Development Associate III
      • Jul 2021 - Present

      San Diego, California, United States

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Cell Therapy Specialist II
      • Oct 2016 - Jun 2021

      Santa Monica, California • Assist in development of standard operating procedures, batch records. • Participate in process and MES improvement. • Troubleshooting processing and equipment (Sepax, CliniMacs) issues. • Attend train the trainer programs to deepen professional skillset and assist in training co-worker and new hires. • Attend technical writing classes and qualified for deviation investigation, writing and reporting. • Perform all tasks associated with manufacture of clinical and commercial… Show more • Assist in development of standard operating procedures, batch records. • Participate in process and MES improvement. • Troubleshooting processing and equipment (Sepax, CliniMacs) issues. • Attend train the trainer programs to deepen professional skillset and assist in training co-worker and new hires. • Attend technical writing classes and qualified for deviation investigation, writing and reporting. • Perform all tasks associated with manufacture of clinical and commercial products following batch records and SOPs. • Use aseptic technique in ISO5 BSC. Show less

    • United States
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • Manufacturing Associate
      • Jun 2015 - Oct 2016

      Tustin, California • Daily production scheduling and end of the shift reporting. • Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms. Perform Design of Experiments. • Participate in cross functional meetings with process development and performing engineering runs. • Apply fundamental scientific and engineering principles to resolve issues and evaluate effects of process. • Data analysis for engineering run. • Deviation investigation and reporting,… Show more • Daily production scheduling and end of the shift reporting. • Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms. Perform Design of Experiments. • Participate in cross functional meetings with process development and performing engineering runs. • Apply fundamental scientific and engineering principles to resolve issues and evaluate effects of process. • Data analysis for engineering run. • Deviation investigation and reporting, change control and CAPA. • Equipment and process validation. • Cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 36L spinner flasks performed in a Biological Safety Cabinet) • Operate and maintain cell culture bioreactors (100L – 1000L stainless steel and disposable Sartorius, 25L to 50L GE Wave) in batch, fed-batch, and perfusion modes. • Harvest operations – pod filtration and TFF system. • Media mixing, filtration, fill, freeze and thaw operation. • Perform equipment cleaning, sterilization and pressure test. Show less

    • Internet sales manager
      • Oct 2009 - May 2015

      Greater Los Angeles Area • Product presentation • Negotiation • Interpersonal communication

Education

  • University of California, Riverside
    Bachelor's Degree, Biology, General
    2009 - 2014

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