Cellular Therapy Scientist, Full-Time, Days

7 days ago


Chicago, Illinois, United States Northwestern Memorial Healthcare Full time
Job Summary

We are seeking a highly skilled Cellular Therapy Scientist to join our team at Northwestern Memorial Healthcare. As a key member of our laboratory, you will be responsible for manufacturing cellular therapy products for treatments of patients on clinical trials and standard of care plans.

Key Responsibilities
  • Manufacturing and Quality Control
    • Responsible for manufacturing autologous and allogeneic cell and gene therapy products according to standard operating procedures and specific guidance for clinical trials/commercial products, using aseptic technique.
    • Performs cell and gene therapy product manufacturing under GXP (GLP, GTP, GMP, GDP) guidelines and protocols to ensure the quality of cellular therapy products and regulatory compliance.
    • Performs various quality control testing of cellular therapy products and components with immunological and cell biological techniques required for the quality of cellular therapy products.
  • Process Development and Validation
    • Performs process development, assay development, optimization, validation, and verification for cellular therapy investigational new drug applications.
    • Ability to troubleshoot issues in process and assay development, analyze results and compile reports.
  • Technology Transfer and Maintenance
    • Performs technology transfer from lab bench to clinical manufacturing.
    • Performs preventative maintenance on facility and instruments/equipment in a timely fashion according to defined procedures and schedule.
  • Quality Assurance and Regulatory Compliance
    • Assists in inspections and audits to ensure compliance with regulations from Federal Drug Administration (FDA) and other regulatory agencies.
    • Verifies reagents and supplies meet defined acceptability criteria upon receipt and prior to use; take action to ensure unacceptable items are removed from use.
Requirements
  • Bachelor's degree in Medical Technology, Medical Laboratory Science, Clinical Laboratory Science, Chemistry, Biology, immunology, Molecular Biology and other related field.
  • Minimum of 1~2 years of relevant laboratory experience including training in a technical specialty.
Preferred Qualifications
  • Master's degree or higher in Chemistry, Biology, immunology, Molecular Biology and other related field.
  • Working Experience in a cellular therapy laboratory or in clinical hematology or blood bank setting preferred. Bone marrow and/or stem cell processing, blood banking, hematology, cell culture and apheresis.
  • Experience with processing of either mammalian cells for upstream and downstream processing of viral vectors, or primary tissue and human blood for the isolation and expansion of immune cell populations (e.g. T-cells, NK cells, T-regs, monocytes, dendritic cells, etc.) and also characterization assays for cells and proteins (flow cytometry, ELISA, functional assays, etc.).

Northwestern Memorial Healthcare is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.



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