Contractor - Patient Cell Operations

Iconma LLC

  • WA
  • 12 days ago
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    Skills

    • Apheresisunmatched
    • Business Administrationunmatched
    • Cell Biologyunmatched
    • Clinical Supportunmatched
    • Clinical Trialunmatched
    • Continuous Improvementunmatched
    • Cross-Functionalunmatched
    • Document Managementunmatched
    • Drug Productsunmatched
    • GxPunmatched
    • Health Planunmatched
    • Healthcare Qualityunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Operationsunmatched
    • Onboardingunmatched
    • Operations Managementunmatched
    • Operations Processesunmatched
    • Patient Careunmatched
    • Process Improvementunmatched
    • Program Controlunmatched
    • Regulatory Complianceunmatched
    • Supply Chain Operationsunmatched
    • Training Programunmatched

    Description

    Our Client, a Clinical-Stage Cell Therapy company, is looking for a Contractor - Patient Cell Operations for their Remote location.

    Responsibilities:

    • This role is responsible for the day-to-day operational management of patient cells across the cell therapy lifecycle, including apheresis, tissue collection, and final drug product handling.
    • The position partners closely with Manufacturing, Clinical Operations, Quality, clinical sites, and external vendors to ensure right-first-time execution of patient cell handling processes supporting clinical trials and manufacturing activities.
    • Manage patient cell operations activities including apheresis and final drug product handling.
    • Create and maintain controlled documentation and operational manuals.
    • Manage CAPAs, deviations, and process improvements.
    • Coordinate with clinical sites, apheresis centers, and external suppliers.
    • Lead site readiness, onboarding, and training initiatives.
    • Ensure compliance with GxP requirements and operational procedures.
    • Support continuous improvement of Patient Cell Operations processes and tools.

    Requirements:

    • BA/BS with 10+ years of relevant experience, or MBA/MS with 7+ years of experience.
    • Minimum 5 years of patient cell operations management experience.
    • Experience in cell therapy, biologics, clinical operations, or supply chain within a GxP-regulated environment.
    • Strong experience with CAPAs, deviations, training programs, and controlled documentation.
    • Experience working cross-functionally with Manufacturing, Quality, Clinical Operations, and external partners.

    Why Should You Apply?

    • Health Benefits
    • Referral Program
    • Excellent growth and advancement opportunities

    Numbers & Facts

    LocationWA

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