Lab Manager, Bioassay

Legend Biotech is seeking an Lab Manager, Bioassay as part of the Bioanalytical Sciences team based in Somerset, NJ. 

Role Overview

We are seeking an organized and proactive Lab Manager to oversee day-to-day operations in our lab, which conducts both clinical exploratory biomarker analysis and nonclinical IND-enabling studies. This role is responsible for ensuring operational continuity, regulatory compliance, and optimal efficiency within lab workflows. The Lab Manager will manage a variety of tasks, including audit readiness, equipment maintenance, sample management, and personnel onboarding. This role requires strong knowledge in immunology, oncology, and cell therapy research, with hands-on experience in bioassays across various platforms, including flow cytometry, immunoassays, and molecular testing. The ideal candidate will possess a robust understanding of preclinical development processes and have experience handling and analyzing patient sample matrices.

Key Responsibilities  

• Operational Management & Compliance
  
  • Maintain an audit-ready lab environment, adhering to all relevant regulatory requirements.
    
  • Implement and enforce safety protocols, including chemical and biohazard waste management, to uphold EHS standards.
    
  • Oversee lab cleanliness, organization, and biohazard management, ensuring compliance with safety and EHS guidelines.
    
  • Lead internal audits, ensuring timely response and corrective action as needed.
• Equipment & Resource Management
  
  • Ensure all laboratory equipment, software, and IT systems (including LIMS and network setups) are properly maintained, functional, and compliant with operational needs.
    
  • Oversee data transfer, storage, and regular instrument operation logging to maintain data integrity and regulatory compliance.
    
  • Oversee the maintenance and troubleshooting of Bioanalytical/Biomarker equipment and reagents, including coordinating with IT on instrument and printer setup issues.
• Sample & Inventory Management
  
  • Support sample operations, including ordering of lab supplies (labels, binders, etc.) and weekend coverage as needed.
  • Train on Lab Vantage LIMS and support Biosample Management in patient sample management and testing setup, maintaining detailed records in the LIMS for all samples.
    
  • Work closely with the warehouse for Legend Shipments and any incoming/outgoing samples, ensuring accurate documentation and inventory management.
    
  • Maintain an organized inventory of lab supplies, reagents, and chemicals; forecast supply needs based on usage patterns to ensure uninterrupted operation.
    
  • Ensure accurate and efficient sample processing, particularly with bioanalytical, translational, and preclinical samples.
• Vendor & Budget Coordination
  
  • Collaborate with Procurement, Finance, and Accounts Payable to manage invoices and transactions for preclinical and clinical vendors, BA/TR equipment, and reagents.
    
  • Work with internal stakeholders in vendor management, including procurement, performance monitoring, and invoice review to ensure effective cost management and timely supply.
    
  • Manage contracts and work closely with external suppliers to maintain a seamless supply chain for lab essentials.
• Training, Onboarding & Staff Management
  
  • Train and qualify analysts in bioassays, immunoassays, and patient sample analysis.
    
  • Provide onboarding and skill development in immunology, oncology, and cell therapy research methods.
    
  • Maintain a high level of data quality and ensure all personnel adhere to SOPs and regulatory standards.
• Documentation & Record-Keeping
  
  • Maintain detailed and up-to-date records, including laboratory notebooks, instrument operation logs, maintenance records, error logs, and ELN (Electronic Laboratory Notebook) documentation.
    
  • Ensure proper documentation and version control for SOPs, protocols, and amendments; oversee the timely review and development of new SOPs as needed.
  • Conduct regular reviews of lab records and data, ensuring accuracy, completeness, and adherence to regulatory requirements.

Requirements

• Bachelor’s or Master’s degree in Immunology, Oncology, or related field; Ph.D. preferred.
  
• At least 5 years of laboratory experience, including management, with strong immunology, oncology, and cell therapy focus.
  
• Hands-on experience with bioassays, flow cytometry, immunoassays, and molecular testing platforms.
  
• In-depth understanding of preclinical development and patient sample analysis.
  
• Good understanding of regulatory standards (FDA, GLP, CLIA) and experience in audit preparation and management.
  
• Familiarity with LIMS systems (e.g., Lab Vantage), IT network setup, and database management.
  
• Proven experience in inventory, equipment, and vendor management.
• Strong technical skills in bioassays, flow cytometry, and molecular testing.
  
• Exceptional organizational and multitasking skills.
  
• Strong leadership skills, with experience in staff training and development.
  
• Excellent data management and record-keeping abilities.
  
• Ability to work cross-functionally with departments such as IT, Finance, and Procurement.

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