Jobs at Legend Biotech

Manage global biotechnology patent portfolios, including drafting and prosecuting applications, post-grant proceedings, freedom-to-operate and validity analyses, and IP risk mitigation. Advise on licensing, collaborations, acquisitions, business development, diligence, litigation, and commercial agreements. Partner with scientists and business leaders to develop IP strategy across cell, gene, antibody, and process development programs while coordinating outside counsel and global stakeholders.

Manages QC samples and retains, including documentation, shipments, inventory reconciliation, inspections, and consolidation. Performs non-conformance investigations and corrective and preventive action documentation. Reviews QC records and logbooks, uses LIMS and Microsoft Office, supports regulatory and internal audits, and identifies cGMP process gaps. Requires an undergraduate degree in a relevant science, pharmaceutical or biopharmaceutical industry experience, quality systems knowledge, shift flexibility, and occasional travel.

Performs quality control testing for autologous CAR-T products in a controlled cGMP cleanroom environment. Responsibilities include testing raw materials, utilities, in-process samples, and final products; reviewing laboratory data; documenting work in LIMS; preparing QC documents, SOPs, and work instructions; and supporting regulatory compliance. The role requires collaboration with Quality Assurance, Manufacturing, and Analytical Development teams, exposure to biological materials and hazardous chemicals, and flexibility for shifts, overtime, and occasional travel.

Leads QA operations for CAR-T cell therapy manufacturing, ensuring cGMP compliance across product disposition, batch record review, shop-floor oversight, QC laboratory support, and quality systems. Manages senior quality leaders and professionals, develops long-term quality programs, monitors operational metrics, drives continuous improvement, coordinates cross-functional quality activities, and supports regulatory compliance and business process alignment.

Designs, executes, and optimizes upstream lentiviral vector production processes using mammalian cell culture, transient transfection, and bioreactors. Develops scale-up and scale-down models, supports GMP technology transfer and clinical manufacturing, troubleshoots process issues, documents technical findings, and collaborates with downstream, analytical, project management, and CDMO teams. Provides technical guidance to junior staff and contributes to regulatory submissions and continuous process improvement.

Develops and optimizes lentiviral vector downstream purification processes and evaluates innovative manufacturing, analytical, and characterization technologies for cell and gene therapies. Designs and executes feasibility, proof-of-concept, scale-up, and characterization studies; analyzes data and provides technical recommendations. Supports technology integration into development and manufacturing workflows, cross-functional knowledge transfer, protocol and report preparation, and innovation laboratory operations. Independently manages assigned technical activities and project deliverables.

Supports and maintains R&D laboratory applications, including Blue Mountain RAM and LabVantage LIMS/ELN. Configures enhancements, manages master data and user accounts, troubleshoots instrument connectivity and software issues, performs testing and change control, and supports GxP qualification, CSV, inspections, SOPs, training, and IT service management. The role collaborates with laboratory, manufacturing, and IT teams to improve compliance, efficiency, and laboratory testing operations.

Aggregates and verifies process data from MES, SAP, LIMS, Anaplan, eLN, and other systems; develops reports and dashboards; supports investigations, data integrity reviews, trend analyses, regulatory responses, change-control impact assessments, data mapping, and Technical Operations process improvement activities.

Supports daily biotechnology laboratory operations by receiving and tracking samples in LIMS, maintaining equipment and records, managing reagents and supplies, assisting with testing, and ensuring SOP, safety, EHS, regulatory, and audit-readiness compliance. Coordinates sample handling, shipments, inventory, waste management, documentation, and issue escalation with scientists and support teams.

Supervise CAR-T product quality investigations, ensuring timely completion, accurate root-cause analysis, product impact assessment, corrective actions, and effectiveness checks. Train investigators, track deviations and trends, support process improvements and change control, ensure cGMP and regulatory compliance, coordinate audits, maintain production databases, analyze quality data, and review SOP and batch record revisions.

Oversee quality systems for a commercial CAR-T manufacturing site in a sterile GMP environment. Lead quality systems, investigations, CAPA, risk management, compliance, inspection readiness, governance, and continuous improvement teams. Direct complex investigations, root-cause analysis, effectiveness checks, metrics, dashboards, and cross-functional projects. Partner with manufacturing, quality control, engineering, supply chain, and technical operations to mitigate risks, improve compliance, and sustain robust quality processes.

Supports Phase I/II CAR-T oncology clinical trials through trial start-up, execution, and close-out. Maintains regulatory files and Trial Master Files, coordinates sites, vendors, CROs, meetings, and submissions, tracks enrollment and milestones, supports data reconciliation, ensures ICH-GCP compliance, resolves operational issues, and mentors junior Clinical Trial Associates.

Execute manufacturing and support procedures for autologous CAR-T products in a cGMP cleanroom. Responsibilities include cell culturing, purification, aseptic processing, cryopreservation, batch documentation, sampling, equipment operation, material preparation, investigations, audit support, safety compliance, and continuous process improvement. The role requires handling biological materials and hazardous chemicals, following shift schedules, completing training, maintaining cleanroom standards, and collaborating cross-functionally to meet production requirements.

Leads development, optimization, modeling, automation, and scale-up of lentiviral vector downstream purification processes. Applies engineering, machine learning, analytics, and advanced process control to clarification, chromatography, and TFF workflows. Translates bench-scale processes to GMP manufacturing, supports technology transfer and clinical production troubleshooting, authors regulatory and technical documents, and guides scientists. Collaborates across upstream, analytical, technical development, project leadership, and external manufacturing teams to improve vector recovery, purity, potency, and process robustness.

Provides commissioning, qualification, and validation support for a cGMP cell therapy manufacturing plant. Responsibilities include executing CQV protocols, managing projects and vendors, supporting investigations and CAPAs, developing remediation plans, authoring compliance documentation, assessing change controls and risks, presenting audit materials, and training junior staff. The role requires independent decision-making, cross-functional collaboration, and expertise in cGMP, cGTP, cell therapy manufacturing, data integrity, and regulatory requirements.

Owns and optimizes Workday Compensation, Performance Management, and Talent modules. Leads configuration, compensation cycles, talent processes, releases, testing, security, documentation, troubleshooting, controls, and continuous improvements. Partners with Compensation, Talent, HR, and HRIS stakeholders to translate requirements into scalable solutions, prioritize enhancements, support adoption, and maintain system integrity and audit readiness.

Administer U.S. biweekly payroll in Workday for exempt and non-exempt employees, including off-cycle payments, deductions, taxes, equity, benefits, time, and absence transactions. Review payroll calculations, reconcile results, resolve discrepancies, prepare reports, manage employee inquiries, and support payroll audits, SOX controls, tax compliance, and year-end W-2 activities. Partner with HR, Benefits, Compensation, Finance, Legal, and managers while improving payroll processes.

Manages HR policies, risk oversight, compliance, internal controls, SOX controls, audits, and remediation activities. Maintains the HR Risk & Control Matrix, conducts control assessments, monitors risk indicators, supports regulatory reporting, and partners with HR leaders, Legal, Internal Audit, and external auditors. Oversees data privacy and investigation governance while preparing compliance reporting and strengthening the HR control environment.

Execute and optimize lentiviral upstream processes from shake flasks to 40 L bioreactors for in‑vivo CAR‑T programs. Design experiments, perform transient transfection or stable cell line development, optimize media and feeding strategies, ensure scalability and data integrity, collaborate cross-functionally for technology transfer, and prepare technical reports while adhering to BSL‑2 and ELN documentation standards.

Supports production of personalized CAR-T cell therapies in a sterile cGMP environment. Performs cell culture, purification, aseptic processing, and cryopreservation according to procedures and batch records. Records production data, follows safety and quality requirements, collaborates with Manufacturing, Engineering, and Quality, and contributes to process development and continuous improvement. The role requires shift work, handling biological materials and hazardous chemicals, physical dexterity, lifting up to 50 pounds, prolonged standing, and occasional unplanned overtime.