Jobs at Legend Biotech

Supports sourcing and procurement activities for U.S. business units, including supplier selection, market analysis, purchasing requisitions and orders, supplier onboarding, SAP master-data maintenance, commercial review, contract workflow, compliance monitoring, spend analysis, reporting, and issue resolution. The role collaborates with Finance, Accounts Payable, suppliers, Legal, and business stakeholders to ensure compliant purchasing, cost management, supplier performance, audit readiness, and supply assurance.

Develop, qualify, validate, and support immunogenicity and biomarker assays for preclinical and clinical cell and gene therapy studies. Responsibilities include ELISA, MSD, and Luminex assay development; troubleshooting; sample analysis; data interpretation; regulatory documentation; LIMS and ELN use; GxP/GLP compliance; method transfer; and cross-functional collaboration.

Leads the global Manufacturing Science & Technology organization and strategy across biopharmaceutical manufacturing. Owns process characterization, validation, technology transfer, continued process verification, lifecycle management, manufacturing optimization, and technical investigations. Provides enterprise leadership across internal sites, CMOs, and CDMOs while advancing automation, digital manufacturing, analytics, and data-driven process improvement. Partners with R&D, CMC, Quality, Regulatory, Engineering, Manufacturing, and Supply Chain to ensure scalable, robust, compliant, and reliable commercial production.

Leads global supply chain, procurement, strategic sourcing, demand and supply planning, inventory, logistics, distribution, supplier management, and supply resilience for commercial biopharmaceutical products. Establishes enterprise strategy, supports launches and lifecycle changes, optimizes cost and working capital, drives digital transformation, and leads a global organization. Partners with manufacturing, quality, CMC, MSAT, commercial, finance, and external suppliers to ensure reliable, compliant patient supply.

Supervises commissioning, qualification, and validation activities for a cGMP cell therapy manufacturing plant. Manages CQV projects, protocols, reports, deviations, CAPAs, remediation, change controls, SOPs, risk assessments, and vendor coordination. Supports audits and regulatory presentations, makes technical and corrective-action decisions, and trains junior staff. Ensures facility, equipment, systems, and processes comply with cGMP, cGTP, data integrity, and applicable FDA, EU, and ICH requirements.

Conducts molecular biology experiments supporting clinical, translational, and preclinical cell and gene therapy programs. Develops, executes, optimizes, qualifies, and troubleshoots qPCR, ddPCR, and NGS assays. Performs nucleic acid extraction, biological sample processing, sequencing library preparation, data analysis, documentation, and instrument maintenance. Manages samples through LIMS and ELN systems while supporting laboratory operations, quality, safety, and workflow improvement.

Perform cell therapy manufacturing operations including cell culture, purification, aseptic processing, and cryopreservation in a sterile cGMP environment. Record production data, follow batch records and SOPs, collaborate with Manufacturing, Engineering, and Quality teams, and support process development and continuous improvement. The role requires handling biological materials and hazardous chemicals, working shifts, standing for extended periods, lifting up to 50 pounds, and accommodating overtime.

Performs quality control testing for autologous CAR-T cell therapy products in a controlled cGMP cleanroom environment. Responsibilities include testing raw materials, in-process samples, and final products; reviewing laboratory data; documenting work in LIMS; preparing and approving QC documents; and following GMP, safety, and quality requirements. The role requires collaboration with Quality Assurance, Manufacturing, and Analytical Development teams, regulatory inspector interaction, biological material handling, shift flexibility, overtime, and occasional travel.

Supports and conducts GxP audits across GCP, GLP, and GVP; coordinates regulatory inspection readiness; manages audit observations, CAPA follow-up, quality documentation, vendor oversight, deviations, investigations, metrics, and data integrity reviews. Advises clinical and preclinical stakeholders, develops SOPs, delivers training, and supports continuous quality improvement. The role is remote with up to 25% domestic and international travel.

Performs manufacturing and manufacturing-support activities for autologous CAR-T products in a cGMP cleanroom. Executes cell culture, purification, aseptic processing, cryopreservation, testing, sampling, documentation, and batch-record tasks. Maintains quality, safety, compliance, material availability, and production schedules while handling biological materials and hazardous chemicals. Supports process development, continuous improvement, investigations, audits, and cross-functional teamwork.

Leads moderate- to high-complexity quality investigations across manufacturing, facilities, engineering, equipment, and validation systems. Responsibilities include data and record review, risk and product-impact assessments, root cause analysis, CAPA development, effectiveness checks, inspection-ready reporting, audit and regulatory inspection support, trend analysis, and cross-functional collaboration. The role also mentors junior investigators and manages investigations through electronic quality management systems.

Manage global clinical supply operations for early-phase cell and gene therapy studies. Responsibilities include demand forecasting, inventory management, packaging and labeling, QA/QP release, distribution, temperature-excursion handling, returns, reconciliation, destruction, vendor oversight, documentation, inspection readiness, and risk mitigation. The role coordinates with clinical sites, depots, CROs, logistics providers, Quality, Regulatory, CMC, and Technical Development teams while independently managing studies and improving compliant supply processes.

Supports development and routine operation of CAR-T manufacturing processes as a technical subject matter expert. Provides frontline troubleshooting, investigates process issues, supports CAPAs and inspections, coordinates with equipment suppliers, monitors process health, and identifies improvement and waste-reduction opportunities. The role partners with Manufacturing, Engineering, Quality, and Compliance teams to maintain audit readiness, improve throughput and quality, and support compliant production operations.

Develop and scale lentiviral vector downstream purification processes for GMP manufacturing. Build mechanistic, hybrid, and AI-enabled models; apply engineering principles, machine learning, analytics, and advanced process control. Lead clarification, chromatography, and TFF development, technology transfer, troubleshooting, process optimization, and clinical manufacturing support. Author technical and regulatory documents while collaborating cross-functionally with upstream, analytical, manufacturing, CDMO, and global site teams.

Lead translational bioinformatics analyses integrating multi-omics and clinical data to discover and validate biomarkers, support patient stratification and mechanism-of-action hypotheses, build reproducible scalable pipelines (cloud/HPC), collaborate with cross-functional teams and contribute biomarker content for regulatory submissions.

Designs and analyzes executive compensation, incentive, bonus, equity, and retention programs. Conducts benchmarking, market intelligence, scenario modeling, pay mix analysis, and financial impact assessments. Supports executive compensation reporting, Compensation Committee materials, global compensation initiatives, job architecture, and leader communications. Partners with Finance, HR, business leaders, and global compensation teams to align rewards with business strategy, talent retention, and market competitiveness.

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.

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.