Jobs at Legend Biotech

Lead global preclinical development from candidate nomination through IND-enabling studies. Oversee in vitro/in vivo pharmacology and toxicology, integrate PK/PD/safety data for clinical dose and regulatory strategy, manage CROs, and build a high-performing preclinical team while ensuring scientific rigor and regulatory compliance.

Lead commissioning, qualification, and validation (CSV/CQV) of computerized systems and equipment for a cGMP cell therapy manufacturing site. Manage CSV/CQV projects, author and execute protocols and reports, support investigations and CAPAs, perform risk assessments, and ensure data integrity and regulatory compliance (21 CFR, EU Annex 11, ICH). Coordinate cross-functional teams and vendors to enable compliant production and release of cell-based therapies.

Oversee 2nd-shift production of personalized cell therapies in a sterile cGMP environment. Manage and develop staff, assign production schedules, maintain compliance and inspection readiness, support investigations and change control, create/revise operational procedures, partner with Manufacturing/Engineering/Quality, and lead continuous improvement projects to ensure high-quality product supply.

Manage 2nd-shift CAR-T cell therapy production in a sterile cGMP facility. Oversee supervisors and staff, ensure compliant manufacturing, maintain inspection readiness, support investigations and change controls, create/revise procedures and batch records, coordinate with Manufacturing/Engineering/Quality, drive continuous improvement projects, and lead operational metrics and stakeholder engagement.

Lead organization design, change management, and leadership development initiatives to improve organizational effectiveness. Partner with business leaders and HRBPs on workforce planning, talent and promotion processes, performance systems, and measurement of OD impact. Drive global programs, culture, and capability building for sustainable growth.

Lead site-level quality compliance for a GMP cell therapy manufacturing site, ensuring global GxP alignment, inspection readiness, audit management, CAPA/change control oversight, cross-functional collaboration with J&J, and continuous improvement of quality systems.

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.

The Operations Supervisor oversees daily production in a CAR-T cell therapy environment, ensuring compliance with cGMP regulations and leading a team to meet operational goals.

Lead nonclinical toxicology strategy for cell and gene therapy programs, design and interpret GLP safety, pharmacology, biodistribution, and PK studies, manage CRO studies, support IND/CTA and regulatory submissions, assess safety risks (off-target effects, immunogenicity, genome-related risks), and communicate findings across cross-functional teams.

The Manager, Site Contracts & Payments Management oversees the site contracting and payment processes, ensuring operational effectiveness and collaboration between stakeholders to improve efficiency and financial predictability in clinical studies.

Lead clinical biomarker programs in immunology and immuno-oncology for hematologic malignancies. Design and analyze clinical translational studies, define MOA, leverage single-cell technologies to profile immune compartments, partner cross-functionally to validate targets, inform patient stratification, and drive biomarker strategies for novel cell therapies.

Lead and supervise CAR-T process operations in a cGMP cleanroom environment. Direct daily production activities, run shift meetings, assign tasks, coach staff, support investigations, revise SOPs and batch records, manage change controls, collaborate with Manufacturing, Engineering, and Quality, and drive continuous improvement while ensuring safety and regulatory compliance. Must be able to perform production tasks as needed and accommodate shift work and overtime.

The Carvykti Financial Analyst will support financial planning and analysis, preparing reports, variance analysis, financial models, and partnering with business units for guidance and reporting improvements.

Lead design, optimization, and scale-up of upstream lentiviral vector production (HEK293/HEK293T), develop/validate bioreactor scale-up and scale-down models, enable tech transfer to GMP manufacturing, guide a team, author regulatory and technical documents, and collaborate with downstream and analytics to ensure robust, scalable processes for clinical production.

Provide scientific leadership and hands-on expertise in multicolor and spectral flow cytometry to develop, qualify, and validate assays supporting IND-enabling studies and clinical trials. Oversee CROs, ensure GxP-compliant data integrity, contribute to regulatory submissions, partner cross-functionally, mentor junior staff, and implement best practices and new technologies to support translational PK/PD and cell/gene therapy programs.

The Sr. Manager, Biostatistician/Programmer supports clinical development by analyzing clinical trial data, developing TFLs, and collaborating with various teams to inform decision-making.

The Translational IHC Consultant connects pathology and biomarker development, ensuring quality data for drug mechanisms, target engagement, and safety while collaborating with clinical teams to enhance cancer treatments.

The QA Investigations Lead oversees quality investigations in a GMP environment, ensuring compliance with regulations, managing CAPA, and supporting audits.

Design and implement scalable bioinformatics pipelines; analyze large multi-omics datasets (RNA-seq, scRNA-seq, WES/WGS, epigenetics) to identify biomarkers and targets; apply statistical and machine learning methods; perform QC, normalization, and batch-correction; integrate public and internal databases; collaborate with biologists, clinicians, and IT to translate computational results into biological insights.

Lead commercial strategic relationships with societies, associations, and scientific organizations to elevate Legend's market presence. Develop and execute external engagement and US strategic business plans, manage multiple projects, translate customer insights into commercial strategies, oversee budgets and resource allocation, and drive organizational upskilling and decision-making as a member of the Commercial Leadership Team.