Description

Legend Biotech is seeking a Sr. Principal/Principal Scientist as part of the Research & Early Development team based in Somerset, NJ.

Role Overview

Legend Biotech is seeking a highly experienced Senior Principal Scientist / Principal Scientist - Flow Cytometry to provide scientific leadership and hands-on expertise in flow cytometry to support cell and gene therapy programs from IND-enabling studies through early- and late-stage clinical development. This role is critical for ensuring scientific rigor, data quality, and strategic insight across in-house and outsourced flow cytometry activities, including assay development, validation, CRO oversight, and deep data interpretation to support translational, PK/PD, and regulatory decision-making.

Key Responsibilities

Scientific & Technical Leadership

• Lead the design, development, optimization, qualification, and validation of multicolor and spectral flow cytometry assays supporting IND-enabling animal studies and clinical trials.
• Provide subject-matter expertise in panel design, antibody and reagent qualification, gating strategies, and data analysis for complex immunophenotyping applications.
• Conduct deep scientific review and interpretation of flow cytometry datasets to support PK/PD, mechanism-of-action, and translational insights.

CRO & Vendor Oversight

• Serve as the primary scientific lead for external laboratories and CROs performing flow cytometry assays.
• Oversee assay transfer, validation, execution, troubleshooting, and data delivery at CROs.
• Ensure outsourced activities meet Legend quality standards, regulatory expectations, and program timelines.
• Identify risks related to assay performance, data quality, and operational execution, and implement mitigation strategies.

Regulatory & Compliance

• Author, review, and approve bioanalytical assay validation reports, study reports, and regulatory documentation.
• Ensure flow cytometry assays and data packages are inspection-ready and compliant with GxP principles and data integrity requirements.
• Contribute to bioanalytical sections of IND and other regulatory submissions.

Cross-Functional Collaboration

• Partner with Clinical, Translational Research, Biomarkers, Nonclinical Safety, and Data Science teams to align assay strategy with program objectives.
• Provide scientific input to study design, endpoint selection, and interpretation of bioanalytical results.
• Communicate complex data clearly to multidisciplinary stakeholders.

Operational Excellence & Mentorship

• Establish and maintain SOPs, best practices, and governance for in-house flow cytometry workflows.
• Mentor and scientifically guide junior scientists and associates.
• Evaluate and implement new technologies, platforms, and analytical approaches to enhance capabilities.

Requirements

• Ph.D. in Immunology, Cell Biology, Molecular Biology, or related discipline with 8+ years (Principal Scientist) or 10+ years (Senior Principal Scientist) of relevant industry experience; or M.S. with 12+ years of experience.
• Extensive hands-on experience with multicolor and spectral flow cytometry platforms.
• Demonstrated experience supporting cell therapy and/or gene therapy programs.
• Strong understanding of bioanalytical method development, validation, and regulatory expectations.
• Proven ability to lead complex programs, influence cross-functional teams, and provide strategic scientific direction.
• Experience overseeing CROs and external vendors.
• Excellent written and verbal communication skills.
• Experience with CAR-T, in vivo gene delivery, or other advanced cell therapy platforms.
• Experience contributing to IND-enabling or regulatory filings.
• Background in translational PK/PD applications of flow cytometry.

#Li-JR1

#Li-Hybrid

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

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