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. 

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