Legend Biotech is seeking a Senior Principal/Principal Scientist - NGS & Molecular Assays (Cell & Gene Therapy) as part of the Bioanalytic Sciences team based in Somerset, NJ.

Role Overview

We are seeking an experienced and highly motivated Bioanalytical Lead to develop and oversee molecular and NGS-based assays supporting preclinical IND-enabling through clinical-stage cell and gene therapy programs. This role will focus on
autologous and allogeneic CAR-T, NK, T, and in vivo CAR-T gene editing therapies. The ideal candidate will have expertise in NGS, gene editing analysis (on/off-target), qPCR/ddPCR, and viral vector integration site analysis. This role involves designing and executing cutting-edge sequencing experiments, leading data analysis efforts, managing external vendors, and ensuring regulatory compliance.

Key Responsibilities

NGS & Molecular Assay Development and Execution

Lead and execute NGS-based assays for gene editing and cell therapy applications, including:
- Guide-seq, RhAMP-seq, PEM-seq, UDiTas related to on/off-target gene editing analysis.
- LVV/RVV integration analysis for lentiviral and retroviral vector insertion site profiling.
- TCR-seq and BCR-seq to assess TCR/BCR clonality in engineered cell therapies.
Critically review and evaluate on/off-target gene editing analysis reports from internal teams and CROs.
Design and execute single-cell RNA sequencing (scRNA-seq) experiments using patient-derived cells.
Develop and validate qPCR/ddPCR assays for CAR transgene quantification and vector copy number analysis.
Work with cross-functional teams to address key efficacy, safety, and product integrity questions regarding gene-modified cell therapies.

NGS Data Analysis & Bioinformatics

Lead bioinformatics analysis of sequencing data, including single-cell RNA-seq, TCR-seq, BCR-seq, and off-target gene editing analysis.
Ensure data quality control and interpretation using industry-standard bioinformatics tools and pipelines.
Collaborate with computational biology teams to develop and optimize data analysis pipelines for NGS-based bioanalytical assays.

Vendor & CRO Oversight

Work with CROs for sample submission, assay development, validation, and data transfer.
Ensure compliance with quality and regulatory requirements for outsourced bioanalytical testing.
Troubleshoot and resolve technical and compliance-related issues with vendors.

Regulatory & Compliance

Maintain up-to-date written documentation of completed experiments in an electronic lab notebook.
Ensure bioanalytical assays align with global regulatory guidelines (FDA, EMA, ICH) for gene editing and cell therapy products.
Support regulatory submissions (IND, BLA) by providing bioanalytical data and justifications for assay selection and validation strategies.

Requirements

Technical Expertise:
Expertise in NGS techniques including single-cell RNA sequencing (scRNA-seq), library preparation, sequencing platforms, and data analysis.
Hands-on experience in gene editing tools (CRISPR-based) and genetic modification of human primary cells or cell lines.
Experience in designing and executing on- and off-target analysis assays, including Guide-seq, RhAMP-seq, PEM-seq, UDiTas.
Knowledge of LVV/RVV integration analysis and immune repertoire sequencing (TCR-seq, BCR-seq).
Experience with qPCR/ddPCR assays for CAR transgene quantification and genomic characterization.
Strong understanding of immune cell isolation, purification, and molecular biology techniques relevant to NGS.

Bioinformatics & Data Analysis:

Proficiency in bioinformatics tools for NGS data analysis, quality control, and interpretation.
Familiarity with genome editing readouts and computational tools for off-target evaluation.

Industry & Regulatory Knowledge:

Experience managing CROs and external vendors for bioanalytical assay development and validation.
Working knowledge of GLP, GCP, and regulatory expectations for gene and cell therapy bioanalytical assays.
Prior involvement in regulatory submissions (IND, BLA) and regulatory agency interactions.

Soft Skills & Collaboration:

Ability to work cross-functionally with Research, Translational Science, Process Development, and Clinical teams.
Excellent communication and problem-solving skills in a fast-paced, collaborative environment.

If you are passionate about advancing bioanalytical science for next-generation cell and gene therapies, we encourage you to apply!

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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.