Principal Scientist, CMC Pipeline Innovation

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.

Legend Biotech is seeking a Principal Scientist, CMC Pipeline Innovation as part of the Technical Development team based in Somerset, NJ.

Role Overview

The Principal Scientist, CMC Pipeline Innovation is a lab-based role focused on advancing analytical innovation to support the development and manufacturing of pipeline therapies. This position emphasizes the evaluation, development, creation, and integration of advanced analytical technologies to improve method robustness, data quality, and operational efficiency across the product lifecycle.

The role involves contributing to internal innovation initiatives and participating in collaborations with external partners to enhance analytical workflows that support scalability, regulatory compliance, and cost-effectiveness. The individual may also support business case development for new technologies that improve patient access through better product understanding and control.

This position works closely with cross-functional teams to implement novel analytical approaches across the entire development pipeline, ensuring alignment with evolving regulatory expectations and emerging scientific advancements. A key aspect of the role includes designing and executing proof-of-concept studies across multiple modalities and development stages, demonstrating the feasibility, scalability, and impact of innovative analytical solutions. These studies inform strategic decisions, guide technology adoption, and ensure that innovation efforts are broadly applicable and sustainable across the full portfolio of pipeline programs.

Key Responsibilities

• Identify and address analytical gaps across pipeline programs by implementing innovative and strategic solutions.
• Scout, evaluate, create, and implement emerging analytical technologies aimed at improving sensitivity, specificity, throughput, turnaround time, and robustness of methods.
• Provide technical assessments and recommendations for new analytical platforms, including feasibility, risk, and implementation timelines.
• Design and execute lab-based proof-of-concept studies to demonstrate the value of novel analytical tools in characterizing complex biologics and cell therapies.
• Define roadmaps for integrating new analytical technologies across the entire portfolio lifecycle, from early development through commercialization.
• Collaborate with external partners and technology providers to evaluate new platforms and contribute to partnership strategies.
• Monitor industry trends, scientific literature, and regulatory guidance to stay at the forefront of analytical innovation.
• Collaborate across functions to ensure seamless integration of new analytical capabilities into development and quality systems.
• Contribute to regulatory submissions by providing technical documentation and justification for novel analytical approaches.
• Apply knowledge of analytical comparability to support product transitions across development stages.
• Cell culture, clonal isolation and banking.
• Empowered to define and guide technical direction, including the development of methodologies and detailed scientific or engineering approaches. Decision-making authority is focused on execution-level activities where technical innovation and precision are critical.

Requirements

• B.S., M.S., or Ph.D. in Analytical Chemistry, Biochemistry, Biology, Biomedical Engineering, or a related field with 8+ years of applied technical experience.

• Deep expertise in analytical method development and validation for complex cell/gene therapies.

• Familiarity with lentiviral vector (LVV) characterization assay development is highly desirable.

• Hands-on experience with advanced analytical platforms such as NGS, flow cytometry, nano flowcytometry and Capillary Gel Electrophoresis w/ Laser-Induced Fluorescence (CGE-LIF), ELLA, JESS, DLS, Leprechaun and advance Transcriptomic techniques (microarray, scRNA-Seq, etc.)

• In vitro PBMC based transduction assay and Potency assay development experience

• Experience with automation, data integration, and digital tools to enhance analytical workflows is a plus.

• Familiarity with Machine Learning & Artificial intelligence a plus

• Strong understanding of regulatory expectations for analytical methods in clinical and commercial settings.

• Excellent communication and collaboration skills to work across technical functions.

• IT Skills:

• Microsoft Office (Access, Excel, PowerPoint, Visio, Word, Project)

• JMP, GraphPad Prism, Smartsheet, R, SoftMax Pro

• LIMS

• FlowJo or equivalent

• English required; Mandarin is a plus.

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The anticipated base pay range is:

$142,146-$186,567 USD

Benefits:

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

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 applicable law.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.