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Principal Scientist, Functional Assays, Analytical Development

Somerset, New Jersey, United States

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 Principal Scientist, Functional Assays,  Analytical Development as part of the Technical Development team based in Somerset, NJ. 

Role Overview

We are seeking a dynamic and scientifically driven Principal Scientist to join the Functional Assays and Flow Cytometry team within our empowered Analytical Development organization. This role will focus on the establishment, development and qualification of cell-based potency assays, flow cytometry-based methods, and other bioanalytical strategies to support the release and characterization of cell therapy products (multiple types of cell product, in vivo vector product, etc.). The ideal candidate will be a hands-on leading scientist, capable of mentoring junior scientists while also contributing strategically to cross-functional collaborations with other functional teams.

Key Responsibilities  

  • Focus on functional assay development, including potency (cell-based), flow cytometry, and bioanalytical (e.g., ELISA) assays.
  • Guide method development activities to support phase-appropriate analytical deliverables (including potency, purity, safety, etc.) with an emphasis on scientific rigor, data integrity, and patient-centricity.
  • Drive the timely tech transfer of assays from R&D to GMP/QC environments.
  • Identify and refine critical parameters and material/reagents during assay prequalification activities; generate critical materials including cell banks.
  • Design, develop, and optimize cell-based analytical assays (e.g., cell killing assay, cytokine releasing assay, infectious titer assay, etc.).
  • Drive the development and qualification of release assays for early-phase clinical programs, including First-In-Human (FIH) trials, and ensure execution on aggressive timelines.
  • Ensure the generation of standard operating procedures (SOPs) and laboratory protocols that support QC release testing and product development.
  • Collaborate cross-functionally with QC and Manufacturing teams to ensure seamless assay execution, troubleshooting, and continuous improvement.
  • Review and author technical reports and peer-reviewed scientific publications.
  • Present scientific data and trends at internal and external forums.
  • Ensure proper documentation practices including lab notebooks, QC records, and equipment maintenance logs.

Requirements

  • Advanced degree (PhD) in immunology, cell biology, biomedical engineering, or equivalent. Technical training / certification is desirable.
  • 8+ years of experience in method development of gene-modified products in analytical development and/or QC in a biotech, academic, or pharmaceutical setting
  • Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
  • Expertise in analytical method development and qualification/validation is required.
  • Experience in developing multicolor flow cytometry methods, cell culture including reporter gene cell line development, potency assays, cytotoxicity assays and cytokine release assays, immunoassays, infectious titer assays
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
  • Solid understanding of ICH guidelines and regulatory expectations for method qualification. Guide the design and execution of method qualification.
  • Guide the establishing and authoring of SOPs/procedures for established methods
  • Demonstrated ability to lead, mentor, and develop scientific staff in a matrixed and collaborative environment.
  • Detail-oriented with expertise in problem solving and solid decision-making abilities

#Li-JR1

#Li-Hybrid

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.

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