Scientist II, Analytical Development, Flow, Function and Bioanalytical Assays

Scientist II, Analytical Development, Flow, Function and Bioanalytical Assays

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, our portfolio spans cell therapies across autologous and allogenic T cell, TCR-T, and natural killer (NK) cell platforms to discover safe, efficacious, and cutting edge therapeutics for patients worldwide.

We are seeking a dynamic and scientifically driven Scientist II to join the Flow Cytometry and Functional Assays team within our Analytical Development organization. This role focuses on establishing, developing, and qualifying flow cytometry based methods, cell based potency assays, and bioanalytical strategies to support release, characterization, and stability assessment of cell therapy products, including multiple cell products and vector products.

The position reports directly to a Principal Scientist in Analytical Development.

• Develop, optimize, and execute assays, including potency, flow cytometry, and bioanalytical assays (e.g., ELISA).
• Develop and qualify analytical methods for LVV characterization, infectious titer assays, vector potency assays, and vector specific flow cytometry panels.
• Transfer methods to QC, perform pre qualification and qualification activities, refine critical parameters, and generate critical materials such as cell banks.
• Generate SOPs and laboratory protocols that support product release testing and characterization.
• Collaborate with PD, QC, and Manufacturing teams to ensure seamless assay execution, troubleshooting, and continuous improvement.
• Present scientific data and trends at internal and external forums.
• Maintain proper documentation practices, including ELN, test method development plans, reports, and equipment maintenance logs; contribute to laboratory inventory management.
• Manage multiple projects concurrently, meeting timelines while upholding quality and data integrity.
• Make decisions on assay development planning and execution; seek higher level approvals for significant methodological changes or cross functional collaborations.

• PhD or Master's in a scientific discipline or equivalent engineering background, plus 2-5 years of related experience (post doctoral experience acceptable); expert knowledge of scientific principles.
• Expertise in analytical method development and qualification validation.
• Experience developing multicolor flow cytometry methods, cell culture (including reporter gene line development), potency assays, cytotoxicity assays, cytokine release assays, immunoassays, and infectious titer assays.
• Experience with LVV residual impurities assays.
• Demonstrated independent judgment in method development, technique selection, and evaluation criteria.
• Solid understanding of ICH guidelines and regulatory expectations for method qualification; ability to design and execute qualification plans.
• Experience authoring SOPs and procedures for established methods.
• Detail-oriented with strong problem solving and decision-making skills.
• Excellent presentation and scientific/technical writing abilities.
• Proficiency with Graph Pad Prism and other data analysis tools (PowerBI, JUMP, etc.).
• Language:
  English preferred;
  Mandarin is a plus.

Base pay range: $110,706 – $145,303 USD, with performance based bonus and/or equity available. Medical, dental, and vision insurance; 401k plan with company match; eight weeks of paid parental leave after three months; paid time off policy that includes vacation, personal, sick, floating holidays, and eleven company holidays; voluntary benefits such as FSA, HSA, life AD&D, disability, legal assistance, and supplemental plans.

Commuter benefits, family planning resources, well being initiatives, and recognition programs are also available.

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

Legend Biotech provides 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, 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.