Scientist II, Analytical Development

BioNJ Inc.; New Jersey; On-site; USD 95,000 - 140,000; Full time

Job summary

Legend Biotech in Somerset, NJ is seeking a Scientist II, Analytical Development to join the Technical Development team. You will establish and qualify analytical methods including flow cytometry, cell-based potency, and immunoassays to support cell and gene therapy programs.

The role involves method development, execution for product characterization, release and stability testing, and authoring/reviewing documents. Collaboration with PD, QC and Manufacturing is essential.

Qualifications

• Bachelor's degree with 7+ years, or Master's 5–7 years, or PhD 2–4 years, or post-doc.
• Strong background in flow cytometry, cell culture, ELISA and cell-based assays.
• Experience with compendial methods is preferred.
• Knowledge of ICH guidelines and regulatory expectations for method qualification.

Responsibilities

• Develop, optimize, and execute analytical methods for viral vector and CAR-T characterization.
• Author and review methods, protocols, and reports.
• Maintain reagent inventory and qualify materials for methods.
• Transfer methods to QC and external collaborators; receive methods from others.
• Maintain ALCOA+ compliant electronic records and audits.
• Collaborate with PD, QC, and Manufacturing to ensure assay success.
• Present scientific data at internal and external forums.
• Balance multiple projects to meet timelines.

Skills

Flow cytometry

Mammalian cell culture

ELISA

Cell-based assays

Data analysis tools

GraphPad Prism

FlowJo

R

Education

Bachelor's degree

Master's degree

PhD

Tools

Excel

PowerPoint

GraphPad Prism

FlowJo

R

PowerBI

NovoExpress

FCS Express

LabVantage

Job description

Legend Biotech is seeking a Scientist II, Analytical Development as part of the Technical Development team based in Somerset, NJ.

Role Overview

We are seeking a dynamic and scientifically driven Scientist II to join Functional, Flow Cytometry and BioAnalytics team within our empowered Analytical Development organization. This role will focus on the establishment, development and qualification of analytical methods, including compendial methods, flow cytometry, cell-based potency, and immunoassays to support the development and manufacture of Legend's cell and gene therapy pipeline. This laboratory-focused role will require that candidates develop, optimize and execute analytical methods for product characterization, release and stability testing. This role will require authoring and reviewing documents, maintaining electronic laboratory notebooks, and contributing to cross-functional collaboration with other functional teams.

Key Responsibilities

• Develop, optimize, and execute analytical methods to support viral vector and CAR-T product characterization, including compendial methods, titer, particle size, flow cytometry, and cell-based potency methods.
• Author and review methods, protocols, and reports.
• Maintain reagent inventory and order materials as laboratory activities require.
• Generate and qualify critical materials for analytical methods.
• Observe all laboratory safety standards including PPE use and BSL2 best practices.
• Performing pre-qualification, assay qualification, product release testing, and product characterization testing in a quality control environment.
• Technology transfer of methods to QC and external collaborators and receive methods from internal and external collaborators.
• Maintain contemporaneous and accurate electronic laboratory records, including instrument maintenance records and sample inventory, following ALCOA+ standards.
• Perform peer review and data integrity reviews in the analytical development and quality control environments.
• Collaborate cross-functionally with PD, QC and Manufacturing teams to ensure seamless assay execution, troubleshooting, and continuous improvement.
• Present scientific data at internal and external forums.
• Balance multiple projects while meeting established timelines.
• This role is empowered to make decisions related to day-to-day planning and execution of assay development runs according to timelines determined at the group level. Collaboration, consensus and alignment with management are required for decisions related to methodology, assay development strategy, or interactions with other functional teams.

Requirements

• Bachelor's degree in a related field with 7 or more years of relevant experience, or Master's degree with 5 to 7 years of experience, or PhD with 2 to 4 years of experience or relevant post-doctoral research.
• Strong laboratory background, including experience with developing flow cytometry, mammalian cell culture, ELISA, and cell-based assays.
• Experience implementing or executing compendial methods is preferred.
• Experience with lentiviral vector characterization, including infectious titer, potency, and transduction efficacy assays.
• Solid understanding of ICH guidelines and regulatory expectations for method qualification.
• Experience with assay qualification, release testing and product characterization testing in a regulated environment.
• Experience with document change management and document review/approval workflows is preferred.
• Guide the establishing and authoring of SOPs/procedures for established methods
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Excellent verbal and written communication skills.
• Experience in:
  • Excel, Word, PowerPoint, etc
  • GraphPad Prism, other data analysis tools (PowerBI, JUMP, R)
  • CytoExpert, FCS express, NovoExpress, FlowJo, etc
  • ELN, LabVantage, etc
• Language(s): Strong written and verbal English skills are required. Mandarin preferred.
• AI Literacy: Possesses a working knowledge of AI technologies and approved AI tools, applies them responsibly to enhance productivity and decision-making, exercises appropriate human oversight of AI-generated outputs, and complies with organizational policies governing AI use.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

#Li-JR1

#Li-Onsite

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide 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 (including transgender status), 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.

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

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