Senior Scientist, Analytical Development (FFBA)

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.

Legend Biotech is seeking a Senior Scientist Analytical Development (FFBA) as part of the Technical Developmentteam based in Somerset NJ.

Role Overview

We are seeking a dynamic and scientifically driven Senior Scientist to join our empowered Analytical Development organization. This role will focus on the establishment development and qualification of analytical assays including but not limited to flow cytometry-based methods cell culture-based methods immunoassays compendial methods and other bioanalytical strategies to support the development and manufacturing of Legends pipelines. 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 and deeply understanding of GxP requirement.

Key Responsibilities

• Develop optimize and execute analytical methods to support cell and gene therapy product releasing and characterization including but not limited to compendial methods titer particle size flow cytometry cell-based potency or functional methods 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 collaborators to AD and/or from AD to QC and external collaborators.
• Identify and refine critical parameters and material/reagents during assay prequalification activities; generate and qualify critical materials including but not limited to cell banks.
• Drive the development and qualification of release assays for early-phase clinical programs and ensure execution on aggressive timelines.
• Author and review analytical related documentation including but not limited to analytical methods SOPs protocols and reports.
• Performing pre-qualification assay qualification product release testing and product stability testing in a quality control environment.
• Collaborate cross-functionally with QC PD and Manufacturing teams to ensure seamless assay execution troubleshooting and continuous improvement.
• Present scientific data and trends at internal and external forums
• Ensure proper documentation practices including lab notebooks QC records and equipment maintenance logs.
• Balance multiple projects while meeting established timelines.
• This role is empowered to make independent decisions related to the planning execution analysis and troubleshooting of analytical method development qualification transfer and characterization activities within established project timelines and departmental objectives. The Senior Scientist is expected to exercise scientific judgment in experimental design data interpretation risk assessment and the recommendation of technical solutions to complex analytical challenges. Collaboration consensus and alignment with management are required for decisions that may impact program strategy regulatory submissions project timelines resource allocation quality systems or cross-functional development activities. The position is also expected to provide technical guidance to junior staff and contribute to scientific decision-making across multidisciplinary project teams.

Requirements

• Advanced degree (PhD or Master) in immunology cell biology biomedical engineering or equivalent. 5-8 years (PhD) or 8-10 years (Master) of experience in method development of gene-modified products in analytical development and/or QC in a biotech or pharmaceutical setting. Technical training / certification is desirable.
• Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Expertise in analytical method development and qualification is required (Vaccine Biologics Viral Vector or CGT).
• Solid understanding of ICH guidelines and regulatory expectations for method development and qualification/validation.
• Expertise in analytical method development and validation in late stage is preferred.
• Experience in analytical comparability strategy method bridging method transfer activities for early and late phase in product development. Global experience is a plus.
• Experience in developing lentiviral vector product releasing and characterization methods including 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.
• Deep understanding and experience in analytical data trending critical reagent and material determination and qualification establishment of product releasing specification for early and late stage product development.
• Guide the establishing and authoring of SOPs/procedures protocols and reports for analytical methods and activities.
• Authorship in IND/BLA preparation is preferred.
• Demonstrated ability to lead mentor and develop junior staff in a matrixed and collaborative environment.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Experience implementing or executing compendial methods (HPLC Ph Osmolality Particulate Matter etc) is preferred.
• Excellent presentation skills scientific/technical writing skills and communication skills.
• Guide the establishing and authoring of SOPs/procedures for established methods.
• Experience with:
  • 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.

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

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.