Scientist I, Analytical Development
$96.27k - $126.35kLegend Biotech US
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 Scientist I, Analytical Development as part of the Research and Development team based in Somerset, NJ. Role Overview We are seeking a dynamic and scientifically driven Scientist I 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 5 or more years of relevant experience, or Master’s degree with 3 to 5 years of experience, or PhD with 0 to 2 years of experience. 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. GraphPad Prism, other data analysis tools (PowerBI, JUMP, R). Language(s): Strong written and verbal English skills are required. Mandarin preferred.
- Li-RP1
- Li-Onsite
$96,267 - $126,351 USD
Please note: These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech. 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. Please print your name if you agree to the terms and conditions set forth in the applicant Non‑Disclosure Agreement. Access to Company Confidential Information. I acknowledge that for the sole and limited purpose of evaluating a possible employment relationship with me, the Company might disclose, or enable me to have access to, certain Confidential Information of the Company, as defined below. I agree that, except for purposes of evaluating a possible employment relationship with the Company or as expressly authorized in writing by the Company, I will (a)not use or disclose any Confidential Information; (b)keep all Confidential Information confidential at all times; and (c)not copy, reproduce or modify any Confidential Information. Definition of “Confidential Information.” For purposes of this Agreement, “Confidential Information” shall mean any and all information and materials provided to me by the Company, including without limitation, inventions, trade secrets, software code, product development and marketing strategies, ideas, processes, formulas, know‑how, unpublished financial information, business plans, contractual relationships with third parties and operating strategies; memoranda, notes, records, drawings, manuals, disks, or other documents and media; and all embodiments, copies, extracts, and summaries thereof; provided, however, that “Confidential Information” shall not include information that: (a) is generally known or available to the public, or (b) is furnished to me by a third party who obtained such information using lawful means and without any restrictions on disclosure. Third Party Information. I agree that during the course of communications with the Company pursuant to this Agreement or in connection with my application and interviews for employment with the Company, I will not make any unauthorized use or disclosure to the Company of any confidential or proprietary information or trade secrets of any other person or entity to whom I have an obligation of confidentiality with respect to such information, including any current or former employer. I further agree not to provide to the Company any materials or documents of any third party that are not generally available to the public. Remedies for Breach. I acknowledge that in the event of any breach of this Agreement, the Company will not have an adequate remedy in money or damages, and therefore the Company shall be entitled to obtain temporary, preliminary and/or permanent injunctive relief to redress any such breach, from any court of competent jurisdiction, and that the Company’s right to obtain such relief shall not limit its right to obtain other available remedies. General. The interpretation and enforcement of this Agreement shall be governed by the laws of the State of California. This Agreement constitutes the entire agreement between the parties concerning the subject matters hereof; it supersedes any and all prior agreements or representations, written or oral, with respect to its subject matters; and it cannot be modified except in a written agreement signed by the Company. #J-18808-Ljbffr Legend Biotech US$96.27k - $126.35k
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