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QC Analyst I/II

Legend Biotech

Raritan, New Jersey, United StatesEntry$68.0k/yr
Sign in to applyVerified 1h ago
Location
Raritan, New Jersey, United States
Work model
On-Site
Level
Entry
Salary
$68.0k/yr
Posted
1h ago

About this role

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 QC Analyst as part of the Quality Operations team based in Raritan, NJ.

Role Overview

The QC Analyst is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Key Responsibilities

• Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

• Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.

• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.

• Perform peer review/approval of laboratory data.

• Utilize electronic systems (LIMS) for execution and documentation of testing.

• Create, review and approve relevant QC documents, SOP’s and WI’s.

• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

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Listing verified 1h ago. Applications go through the company's official careers site.

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QC Analyst I/II at Legend Biotech, Raritan, New Jersey, United States | Yoinka