QC Specialist, Lab Services, II/III

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Role Overview The QC Specialist, Lab Services is responsible for sample management. The Specialist is encouraged to work independently on routine tasks and has a conceptual understanding of all Quality Control functions and business areas. May need supervision or support to resolve more sophisticated issues. The role requires logical thinking and decisive action. Shift schedule: Thursday‑Saturday 4:00 pm – 4:00 am. Key Responsibilities Prepares and reviews documentation independently. Responsible for QC sample and retain management. Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems. Proficient with Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS). Prepare documents and coordinate sample shipment (internal and external). Review logbooks and/or LIMS to align physical quantities of samples in freezers/refrigerators. Periodic inspection and consolidation of retains. Document and perform sample management related non‑conformance investigations. Document and handle corrective and preventative action records. Supports internal and regulatory audits. Requirements Minimum of a Bachelor’s degree or higher. Minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry. Degree in Biology, Biochemistry, Microbiology, Chemistry or related field. Solid understanding of regulatory requirements, policies and guidelines. Experience with Quality Control document reviews and regulatory inspection processes. Working knowledge of Quality systems. Experience in management of retain samples using electronic systems (eLIMS). Candidates must be able to accommodate shift schedule, including weekend and evening work as required by the manufacturing process. Position located in Raritan, NJ with up to 5% travel. Position occasionally requires lifting up to 20 pounds. Compensation and Benefits Base pay range: $68,045 – $102,705 USD. Additional pay may include performance‑based bonus and/or equity. Benefits for permanent full‑time employees include medical, dental, and vision insurance; 401(k) retirement plan with company match; eight (8) weeks of paid parental leave after three (3) months of employment; paid time off policy with vacation, personal, sick, floating holidays, and eleven (11) company holidays; and a range of voluntary benefits including flexible spending accounts, health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, supplemental insurance options, commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs. 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. #J-18808-Ljbffr Legend Biotech US