Risk Assessment Specialist

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. Position Overview Legend Biotech USA, Inc. seeks a Risk Assessment Specialist in Raritan, NJ to conduct Quality Risk Assessments (QRM per ICH Q9) for manufacturing processes, QC systems, and equipment, applying methodologies such as FMEA, HACCP, HAZOP, and Pareto analysis; develop, execute, and review validation master plans, cleaning validation, and method transfer protocols; prepare and review technical documentation; collaborate with QA, QC, Manufacturing, Engineering, and R&D teams; analyze data from risk assessments and validation studies, identify gaps, and recommend actions; track and report progress on risk assessment activities; provide subject matter expertise on ICH Q9 Quality Risk Management, FDA, and cGMP compliance; perform related duties as assigned to maintain compliance with FDA, ICH, and GMP standards. Responsibilities Conduct Quality Risk Assessments (QRM per ICH Q9) for manufacturing processes, QC systems, and equipment, using methodologies such as FMEA, HACCP, HAZOP, and Pareto analysis. Develop, execute, and review validation master plans, cleaning validation, and method transfer protocols. Prepare and review technical documentation. Collaborate with QA, QC, Manufacturing, Engineering, and R&D teams. Analyze data from risk assessments and validation studies, identify gaps, and recommend actions. Track and report progress on risk assessment activities. Provide subject matter expertise on ICH Q9 Quality Risk Management, FDA, and cGMP compliance. Perform related duties as assigned to maintain compliance with FDA, ICH, and GMP standards. Requirements BS degree in Biology, Biotechnology, Chemistry, Engineering, or a related technical field (foreign equivalent acceptable). 12 months of experience as a Risk Assessment Specialist, Project Manager, Data Analyst, or related occupation. Required skills in risk assessment tools such as FMEA, FTA, Pareto analysis, HAZOP, and/or HACCP. Travel less than 5% of time as needed, monthly. Salary: $81,037 per year. E‑Mail CV to Legend Biotech USA, Inc. at View email address on click.appcast.io. Compensation and Benefits Pay Range (Base Pay): $81,037—$81,037 USD. Other Types of Pay: Performance‑based bonus and/or equity is available to employees in eligible roles. Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs. Please note: These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech. 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 Terms Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. For information related to our privacy notice, please review: Legend Biotech Privacy Notice. #J-18808-Ljbffr Merck & Co.