Risk & Validation Specialist - ICH Q9 (Equity Eligible)

Company Overview Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across diverse 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 worldwide, we apply these 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 (Johnson & Johnson) to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel), a promising immunotherapy for multiple myeloma. Position 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; 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. Qualifications BS degree in Biology, Biotechnology, Chemistry, Engineering, or related technical field (foreign equivalence acceptable). 12 months of experience as a Risk Assessment Specialist, Project Manager, Data Analyst, or related occupation. Proficiency with risk assessment tools such as FMEA, FTA, Pareto analysis, HAZOP, and/or HACCP. Less than 5% travel required, monthly. Compensation & Benefits Base pay: $81,037 per year. Performance‑based bonus and/or equity available to employees in eligible roles. Benefits and Paid Time Off: Medical, dental, and vision insurance; 401(k) retirement plan with company match that vests fully on day one; eight weeks of paid parental leave after three months of employment; paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven 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. Application To apply, please email your CV to View email address on click.appcast.io. 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. Employment 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