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    Cqv Specialist-Contractor

    Legend Biotech Us
    2+ years
    Not Disclosed
    Raritan
    10 June 3, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Company Information

    Legend Biotech
    Headquartered in Somerset, New Jersey, Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. We develop advanced cell therapies across various technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. In 2017, Legend Biotech entered into a global collaboration agreement with Janssen, one of Johnson & Johnson's pharmaceutical companies, to jointly develop and commercialize ciltacabtagene autoleucel (cilta-cel) for the treatment of multiple myeloma.

    Job Title: CQV Specialist (Contract Position)

    Location: Raritan, NJ
    Department: Technical Operations

    Role Overview

    The CQV Specialist will provide Commissioning, Qualification, and Validation support for the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. The role involves day-to-day activities such as execution, protocol management, vendor management, addressing issues and deviations, and remediation efforts for facility, equipment, systems, and processes to support compliant manufacturing operations according to cGMP requirements. The specialist will work independently and collaboratively across cross-functional groups to establish a robust CQV program, ensuring the production, testing, and release of products to patients.

    Key Responsibilities

    • CQV Execution: Perform commissioning, qualification, requalification, validation, and associated maintenance activities within the plant.
    • Project Management: Manage multiple complex CQV projects, provide status reports, and coordinate with other departments or external contractors/vendors to complete tasks.
    • Technical and Quality Investigations: Support and/or lead technical and quality investigations, CAPAs, and corrections.
    • Remediation Efforts: Develop and perform required remediation efforts and associated CAPA plans.
    • Documentation: Author, own, and execute master and completed CQV protocols, summary reports, and associated data ensuring conformance to regulations, SOPs, specifications, and other acceptance criteria, focusing on data integrity.
    • Change Controls and SOPs: Execute, own, assess, and participate in the creation, revision, and review of change controls, SOPs, and other documentation.
    • Risk Assessments and Reports: Participate in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.

    Requirements

    • Education: Bachelor’s Degree in Science, Engineering, or equivalent technical discipline.
    • Experience: Minimum of 2 years relevant work experience. Preferably with experience in an aseptic manufacturing facility, cell therapy, testing facility, quality assurance, or manufacturing compliance.
    • Knowledge: Understanding of cGMP regulations, FDA/EU guidance related to cell-based product manufacturing, and Good Tissue Practices.
    • Skills:
      • Strong interpersonal and written/oral communication skills.
      • Ability to quickly process complex information and make critical decisions with limited information.
      • Proficient in applying process excellence tools and methodologies.
      • Ability to manage multiple projects independently.
      • Highly organized with attention to detail.
      • Ability to work effectively in a team environment with a positive attitude.
      • Good written and verbal communication skills.
      • Ability to summarize and present results.
      • Experience with team-based collaborations.
      • Knowledge of current Good Manufacturing Practices (cGMP) and Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
      • Ability to identify and remediate process or system gaps.
      • Experience with ICH and/or 21 CFR parts 210, 211, 1271, and preferably 600, 601, and 610.
      • Experience authoring and executing documentation, including Batch Records, SOPs, Work Instructions, and CQV protocols.
      • Experience with TrackWise, CMMS, and Maximo.
      • Proficient with Microsoft Office applications (Outlook, Excel, Word, PowerPoint).

    Additional Information

    Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. We ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex, sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

    Legend Biotech maintains a drug-free workplace.

    For more information, visit our website at Legend Biotech.

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