Document Management Specialist I/Ii

Company Information

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 and natural killer (NK) cell-based immunotherapy.

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) in 2017. 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.

Legend Biotech is seeking Document Management Specialist I/II as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Document Management Specialist will provide oversight of all GMP documents and ensure that all documents are updated and effective in alignment with the needs of CAR-T Operations and document lifecycle management. They will be responsible for prescribing the correct training based on the type of changes made and managing printing of documentation and labels required for Technical Protocol runs.

Key Responsibilities

• Oversight of the introduction of new SOPs in time to support Manufacturing Strategy.
• Oversight of the revision process of existing SOPs in time to support Manufacturing Strategy.
• Ensure periodic log book reviews are complete.
• Assist with Audits, as needed.
• Ensure proper training is prescribed as per the document changes made.
• Stay current regarding industry standards and ensure that all GMP documents are cutting edge and incorporate all latest regulatory and quality requirements.
• Ensure periodic review of all GMP documents are completed on time.
• Liaison with Operations, Technical Operations and QA to ensure alignment of changes.
• Track relevant KPIs.
• Continuous improvement of all GMP documents to ensure they are streamlined and robust, easy to use and intuitive; to help ensure maximum prevention of operational errors and quick turnaround times.
• Ensure Master Batch Record changes are made in time to support Manufacturing Strategy.

Requirements

• TrackWise knowledge is a plus.
• Knowledgeable in electronic Document Repositories and LMS (Learning Management Systems).
• Pharmaceutical GMP's – strong knowledge of Good Manufacturing Practices and regulatory knowledge is a requirement.
• Bachelor’s degree in Science, Engineering or related field or equivalent experience required.
• 3-5 or more years of related experience in cGMP/FDA regulated industry.
• Proficient in MS Office applications and other related IT Systems.

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), 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.

Benefits:

• Hospital Indemnity Insurance
• Health Insurance
• Short-Term Disability
• AD&D Insurance
• Paid Paternity Leave
• Life Insurance
• Health Savings Account
• Long-Term Disability
• Vision Insurance
• Matched 401K
• Paid Maternity Leave
• Legal Insurance
• Pet Insurance
• Commuter Benefits
• Employee Assistance Program
• Flexible Spending Account
• Critical Illness Insurance
• Accident Insurance
• Dental Insurance