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.

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Legend Biotech is seeking Title as part of the Department team based in Location.

REQUIREMENTS

• Bachelor’s degree required in Life Sciences or Engineering, with 6+ years Biotech/Pharmaceutical experience or equivalent industry experience Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices
• Great attention to detail and ability to follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Good written and verbal communication skills are required.
• Ability to collaborate well with stakeholders, customers, and peers.
• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
• Is frequently required to communicate with coworkers.
• While performing the duties of this job, the employee is regularly required to stand, walk; climb, bend, and stoop; and reach with hands and arms.
• Ability to lift 20 lbs.
• Report on working on time and according to the company policy.
• Perform other duties as assigned.
• Attend departmental and other scheduled meetings.
• Practice good interpersonal and communication skills.
• Demonstrate positive team-oriented approach in the daily execution of procedures.
• Promote and work within a team environment.
• Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
• Strong proficiency utilizing electronic Quality Systems per curriculum.
• Utilizes tools within MS Office and other systems to improve business effectiveness.
• Support and contribute to projects.
• Assist in troubleshooting issues related to manufacturing and batch release.
• Interpret a variety of instructions furnished in written, oral, or diagram.
• Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process.
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.
• Read and interpret documents such as safety rules, operating instructions and logbooks.
• Review and provide feedback for SOPs
  

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ROLE OVERVIEW

This exempt-level position is responsible for performing a wide range of activities to support the release of CAR-T drug product for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

KEY RESPONSIBILITIES

• Lead the team responsible for QA oversight of final CAR-T product batch record review and release practices.
• Lead the establishment and improvement of QA practices to ensure accurate documentation of all review and release activities, including manual and electronic practices.
• Establish and implement cGMP procedures to ensure compliant practices from all employee participating in the release process.
• Work in a team based, cross-functional environment to complete tasks required to meet business objectives.
• Support HR supervisory activities for designated team members.
• Support Investigations team by providing quality and compliance input for continuous improvement; and remediations.
• Lead quality driven continuous improvement projects to reduce turnaround time for batch review / release.
• Require minimal direction to complete tasks, know how to attain resources and information from established internal contacts; consult with manager for decisions outside of established procedures.
• Provide direction to the batch review/ release team to meet department and business goals.
• Maintain Batch Status Spread Sheets up to date.
• Collaborate with (cross)functional departments to resolve issues related to batch review/release, investigations, and receipt of QC test results to allow for timely release of final product batches according to department and business plan.
• Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the batch review/release process.
• Contribute to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines.
• Perform duties under limited supervision and according to standard operating and manufacturing procedures.
• Perform tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Maintain quality practices in accordance with state and federal regulatory requirements.
• Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
• Ensure readiness of records for regulatory inspections and internal audits.
• Review, compile, and organize batch data.
• Review, compile, batch documents for retention and archival.
• Ability to utilize multiple electronic quality systems.