Role Overview

This exempt-level position is responsible for performing a wide range of activities to support the Manufacturing and 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

• Review documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).
• Review documentation for miscellaneous activities executed in accordance with Good Documentation Practices (GDP).
• Work in a team based, cross-functional environment to complete tasks required to meet all business objectives.
• Perform regular administrative duties to maintain all manufacturing record which will involve binding and archiving and storage.
• Support Investigations team by providing quality and compliance input for continuous improvement and remediations; also, support or facilitate investigations for Product Quality Complaints.
• Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the batch review/ release process.
• Contribute to process improvement.
• Ensure turnaround times are adhered to during review and disposition of the Drug Product deadlines.
• Perform duties/tasks under minimal direction/supervision according to standard operating and manufacturing procedures and demonstrate ability to attain resources and information from established internal contacts.
• Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.
• Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
• Ensure readiness of manufacturing records for regulatory inspections and internal audits.
• Support of regulatory audits including preparation of documents, presentation to health authorities, and to lead actions in response to potential findings.
• Ability to utilize multiple electronic quality systems and SAP.
• Contribute to the improvement of QA practices to ensure accurate documentation activities, including manual and electronic practices.
• 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 in a complex fast paced supply chain organization.
• Contribute to cross-functional projects with stakeholders to establish best practices that will reassure the target turnaround time of a CAR-T product.

Requirements

• Bachelor's degree required in Life Sciences or Engineering.
• Minimum of 4+ years' experience in Quality Assurance Biotech/Pharmaceutical 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 diligence 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 to work 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 collaborative approach in the daily execution of procedures.
• Promote and work within a one 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 fractions, and decimals.
• Read and interpret documents such as safety rules, operating instructions and logbooks.
• Review and provide feedback for SOPs.

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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.