Operations Associate, 1st Shift

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. 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.

Legend Biotech is seeking an Operations Associate as part of the Technical Operations team based in Raritan, NJ
.

Role Overview

This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Key Responsibilities

• Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
• Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
• Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
• Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).
• Perform tasks on time in a manner consistent with quality systems and cGMP requirements.
• Work in a team-based, cross-functional environment to complete production tasks required by shift schedule.
• Aid in the development of manufacturing processes including appropriate documentation.
• Drive continuous improvement of manufacturing operations leveraging own observation as well as input of team members.
• Handle human-derived materials in containment areas.
• Support schedule adjustments to meet production.
• Accurately complete documentation in SOP’s, logbooks, and other GMP documents.
• Demonstrate training progression through assigned curriculum.
• Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.
• Wear the appropriate PPE when working in manufacturing and other hazardous working environments.
• Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
• Ensure materials are available for production.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.

Requirements

• HS Diploma required with 3-5 Years Biotech/Pharmaceutical experience or equivalent industry experience.
• Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Follow instructions.
• 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.
• Knowledge and ability to operate manufacturing, manufacturing-support, and lab equipment.
• Knowledge of Process Excellence Tools.
• Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.

EEO Statement

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.