Operations Associate, 1st Shift

Legend Biotech is seeking an Operations Associate, 1st Shift 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.

Shift Schedule: Wed-Sat, 1st Shift

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.
• Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.
• Color Perception both eyes 5 slides out of 8.
• Support the ongoing production schedule by:
  • Report to work on-time and according to the shift schedule.
  • 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.
  • Support investigation efforts as required.
  • Responsible for audit preparation and participation.

Requirements

• HS Diploma required with 3 – 5 Years Biotech/Pharmaceutical experience or equivalent industry experience // OR // Associates Degree required in Life Sciences or Manufacturing with 2 - 3 years of related experience // OR //Bachelors Degree required in Life Sciences with 0 - 2 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 factions, 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.
  
• 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 25 lbs.
  
• Needs to perform gowning procedures to work in manufacturing core.