Operations Gowning Trainer

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.

About the role

This position is responsible for performing manufacturing gowning training and the execution of gowning training tasks within a CGMP environment. The role ensures quality and maintains the highest standards in compliance with company policies, procedures, and all applicable regulations.

Responsibilities

• Support the Gowning Training Program responsible for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
• Execute Instructor Led Trainings (ILT), Qualifications, and Requalification of Raritan CAR-T Personnel.
• Execute manufacturing gowning activities to support cell culturing, purification, aseptic processing, and cryopreservation using appropriate gowning techniques.
• Perform gowning training and execution that follows 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, cGMP, and Learning Management System (LMS) requirements.
• Work in a team-based, cross-functional environment to complete production tasks required by shift schedule.
• Aid in the development of manufacturing gowning processes including appropriate documentation.
• Drive continuous improvement of gowning techniques and processes leveraging own observation as well as input of team members.
• Support schedule adjustments to meet production and business needs.
• Accurately complete documentation in SOPs, logbooks, GMP documents, and training events.
• 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 qualifications and training.
• Support the ongoing production schedule by:
  • Reporting to work on-time and according to the shift schedule.
  • Performing other duties as assigned.
  • Attending departmental and other scheduled meetings.
• Practice good interpersonal and communication skills.
• Demonstrate a 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 4-6 years of Biotech/Pharmaceutical experience or equivalent industry experience OR Bachelor’s degree in Life Sciences or Engineering, with 0-2 years of Biotech/Pharmaceutical experience or equivalent industry experience.
• Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Follow instructions and solve practical problems with concrete variables in situations where only limited standardization exists.
• Perform basic arithmetic operations: addition, subtraction, multiplication, and division 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.
• Solid knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.
• Mobility to independently transport between various sites/locations as required.
• Frequent communication with coworkers.
• Regularly required to stand, walk, climb, bend, stop, and reach with hands and arms.
• Ability to lift 25 lbs.
• Perform gowning procedures to work in a manufacturing core.

Pay

Base pay range: $59,168 - $77,658 USD. Other types of pay include performance-based bonus and/or equity for eligible roles.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off policy including vacation time, personal time, sick time, floating holidays, and eleven company holidays.
• Voluntary benefits:
  • Flexible spending and health savings accounts.
  • Life and AD&D insurance.
  • Short- and long-term disability coverage.
  • Legal assistance.
  • Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
  • Voluntary commuter benefits.
  • Family planning and care resources.
  • Well-being initiatives.
  • Peer-to-peer recognition programs.