Full-Time

QC Technical Trainer

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops and manufactures novel cell therapies globally

Biotechnology

Junior, Mid

Bridgewater Township, NJ, USA

Required Skills
Communications
Requirements
  • Bachelor's Degree in Science, Engineering or equivalent technical discipline
  • 2-4 years relevant work experience in biological and/or pharmaceutical industry
  • Quality Control setting experience
  • Experience with biosafety cabinets
  • Knowledge of cGMP regulations and FDA/EU guidance for cell-based products
  • Knowledge of Good Tissue Practices
  • Detailed knowledge of CAR-T QC test methods and related equipment
  • Excellent written and oral communication skills
  • Ability to accommodate occasional weekend and evening work
  • Highly organized and capable of working in a team environment
  • Comfortable with speaking and interacting with inspectors
  • Occasional travel to partner sites in NJ or PA
Responsibilities
  • Lead and supervise onboarded CAR-T new hires through their initial training process
  • Conduct training for QC test methods and any other QC process qualifications to QC analyst
  • Work closely with QC Leads/supervisors to ensure planned training events are completed as scheduled
  • Coordinate new hires with the completion of their trainings/qualifications
  • Support in daily completion of QC testing related to the manufacturing of autologous CAR-T products
  • Ensure testing and training is completed in compliance with all applicable procedures, standards, and GMP regulations
  • Work with Process Development team, Quality, and Operations organization to transfer process/analytical testing to cGMP facility
  • Perform peer review/approval of laboratory data
  • Build strong partnerships with Training, SMEs, and Quality Assurance to ensure seamless execution of daily training and qualification tasks
  • Support the development of training/qualification processes, participate in various department projects, and drive continuous improvements and efficiencies within cell therapy Technical Operations

Company Stage

N/A

Total Funding

$750.5M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

20%

1 year growth

58%

2 year growth

134%