QC Investigations Supervisor
Posted on 3/29/2024
Legend Biotech

1,001-5,000 employees

Develops and manufactures novel cell therapies globally
Company Overview
Legend Biotech, a global biotechnology company, stands out due to its comprehensive approach to cell therapy, extending from discovery to commercialization, and its commitment to treating intractable and incurable diseases. The company's leadership boasts significant expertise from major pharmaceutical companies, and it offers a variety of career opportunities that contribute to the development of novel therapies. With facilities in the United States, China, and Belgium, Legend Biotech is dedicated to utilizing four different technologies to target hematologic malignancies and solid tumors, demonstrating its adaptability and commitment to personalized medicine.
Biotechnology

Company Stage

N/A

Total Funding

$750.5M

Founded

2014

Headquarters

Franklin Township, New Jersey

Growth & Insights
Headcount

6 month growth

20%

1 year growth

54%

2 year growth

130%
Locations
Bridgewater Township, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • Bachelor’s Degree in Science, Engineering or equivalent technical discipline
  • Minimum of 4 years relevant work experience
  • Experience in a Quality Control setting
  • Experience with aseptic processing in ISO 5 clean room and biosafety cabinets
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products
  • Knowledge of Good Tissue Practices
  • Detailed knowledge of CAR-T QC test methods and related equipment
  • Excellent written and oral communication skill
  • Ability to accommodate shift schedule and unplanned overtime
  • Highly organized and capable of working in a team environment
  • Comfortable with speaking and interacting with inspectors
Responsibilities
  • Interview personnel within QC and provide quality insight to complete laboratory investigation reports
  • Review/complete routine CAR-T manufacturing nonconformance/deviation investigations
  • Proactively work with stakeholders to implement effective CAPAs
  • Provide recommendations for the improvement of processes
  • Work closely with management to propose/execute improvements through the change management system
  • Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA)
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
  • Work in a collaborative team setting with quality counterparts
  • Perform duties requiring exposure to and handling of biological materials and hazardous chemicals