QC Data Reviewer II
Posted on 3/22/2024
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

18%

1 year growth

54%

2 year growth

130%
Locations
Bridgewater Township, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
CategoriesNew
Lab & Research
Life Sciences
Requirements
  • Bachelor’s degree in science, Engineering or equivalent technical discipline
  • Minimum of 1-year relevant work experience, preferably within a biological and/or pharmaceutical industry
  • Experience in a Quality Control setting is preferred
  • Knowledge of cGMP and GDP regulations and FDA/EU guidance related to manufacturing of cell-based products
  • Detailed knowledge of CAR-T QC test methods and related equipment is preferred
  • Excellent written and oral communication skill are required
  • Candidates must be able to accommodate shift schedule
  • Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision
  • Comfortable with speaking and interacting with inspectors
  • Due to the nature of the Data Review process, this role is 100% onsite at the Raritan, NJ location
Responsibilities
  • Perform peer review/approval of laboratory data
  • Utilization of electronic systems (LIMS) for execution and documentation
  • Create, review, and approve relevant QC documents, SOP’s and WI’s
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
  • Immediately alerts supervisor/manager when data discrepancies are identified
  • Job duties performed may occasionally require exposure to and handling of biological materials and hazardous chemicals