Supervisor
QC Micro
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
Environmental Sciences
Life Sciences
Requirements
  • Bachelor’s Degree in Science, Engineering or equivalent technical discipline
  • Minimum of 2 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
  • Knowledge of Good Tissue Practices
  • Detailed knowledge of routine and non-routine testing and sampling methods
  • Detailed knowledge of the shop floor manufacturing process
  • Comprehensive knowledge of trending using statistical analysis
  • Ability to pay attention to details and follow procedures
  • Excellent written and oral communication skills
  • 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
  • Occasional travel to partner sites in NJ or PA
  • Up to 10% domestic or international travel
Responsibilities
  • Performing routine Environmental Monitoring sampling
  • Working with Process Development team, Quality and Operations organization
  • Creating, reviewing, and approving relevant QC documents, SOP’s and WI’s
  • Ensuring microbiological control strategy is consistent with cGMP requirements
  • Participating in training and delivery of Operations aseptic technique and microbiology awareness training program
  • Maintaining, re-evaluating, and communicating key critical inputs to site environmental monitoring program
  • Performing peer review/approval of laboratory data
  • Utilizing electronic systems (LIMS) for execution and documentation of testing
  • Performing tasks in a manner consistent with safety policies, quality systems, and cGMP requirements
  • Accommodating shift schedule and unplanned overtime
  • Working in a team environment with a positive attitude under some supervision
  • Occasional travel to partner sites in NJ or PA
  • Up to 10% domestic or international travel