Full-Time

QA Lab Oversight Specialist II

Posted on 5/17/2024

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops cell therapies for cancer treatment

Biotechnology

Mid

Bridgewater Township, NJ, USA

Required Skills
Quality Assurance (QA)
Requirements
  • A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline
  • Minimum of 4 years relevant work experience
  • Knowledge of cGMP regulations and FDA/EU guidance
  • Experience in supporting cell-based products and Good Tissue Practices
  • Strong interpersonal and communication skills
  • Proficient in process excellence tools
  • Highly organized and capable of working in a team environment
  • Good written and verbal communication skills
  • Detailed knowledge of cGMP and Good Tissue Practices
  • Experience with cell and gene therapy analytical techniques
Responsibilities
  • Provide quality oversight for site Quality Control laboratories
  • Review and approve standard operating procedures
  • Support transfer of QC Lab functions to cGMP facility
  • Review and approve Validation/Qualification/Method Transfer protocols
  • Perform spot-checks in QC Laboratories for compliance
  • Support release of patient sample materials documentation
  • Recognize and resolve quality issues
  • Act as liaison for quality team in improvement projects
  • Be a Subject Matter Expert on quality assurance topics
  • Perform other assigned duties as necessary

Legend Biotech specializes in developing and manufacturing novel cell therapies for hematologic malignancies and solid tumors, leveraging cutting-edge technologies to deliver advanced treatment options for patients worldwide. The company's pipeline of cell therapies includes agents targeting diseases considered intractable and incurable, with a focus on transforming the world of oncology and medicine.

Company Stage

IPO

Total Funding

$750.5M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

21%

1 year growth

50%

2 year growth

137%