Full-Time
QC Investigations Supervisor
Posted on 3/29/2024
Develops cell therapies for cancer treatment
Mid
Bridgewater Township, NJ, USA
- 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
- 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
Legend Biotech, a leader in cell therapy for cancer treatment, appeals as an excellent workplace due to its significant role in crafting advanced solutions for hematologic malignancies and solid tumors. The company not only prides itself on a pioneering spirit in the challenging field of oncology but also fosters an environment where innovation and commitment to patient-centric breakthroughs are deeply ingrained in its culture. Working here offers the unique opportunity to be at the forefront of transforming cancer treatment, surrounded by driven professionals dedicated to making a real-world impact.
Company Stage
IPO
Total Funding
$750.5M
Headquarters
Franklin Township, New Jersey
Founded
2014