Full-Time

QC Investigations Specialist II

Confirmed live in the last 24 hours

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops and commercializes cell therapies

Biotechnology
Healthcare

Mid

Bridgewater Township, NJ, USA

Position requires onsite presence.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • Minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required
  • Minimum of 4 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
  • Minimum of 2 years of Quality Control experience is required.
  • Minimum of 2 years of experience with leading investigations is required.
  • Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is a plus.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
  • 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 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.
  • This position may require occasional travel to partner sites in NJ or PA as business demands.
  • This position may require up to 10% domestic or international travel as business demands.
Responsibilities
  • Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.
  • Review/complete routine CAR-T manufacturing nonconformance/deviation investigations.
  • Proactively work with stakeholders to implement effective CAPAs and to ensure the timely completion of corrective and preventive actions within the laboratories.
  • Provide recommendations for the improvement of processes by working cross functionally with multiple stakeholders.
  • Work closely with management to propose/execute improvements through the change management system.
  • Ability to respond with a high degree of urgency to departmental and cross functional needs and requests.
  • 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.

Legend Biotech develops and commercializes cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's cells to combat cancer. Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments.

Company Stage

IPO

Total Funding

$146.4M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

15%

1 year growth

40%

2 year growth

102%
Simplify Jobs

Simplify's Take

What believers are saying

  • CARVYKTI® received FDA and European Commission approval for expanded use in multiple myeloma.
  • Legend Biotech is expanding R&D with a new facility in Philadelphia.
  • The global cell therapy market is projected to grow significantly, benefiting Legend Biotech.

What critics are saying

  • Increased competition from Amgen's bispecific T-cell engager, Imdelltra.
  • Potential delays in establishing the new R&D facility in Philadelphia.
  • Technological integration challenges in collaboration with Multiply Labs.

What makes Legend Biotech unique

  • Legend Biotech focuses on personalized cell therapies for hard-to-treat cancers.
  • The company is technology agnostic, exploring multiple platforms for effective treatments.
  • Legend Biotech's CARVYKTI® is the first BCMA-targeted CAR-T therapy approved for second-line treatment.

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