BE: CAR-T Operations Support Supervisor at Legend Biotech

Ghent, Flanders, Belgium

Legend Biotech Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, BiopharmaIndustries

Requirements

  • Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy, or a related field
  • Minimum of 1 year in a cGMP or ATMP environment in the biotech/biopharma industry
  • Minimum of 5 years of direct people management experience overseeing teams of 10+ individuals
  • Fluent in English and Dutch

Responsibilities

  • Act as SME for quality aspects related to production activities, ensuring compliance with cGMP regulations and documentation requirements
  • Manage and review documentation in Production zones, including batch records, work instructions, SOPs, and quality-related records
  • Lead and coordinate production support activities, optimizing schedules for efficiency and compliance
  • Support Tech Transfer plans for new production introductions and process optimizations
  • Contribute to the development of manufacturing processes, training, and continuous improvement initiatives
  • Supervise and coordinate personnel, assigning daily production tasks and ensuring operational readiness
  • Implement and lead Tier 1 and Tier 2 meetings to ensure clear communication and task execution
  • Support internal and external audit readiness, representing Support Production in quality matters
  • Ensure safe and compliant operations according to EHS and cGMP standards

Skills

cGMP
CAR-T
Cryopreservation
SOPs
Batch Records
Tech Transfer
People Management
Quality Compliance
Sterilization
Material Transfer
Audit Readiness

Legend Biotech

Develops and commercializes cell therapies

About Legend Biotech

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.

Franklin Township, New JerseyHeadquarters
2014Year Founded
$146.4MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
1,001-5,000Employees

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Paid Sick Leave
Paid Holidays
Remote Work Options

Risks

Increased competition from Amgen's Imdelltra may impact CAR-T therapy focus.
Collaboration with Multiply Labs may face technological challenges, delaying production timelines.
Financial strain from new R&D facility could affect operational focus if advancements lag.

Differentiation

Legend Biotech focuses on novel cell therapies for oncology, including CAR-T and NK cells.
The company is technology agnostic, exploring multiple platforms for effective cancer treatments.
Legend Biotech's CARVYKTI® is the first BCMA-targeted CAR-T therapy approved for second-line use.

Upsides

Recent FDA and European approvals for CARVYKTI® expand its market reach in multiple myeloma.
New R&D facility in Philadelphia boosts innovation in next-generation cell therapies.
Alan Bash's appointment could accelerate CARVYKTI®'s growth and market penetration.

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