CAR-T Operations Supervisor at Legend Biotech

Ghent, Flanders, Belgium

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalIndustries

Requirements

Bachelor’s or Master’s degree in science, bioengineering, pharmacy, or a related field, or equivalent experience
At least 5 years of experience in a cGMP or ATMP environment, preferably in the biotech or pharmaceutical industry
Fluent Dutch and English (written and spoken)
Familiarity with Microsoft Office tools (Word, Excel, PowerPoint, Outlook). Familiarity with Manufacturing Execution Systems (MES) and Electronic Batch Record (EBR) systems is a plus

Responsibilities

Manage operational teams and supervise various operational units within the CAR-T production process
Manage all aspects of quality and ensure strict compliance with cGMP standards. Serve as a domain expert for Quality and Operations, playing a central role in GMP inspections
Be the first point of contact for production problems and work closely with other departments to find solutions
Manage and review critical documentation within the production areas, such as procedures, work instructions, logs, and transfer forms
Oversee the release and review of batch records for quality control
Ensure that all team members receive the necessary training to perform at their best
Initiate projects to increase efficiency, reduce costs, and improve quality. Encourage and inspire the team to continuously improve

Skills

Key technologies and capabilities for this role

cGMPATMPCAR-T productionMicrosoft ExcelMicrosoft WordMicrosoft PowerPointMESEBRGMP inspectionsBatch Record ReviewQuality Compliance

Questions & Answers

Common questions about this position

What is the salary for the CAR-T Operations Supervisor position?

This information is not specified in the job description.

Is this role remote or onsite, and what's the work schedule?

The position is onsite at the manufacturing facility in Ghent with a work schedule of 4 days on followed by 4 days off.

What are the key requirements and skills for this role?

Candidates need a Bachelor’s or Master’s in science, bioengineering, pharmacy or related, at least 5 years in cGMP or ATMP environments preferably in biotech/pharma, fluent Dutch and English, and familiarity with Microsoft Office; MES and EBR systems are a plus.

What is the company culture like at Legend Biotech?

The company offers a supportive and innovative work environment that values and encourages learning and personal development.

What makes a strong candidate for the CAR-T Operations Supervisor role?

A strong candidate has 5+ years in cGMP/ATMP biotech/pharma settings, leadership experience in operations, expertise in quality compliance and GMP inspections, plus fluency in Dutch and English.

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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