QC Analyst at Legend Biotech

Ghent, Flanders, Belgium

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

Bachelor's degree in lab technologies or other related field, or equivalent experience
Practical experience in an aseptic production facility within QC or QA (plus, not required)
Strong written and oral communication skills in both Dutch and technical English
Knowledge of cGMP regulations and FDA/EU guidelines
Practical experience with aseptic processing in ISO 5 clean rooms (plus)
Familiarity with CAR-T QC testing methods (plus)
Knowledge of Good Tissue Practices (plus)

Responsibilities

Perform QC testing for CAR-T products in IPC laboratories and ensure compliance with all procedures, standards, and GMP regulations
Verify clean room classification by taking samples of (non-) viable particles and microorganisms
Work closely with the Quality and Operations departments to bring analytical testing from the test bench to production
Review and approve QC data, maintain process integrity through accurate documentation, and manage test results in eLIMS software
Create and review QC documents, SOPs, and work instructions, and contribute to process optimizations

Skills

Key technologies and capabilities for this role

cGMPGMP regulationsFDA guidelinesEU guidelinesAseptic processingISO 5 clean roomsCAR-T QC testingEnvironmental monitoringeLIMSSOPs

Questions & Answers

Common questions about this position

What is the work location and arrangement for this QC Analyst role?

The position is onsite in Ghent.

What salary and benefits are offered for this position?

An attractive salary package is offered, complemented by fringe benefits including additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, and an end-of-year and performance bonus.

What are the key requirements and skills needed for this QC Analyst position?

A Bachelor's degree in lab technologies or related field (or equivalent), strong communication in Dutch and technical English, and knowledge of cGMP regulations and FDA/EU guidelines are required. Practical experience in aseptic production, ISO 5 clean rooms, CAR-T QC testing, and Good Tissue Practices is a plus.

What is the work schedule and team environment like at Legend Biotech?

The work schedule is 4 days on followed by 4 days off in a supportive, innovative environment with a fantastic international team, fun events, and emphasis on learning and growth.

What makes a strong candidate for the QC Analyst role?

Candidates with a Bachelor's in lab technologies or equivalent, strong Dutch and technical English skills, cGMP knowledge, and plus experience in aseptic processing or CAR-T testing will stand out, especially those passionate about quality in cell therapy.

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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