C&Q Support Technician at Legend Biotech

Ghent, Flanders, Belgium

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Graduate or Bachelor’s Degree in Science, Engineering, Bioengineering or equivalent technical discipline (preferred)
Minimum of 1 year experience within a regulated environment (preferred)
Proficient user of Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
Right-first-time mindset
Ability to work independently, prioritize and manage multiple tasks simultaneously, and balance competing priorities effectively
Flexible mindset to guarantee business continuity
Clear verbal and written communication skills
Ability to pay attention to details and follow procedures
Highly organized
General GMP mindset and strong ability to autonomously organize, execute, and document administrative tasks
Languages: Dutch, English

Responsibilities

Organize and execute day-to-day administrator activities in cleanrooms on computerized systems, including adding/removing users, extracting audit trails, periodic deleting of files, making back-ups, and corresponding documentation according to Good Documentation Practices
Make run data exports to a centralized location upon operational request
Keep oversight of all user access requests and maintain corresponding mailbox
Keep oversight on segregation of duties when following up on user access requests
Follow-up on archival of user access request forms
Support paper and digital archival of executed C&Q documentation and track oversight
Support in collecting prerequisite documentation needed for execution of C&Q and periodic review activities
Handle day-to-day administrator activities for CAR-T Ghent facilities, including managing users, extracting audit trails, periodic deleting of files, and making back-ups on computerized GMP systems

Skills

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Microsoft Outlook

GMP

cGMP

Audit Trail Extraction

User Access Management

Data Backup

Good Documentation Practices

CAR-T Manufacturing

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.

Land your dream remote job 3x faster with AI

Try Jobo Free