Quality Person In Plant at Legend Biotech

Ghent, Flanders, Belgium

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalIndustries

Requirements

Bachelor’s Degree in Science, Engineering or equivalent technical discipline, or relevant years of experience within the pharmaceutical industry
Minimum of 2 years relevant work experience (preferable: aseptic manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy; minimum 2 years quality support in clinical manufacture preferred)
Experience with aseptic processing in ISO 5 clean room and biosafety cabinets
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products, as well as Good Tissue Practices
Great attention to detail and ability to follow procedures
Highly organized and capable of working in a team environment with a positive attitude under minimal supervision
Good written and verbal communication skills
Ability to summarize and present results, with experience in team-based collaborations
Ability to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk
Strong leadership skills

Responsibilities

Serves as a Quality person in plant in support of cell therapy manufacturing
Ensures Quality Oversight in plant covering various process related activities
Performs periodic Quality checks/audits related to process, documentation and process manipulations
Strive to reduce non-conformances and deviations in supported areas by proactively driving compliance
Responsible for real time review of process documentation in support of process unit operations and release activities where needed
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues
Supports in accurate and timely input, investigation and review of manufacturing deviations, CAPAs, change controls and complaints
Review and approve manufacturing procedures and batch records
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
Support regulatory inspections and audits by ensuring inspection readiness within facility
Perform internal housekeeping audits
Other duties will be assigned, as necessary

Skills

Key technologies and capabilities for this role

GMPcGMPCAPAChange ControlBatch Record ReviewAseptic ManufacturingQuality AuditingDeviation InvestigationRegulatory InspectionsInternal Audits

Questions & Answers

Common questions about this position

Is this position remote or onsite?

This is an onsite position performed within a team according to an assigned production shift schedule.

What education and experience are required for this role?

A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required, along with at least 2 years of relevant work experience, preferably in aseptic manufacturing, quality assurance, or cell therapy.

What are the top skills needed for the Quality Person In Plant role?

Key skills include aseptic processing in ISO 5 clean rooms, knowledge of cGMP regulations and FDA/EU guidance for cell-based products, great attention to detail, strong communication skills, and the ability to work in a team under minimal supervision.

What is the work schedule like for this position?

The role works in shift regimes supporting 7/7 days cell processing according to an assigned production shift schedule.

What makes a strong candidate for this Quality Person In Plant position?

Strong candidates have experience in aseptic manufacturing facilities, particularly in quality assurance or cell therapy, along with leadership skills, problem-solving abilities to ensure compliance, and a positive team-oriented attitude.

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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