QA Validation Specialist III at Legend Biotech

Raritan, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Cell Therapy, PharmaceuticalIndustries

Requirements

A minimum of 4 years relevant work experience (preferable in an aseptic manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy)
Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals (experience in supporting cell-based products is a plus)
Strong knowledge of GxP compliance
Experience in cGMP regulatory body audits

Responsibilities

Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the site
Review and approve qualification/validation documentation (specifications, protocols, reports)
Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration)
Provide expertise and solutions to issues regarding qualification and validation strategies and documentation
Provide guidance on industry best practices and quality requirements for maintaining a compliant state for all site systems
Assist in the development of validation and qualification related policies, procedures, templates, forms
Provide quality oversight on data integrity of systems, instruments, and equipment used at the site
Develop and evaluate quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations
Interact with colleagues in Quality and Technical Services proactively to assess and guide in the deployment of systems at the CAR-T Raritan Site
Review and approve change controls, SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ensure effectiveness of related actions
Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements
Drive continuous improvement
Other duties may be assigned, as necessary

Skills

GMP

Validation

Qualification

Computer Systems Validation

Equipment Qualification

Process Validation

Risk Assessment

Data Integrity

Quality Oversight

Technical Review

Protocol Approval

Report Approval

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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