QA Investigations Lead III at Legend Biotech

Raritan, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline
A minimum of 4 years relevant work experience (preferable in aseptic manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy)
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of 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, and experience with team-based collaborations
Ability to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk
Strong leadership skills and ability to effectively develop others
Ability to collaborate well with stakeholders, customers and peers
Strong decision-making ability and think creatively while maintaining compliance and quality
Ability to discern the criticality of issues and communicate to management regarding complex issues
Ability to manage conflict and issues that arise with internal or external customers

Responsibilities

Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues
Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints
Review and approve manufacturing procedures
Support regulatory inspections and audits by ensuring inspection readiness within facility
Perform internal housekeeping audits
Perform analysis on quality indicating data and identifying trends
Provide oversight for trending of quality compliance metrics
Provide quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment
Support and approve manufacturing investigations
Ownership of various department projects
Tracking of quality metrics while ensuring high quality and compliant product supply
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals
Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning

Skills

cGMP

GMP

CAPA

Change Control

Manufacturing Investigations

Quality Assurance

Regulatory Inspections

Audits

Cell Therapy

Quality Metrics

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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