Quality Systems Lead at Legend Biotech

Raritan, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline or relevant experience
A minimum of 4 years relevant work experience (preferable experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy)
GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR parts 210, 211, 1271, 600, 601, 610, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA)
Strong written and verbal communication, analytical problem solving and conflict resolution skills
Flexible, highly motivated, with strong organization skills, ability to multitask with attention to detail
Ability to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment
Flexibility in work schedule
Effective interpersonal skills with the ability to communicate across all levels of the organization
Ability to work independently with a high degree of accountability
Ability to quickly process complex information
Proficient in applying process excellence tools and methodologies
Ability to independently be responsible for a portfolio of ongoing projects
Ability to work with and lead others in a team environment
Experience developing and setting long-term objectives
Ability to identify/remediate gaps in processes
Operational experience with electronic quality systems
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

Responsibilities

Provide oversight to the CAPA program for the CAR-T manufacturing site
Oversee metrics, trending, and reporting of relevant quality systems records
Support CAPA site governance program
Drive continuous improvement of quality systems processes
Ensure compliance with current Good Manufacturing Practices (cGMP)
Manage multiple and complex cross-functional projects with many stakeholders
Support other quality systems activities, as needed
Support drafting, review and approval of standard operating procedures and any other required documentation
Collaborate with functional departments to resolve issues
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
Require minimal direction to complete tasks, know how to get resources and information from established internal contacts, and consult with supervisor for decisions outside established processes

Skills

CAPA

cGMP

GxP

Quality Systems

Aseptic Manufacturing

Cell Therapy

CAR-T

SOP

Metrics Trending

Cross-Functional Projects

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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