QA Change Control Specialist II 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, Cell Therapy, PharmaceuticalIndustries

Requirements

A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline
Minimum of 2 years relevant work experience (preferable in cGMP manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy)
GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA)
Operational experience with electronic quality systems
Familiarity with core Quality Management System processes
Strong written and verbal communication skills, analytical problem solving, and conflict resolution skills
IT system lifecycle knowledge including requirements gathering, change management, implementation and continuous support (a plus)
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 environment
Effective interpersonal skills with the ability to communicate across all levels of the organization
Ability to work independently with a high degree of accountability
Proficient knowledge of Microsoft Office
Experience in quality metrics reporting

Responsibilities

Support and streamline the site change control process
Participate in change control process from initiation through completion
Schedule and participate in the site change control review board meetings
Manage change control metrics reporting
Collaborate with functional departments to resolve issues
Support drafting of standard operating procedures
Support cross-functional projects with many stakeholders
Participate in the training program for new members
Perform tasks consistent with safety policies, quality systems, and cGMP requirements
Review change controls, SOPs, and other documentation
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
Drive continuous improvement
Have advanced computer skills to increase department productivity and broaden technical and scientific knowledge
Work in a collaborative team setting with quality counterparts including Manufacturing Operations, Quality Control, and Operations Technical Support

Skills

Change Control

GMP

Quality Assurance

SOP Drafting

Metrics Reporting

Cross-Functional Collaboration

Review Board

Training

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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