QA Shop Floor 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, PharmaceuticalsIndustries

Requirements

Bachelors degree required
Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses
Color Perception both eyes 5 slides out of 8
Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas

Responsibilities

Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process
Support manufacturing activities for cGMP compliance through spot checks/internal audits
Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues
Review of all documentation, in accordance with Good Documentation Practices (GDP)
Review, revise, or draft Standard Operating Procedures (SOPs)
Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised
Support batch review & material release in SAP for In-house reagents
Support Floor Spot-check, audit trail review
Strive to reduce non-conformances in supported areas by proactively driving compliance
Support Investigations team by providing quality and compliance input for continuous improvement and remediations
Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor
Utilize multiple electronic quality systems, batch records and SAP
Work in a team based, cross-functional environment to complete tasks required to meet business objectives
Provide QA shop floor support for extended periods of time
Support regulatory inspections and audits as needed
Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements
Other duties will be assigned, as the need arises

Skills

cGMP

Shop Floor Oversight

CAR-T Manufacturing

Cell Therapy

Internal Audits

Good Documentation Practices

Quality Compliance

Cleanroom

Biotechnology

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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