QC Specialist, Lab Services, II/III 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 or higher
A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry
A degree in Biology, Biochemistry, Microbiology, Chemistry or related field
Solid understanding of regulatory requirements, policies and guidelines
Experience with Quality Control document reviews and regulatory inspection processes
Working knowledge of Quality systems
Experience in management of retain samples using electronic systems (eLIMS)
Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process
This position will be located in Raritan, NJ and may require up to 5% of travel
This position will occasionally require to lift up to 20 pounds

Responsibilities

Prepares and reviews documentation independently
Responsible for QC sample and retain management
Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS)
Prepare documents and coordinate Sample shipment (internal and external shipments)
Review logbooks and/ or LIMs to align physical quantities of samples in freezers/refrigerators
Periodic inspection and consolidation of retains
Document and perform sample management related non-conformance investigations
Document and handle corrective and preventative action records
Supports internal and regulatory audits

Skills

cGMP

LIMS

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Microsoft Outlook

Sample Management

Documentation Review

Quality Control

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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