QC Analyst I at Legend Biotech

Raritan, New Jersey, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s Degree in Science, Engineering or equivalent technical discipline
Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry
Experience in a Quality Control setting (preferred)
Experience with processing samples in biosafety cabinets utilizing aseptic technique (strongly preferred)
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products (strongly preferred)
Knowledge of Good Tissue Practices
Knowledge of CAR-T QC test methods and related equipment (preferred)
Excellent written and oral communication skills
Ability to accommodate shift schedule, including routine weekend and evening work
Ability to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
Highly organized and capable of working in a team environment with a positive attitude under some supervision
Comfortable with speaking and interacting with regulatory inspectors
Occasional travel to partner sites in NJ or PA as business demands (up to 5% domestic or international travel)
Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities
Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive
Works effectively in the face of ambiguity, shifting priorities

Responsibilities

Completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment
Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations
Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories
Perform peer review/approval of laboratory data
Utilize electronic systems (LIMS) for execution and documentation of testing
Create, review and approve relevant QC documents, SOP’s and WI’s
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development
Routine exposure to and handling of biological materials and hazardous chemicals

Skills

cGMP

GMP

LIMS

SOP

Analytical Testing

QC Testing

Peer Review

CAR-T

Cell Therapy

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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