QA Shop Floor Specialist 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

Bachelors degree required in Life Sciences or Engineering
0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience
Relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy
Experience with quality support in clinical manufacture is preferred
Flexible to work on weekends, as needed
Mobile and able to independently transport themselves between various sites/locations
Frequently required to communicate with coworkers
Regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms
Ability to lift 20 lbs
Report to work on-time
Duties required to be performed on-site at manufacturing facility
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
Practice good interpersonal and communication skills
Demonstrate positive team-oriented approach in the daily execution of procedures
Promote and work within a team environment
Learn new skills, procedures and processes as assigned by management and continue to develop professionally

Responsibilities

Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process
Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/internal audits
Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing issues
Real time review of all documentation, and reporting, in support of process unit operations, in accordance with Good Documentation Practices (GDP)
Review, revise, or draft Standard Operating Procedures (SOPs)
Support on process aseptic process simulations of the processes to ensure sterility of the product/process is not compromised
Support material release in SAP for In-house reagents
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
Aseptically gown / practice aseptic behavior in controlled areas
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
Exposure to and handling of biological materials and hazardous chemicals
Attend departmental and other scheduled meetings
Perform other duties as assigned

Skills

cGMP

GDP

SOP

SAP

Aseptic Gowning

Internal Audits

Batch Records

Quality Oversight

Electronic Quality Systems

Cell Therapy Manufacturing

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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