Legend Biotech · 21 hours ago
QC Analyst I
Legend Biotech is a global biotechnology company dedicated to treating life-threatening diseases through advanced cell therapies. The QC Analyst I will be responsible for performing quality control testing related to the manufacturing of cell therapy products in a controlled GMP environment, ensuring compliance with procedures and standards.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Be responsible for the 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
Qualification
Required
Bachelor's Degree in Science, Engineering or equivalent technical discipline is required
Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required
Knowledge of Good Tissue Practices is required
Excellent written and oral communication skill are required
Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process
Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
The candidate must be 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
This position may require occasional travel to partner sites in NJ or PA as business demands
This position may require up to 5% domestic or international travel as business demands
Preferred
Experience in a Quality Control setting is preferred
Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred
Knowledge of CAR-T QC test methods and related equipment is preferred
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options are available to employees in eligible roles
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Recent News
legacy.thefly.com
2026-01-22
2026-01-22
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