QC Analyst III jobs in United States
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Legend Biotech · 1 day ago

QC Analyst III

Legend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. They are seeking a QC Analyst III to perform QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

BiotechnologyHealth CareLife ScienceOncologyTherapeutics
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H1B Sponsor Likelynote

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
Job duties performed require routine exposure to and handling of biological materials and hazardous chemicals

Qualification

CGMP regulationsQuality Control experienceAseptic techniqueTissue PracticesCAR-T QC test methodsWritten communicationOral communicationTeam collaborationProject management

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
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, and rapid change; maintains a positive outlook in difficult situations; a change agent
Identifies and focuses on activities of highest value and impact; makes informed decisions quickly
Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency
Considers resources, alternatives, constraints and desired outcomes to make effective decisions
Employs good project management principles to appropriately align time, resources, and budgets
Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect
Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect
Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally
Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment
Takes initiative, actively shares knowledge, builds skills, promotes new ideas and embraces change
Generates new solutions to problems by challenging the status quo and conventional thinking

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
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes vacation days, personal days, sick time, 11 company 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

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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 Company
Total Funding
$750.45M
2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO

Leadership Team

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Carlos Santos
Chief Financial Officer
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Alan Bash
President, CARVYKTI
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Company data provided by crunchbase