Legend Biotech · 1 day ago
Associate Manager, QC
Raritan, NJ
Full-time
Onsite
Senior Level, Lead/Staff
$93K/yr - $123K/yr
8+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases, headquartered in Somerset, New Jersey. They are seeking an Associate Manager, QC to manage the operation and workflow of the quality control laboratories in support of cell therapy manufacturing, including staff management and laboratory oversight.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Ensuring adequate training (skills-based, cGMP and safety) of associates within the department
Oversight of raw material, in-process, environmental/utility, product release, and stability testing, investigation of laboratory non-conformances (events, deviations, and invalid assays), and maintenance, calibration and qualification of laboratory instruments and equipment
Support test method verification, qualification, validation and/or transfer activities in the QC laboratories in conjunction with QC Management and QA Validation/Equipment groups
Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations. Make quick, informed decisions with minimal to no supervision during 2nd shift hours
Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements
Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
Other duties will be assigned, as necessary
Authority to make decisions related to day-to-day processing of batches in the QC laboratory. Decisions must be made in conjunction with the Quality Assurance team if an issue is not addressed by any Legend Biotech Standard Operating Procedure. Decisions related to project execution, including timelines, milestones and resource allocation within budget can be made in collaboration with QC Leadership. Higher-level approvals are required for those related to significant budget allocations, strategic shifts, or major collaborations that have substantial financial or long-term implications
Qualification
Required
A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required
A minimum of 8 to 10 years of relevant work experience is required
A minimum of 2 to 4 years of direct people leadership experience is REQUIRED
Required shift hours will be Monday-Friday, 5PM-1:30AM
People management or leadership experience is required
Experience working with Quality systems is required
Extensive knowledge of chemical, biochemical and microbiological concepts is required
Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required
Knowledge of cGMP regulations and FDA/EU guidance is required
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal to no supervision
Comfortable with speaking to and interacting with inspectors and supporting additional regulatory audit activities as needed
Good written and verbal communication skills are required
Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
Preferred
Experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell therapy
Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development
Experience with quality support in clinical manufacturing or NPI
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 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
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
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
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
thefly.com
2025-12-09
Company data provided by crunchbase