Legend Biotech · 2 months ago
Sr. Advanced Analyst, Clinical Manufacturing Operations and Sciences
Somerset, New Jersey, United States
Full-time
Onsite
Mid, Senior Level
$107K/yr - $141K/yr
5+ years expLegend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. The Sr. Advanced Analyst will be responsible for providing technical strategies and performing activities necessary to operate a new in-house GMP facility and deliver Phase 1 clinical trial material for cell and gene therapy assets.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Create and author laboratory test methods and additional procedures necessary to operate a quality control laboratory at Phase 1 clinical standards
Work cross-functionally with analytical development to perform method transfers and qualifications within the quality control laboratory
Review and approve quality control test results, ensuring data integrity and compliance with cGMP and regulatory requirements
Troubleshoot assay performance issues and support method optimization and development
Schedule and execute routine testing of cell and gene therapy products in collaboration with related functions including development, quality, IT, facilities, safety, and operations
Perform complex laboratory investigations including OOS, OOT, and deviations
Author and review investigation reports, CAPAs, and change controls
Drive continuous improvement initiatives to reduce error rates
Represent QC in cross-functional meetings and project teams, providing subject matter expertise on analytical methods and regulatory expectations
Coordinate with contract testing labs (CTL) to send samples for external testing and investigate out-of-specification results collaboratively with CTL
Maintain the QC laboratory per internal procedures
Train QC analysts on GMP and laboratory best practices
Foster a culture of quality and compliance
Qualification
Required
BS in cell biology, molecular biology, immunology, microbiology, biomedical engineering or other related sciences preferred
5+ years of experience in cell and gene therapy GMP quality control testing including operations, supervision, and strategy setting
Knowledge and experience with cell and gene therapy manufacturing quality control tests
Familiarity with viral vector manufacturing quality control tests
Experience establishing and operating in a GMP environment
Familiarity with cell and gene therapy testing instruments
Pragmatism in applying GMP in a phase-specific manner in the best interest of the patient
Experience working in cross-functional matrices
Excellent collaboration skills
Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment
Familiarity with aseptic processing
Patient focus is a must
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.
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