Sr. Advanced Analyst, Clinical QC Operations and Sciences

Legend Biotech US-posted 4 months ago
$107,482 - $141,070/Yr
Full-time • Mid Level
Somerset, NJ
1,001-5,000 employees
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Legend Biotech is seeking Sr. Advanced Analyst, Clinical QC Operations and Sciences as part of the Technical Development team based in Somerset, NJ. The Sr. Advanced Analyst, Clinical QC Operations and Sciences will be responsible for providing technical strategies and performing related activities necessary to start up and perform routine operations within a new in-house GMP facility and deliver Phase 1 clinical trial material for several cell and gene therapy pipeline assets to patients in need. The successful candidate will collaborate with a cross-functional team including development, quality, IT, facilities, safety, and operations to establish the systems necessary to operate quality control laboratory for the purpose of producing Phase 1 products. The following activities will include implementing testing and release for cell and gene therapy product candidates. Additionally, the successful candidate will lead quality control testing, complex investigations, and coordinate with external parties for testing.

  • 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.
  • 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.
  • Medical, dental, and vision insurance.
  • 401(k)-retirement plan with company match that vest fully on day one.
  • Equity and stock options 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.
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