Sr. Advanced Analyst, Clinical Manufacturing Operations and Sciences

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking Sr. Advanced Analyst, Clinical Manufacturing Operations and Sciences as part of the Technical Development team based in Somerset, NJ. 

Role Overview

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

Key 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.

Requirements

• 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
•  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

#Li-JR1

#Li-Hybrid

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.