Legend Biotech
Sr. Advanced Analyst, Clinical Manufacturing Operations and Sciences
Legend Biotech, Franklin Park, New Jersey, United States
Overview
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 CAR-T, TCR-T, and NK cell–based immunotherapy. Legend Biotech operates globally with R&D sites and collaborates to advance therapeutics for patients worldwide. Legend Biotech is seeking a Sr. Advanced Analyst, Clinical QC Operations and Sciences as part of the Technical Development team based in Somerset, NJ. Responsibilities
Create and author laboratory test methods and procedures to operate a quality control laboratory at Phase 1 clinical standards. Collaborate with analytical development to perform method transfers and qualifications within the QC laboratory. Review and approve quality control test results, ensuring data integrity and regulatory/compliance with cGMP 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 (development, quality, IT, facilities, safety, 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 with SME on analytical methods and regulatory expectations. Coordinate with contract testing labs (CTL) for external testing and investigate out-of-specification results with CTL. Maintain the QC laboratory per internal procedures; train QC analysts on GMP and lab best practices; foster a culture of quality and compliance. Qualifications
BS in cell biology, molecular biology, immunology, microbiology, biomedical engineering or related sciences preferred. 5+ years of experience in cell and gene therapy GMP QC testing including operations, supervision, and strategy setting. Knowledge/experience with cell and gene therapy manufacturing QC tests; familiarity with viral vector QC tests. Experience establishing and operating in a GMP environment; familiarity with cell and gene therapy testing instruments. Ability to apply GMP pragmatically in a phase-specific manner with patient focus; strong collaboration skills; able to manage shifting priorities in a fast-paced environment. Experience working in cross-functional matrices and aseptic processing familiarity. Compensation
Anticipated base pay range: $107,482—$141,070 USD. Benefits
Legend Biotech offers a best-in-class benefits package including medical, dental, vision, 401(k) with company match, paid parental leave, PTO, flexible spending accounts, health savings accounts, life and disability insurance, legal assistance, and additional voluntary benefits. Benefits are designed to support well-being, financial stability, and long-term career growth. EEO Statement
Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Employment is at-will and Legend may adjust compensation based on performance or market conditions. Legend Biotech maintains a drug-free workplace.
#J-18808-Ljbffr
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 CAR-T, TCR-T, and NK cell–based immunotherapy. Legend Biotech operates globally with R&D sites and collaborates to advance therapeutics for patients worldwide. Legend Biotech is seeking a Sr. Advanced Analyst, Clinical QC Operations and Sciences as part of the Technical Development team based in Somerset, NJ. Responsibilities
Create and author laboratory test methods and procedures to operate a quality control laboratory at Phase 1 clinical standards. Collaborate with analytical development to perform method transfers and qualifications within the QC laboratory. Review and approve quality control test results, ensuring data integrity and regulatory/compliance with cGMP 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 (development, quality, IT, facilities, safety, 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 with SME on analytical methods and regulatory expectations. Coordinate with contract testing labs (CTL) for external testing and investigate out-of-specification results with CTL. Maintain the QC laboratory per internal procedures; train QC analysts on GMP and lab best practices; foster a culture of quality and compliance. Qualifications
BS in cell biology, molecular biology, immunology, microbiology, biomedical engineering or related sciences preferred. 5+ years of experience in cell and gene therapy GMP QC testing including operations, supervision, and strategy setting. Knowledge/experience with cell and gene therapy manufacturing QC tests; familiarity with viral vector QC tests. Experience establishing and operating in a GMP environment; familiarity with cell and gene therapy testing instruments. Ability to apply GMP pragmatically in a phase-specific manner with patient focus; strong collaboration skills; able to manage shifting priorities in a fast-paced environment. Experience working in cross-functional matrices and aseptic processing familiarity. Compensation
Anticipated base pay range: $107,482—$141,070 USD. Benefits
Legend Biotech offers a best-in-class benefits package including medical, dental, vision, 401(k) with company match, paid parental leave, PTO, flexible spending accounts, health savings accounts, life and disability insurance, legal assistance, and additional voluntary benefits. Benefits are designed to support well-being, financial stability, and long-term career growth. EEO Statement
Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Employment is at-will and Legend may adjust compensation based on performance or market conditions. Legend Biotech maintains a drug-free workplace.
#J-18808-Ljbffr