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Sr. Advanced Microbiologist, Clinical QC Operations and Sciences

Somerset, New Jersey, United States

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 Microbiologist, Clinical QC Operations and Sciences as part of the Technical Development team based in Somerset, NJ. 

Role Overview

The Sr. Advanced Microbiologist, Clinical QC Operations and Sciences will be responsible for providing technical strategy and performing related activities necessary to start up and perform routine operations within a new in-house GMP facility and delivering 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 quality, IT, facilities, safety, and operations to establish the systems necessary to operate a GMP manufacturing facility for the purpose of producing Phase 1 products.  The following activities will include implementing environmental monitoring and aseptic qualifications to support the release of cell and gene therapy product candidates. Additionally, the successful candidate will lead the environmental monitoring program, complex investigations, and coordinate with external parties for testing.

Key Responsibilities  

  • Create and author environmental monitoring, aseptic operation simulation/validation protocols, and additional procedures necessary to operate a GMP manufacturing facility at Phase 1 clinical standards.
  • Develop, implement, and manage a comprehensive environmental monitoring (EM) strategy and program for cleanroom and controlled areas.
  • Schedule routine and batch testing in collaboration with related functions including quality, facilities, safety, operations, and contract testing labs.
  • Work cross-functionally with analytical development to perform method transfers and qualifications within the QC laboratory.
  • Review and approve endotoxin, sterility, and mycoplasma 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 endotoxin, sterility, and mycoplasma for cell and gene therapy products in collaboration with related functions including development, quality, IT, facilities, safety, and operations.
  • Perform complex laboratory investigations including organism identification, OOS, and deviations.
  • Author and review investigation reports, CAPAs, and change controls.
  • Drive continuous improvement initiatives to reduce error rates.
  • Represent QC micro in cross-functional meetings and project teams, providing subject matter expertise on environmental monitoring, sterility assurance, and regulatory expectations.
  • Coordinate with contract testing labs (CTL) to send samples for external testing and investigate out-of-specification results collaboratively with CTL.
  • Author and lead execution of aseptic operator and process simulation protocols.
  • Establish cleaning procedures and requirements to ensure proper sanitization of a Phase 1 GMP manufacturing facility.
  • Train GMP personnel on aseptic requirements and behaviors.
  • 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 microbiology/sterility assurance including operations, supervision, and strategy setting
  • Knowledge and experience with cell and gene therapy manufacturing environmental monitoring and sterility assurance
  • Familiarity with viral vector manufacturing environmental monitoring and sterility assurance
  • Experience establishing and operating in a GMP environment
  • Familiarity with cell and gene therapy environmental monitoring equipment
  • 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
  • Experience with aseptic processing
  • Patient focus is a must

#Li-JR1

#Li-Hybrid

The anticipated base pay range is:

$107,482 - $141,070 USD

Benefits:

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.

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