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QC Investigations Specialist II

Raritan, 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 QC Investigations Specialist II as part of the Quality team based in Raritan, NJ. 

Role Overview

The QC Investigations Specialist is an exempt level position with responsibilities for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Key Responsibilities  

  • Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.
  • Review/complete routine CAR-T manufacturing nonconformance/deviation investigations.
  • Proactively work with stakeholders to implement effective CAPAs and to ensure the timelycompletion of corrective and preventive actions within the laboratories.
  • Provide recommendations for the improvement of processes by working cross functionallywith multiple stakeholders.
  • Work closely with management to propose/execute improvements through the changemanagement system.
  • Ability to respond with a high degree of urgency to departmental and cross functional needs and requests.
  • Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA).
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMPrequirements.
  • Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development.

Requirements

  • A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
  • A Minimum of 4 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
  • Experience in a Quality Control setting is preferred.
  • Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-basedproducts is required.
  • Knowledge of Good Tissue Practices is required.
  • Detailed knowledge of CAR-T QC test methods and related equipment is preferred
  • Excellent written and oral communication skill are required
  • Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
  • Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
  • Comfortable with speaking and interacting with inspectors.
  • This position may require occasional travel to partner sites in NJ or PA as business demands.
  • This position may require up to 10% domestic or international travel as business demands.

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The anticipated base pay range is:

$75,972 - $99,713 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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