CAR-T Manufacturing Quality Control Specialist

4 days ago

Raritan, New Jersey, United States Legend Biotech US Full time
Job Summary

Legend Biotech US is seeking a highly skilled Quality Control Specialist to join our team in Raritan, NJ. As a key member of our Quality team, you will be responsible for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Key Responsibilities
  • Perform QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment.
  • Ensure testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
  • Work with the Process Development team, Quality, and Operations organization to successfully transfer process/analytical testing to a cGMP facility to manufacture products.
  • Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
  • Perform peer review/approval of laboratory data.
  • Utilize electronic systems (LIMS) for execution and documentation of testing.
  • Create, review, and approve relevant QC documents, SOPs, and WI's.
  • Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
Requirements
  • Bachelor's Degree in Science, Engineering, or equivalent technical discipline.
  • Minimum of 1 year of relevant work experience, preferably within a biological and/or pharmaceutical industry.
  • Experience in a Quality Control setting is preferred.
  • Detailed knowledge of CAR-T QC test methods and related equipment is preferred.
  • Candidates must be able to accommodate shift schedules, including 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.
  • 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.
About Legend Biotech US

Legend Biotech US is a global biotechnology company dedicated to treating and one day curing life-threatening diseases. We are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

We entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autoleucel (cilta-cel) in 2017.

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.

We are committed to ensuring 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 law.

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