The Sr. QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities 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 Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment Ensure testing is completed in compl... more details
Company Information
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 and natural killer (NK) cell-based immunotherapy.
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) 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.
Legend Biotech is seeking Sr. QC Analyst (Third Shift) as part of the Quality team based in Raritan, NJ.
Role Overview
The Sr. QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities 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
Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment
Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations
Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to 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, SOP’s 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 is required
Must be able to work 3rd shift, 6PM-4:30AM
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-based products 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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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 law.
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