Senior Quality Control Analyst
10 hours ago
Legend Biotech US is seeking a highly skilled and experienced Sr. QC Analyst to join our Quality team based in Raritan, NJ.
Job Summary:The Sr. QC Analyst 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. This role requires a strong understanding of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products.
Key Responsibilities:- Perform 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 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.
- 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 skills 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.
Legend Biotech US is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.
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