QC, Analyst I

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.
• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Create, review and approve relevant QC documents, SOP’s and WI’s.
• Utilize electronic systems (LIMS) for execution and documentation of testing.
• Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development.

Requirements

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
• Experience in a Quality Control setting is preferred.
• Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred.
• Knowledge of Good Tissue Practices is required.
• Knowledge of CAR-T QC test methods and related equipment is preferred.
• Excellent written and oral communication skill are required.