QC Microbiology Specialist

Legend Biotech is seeking a QC Microbiology Specialist, Lentivirus CAR-T Manufacturing as part of the Quality team based in Raritan, NJ. The current openings are on the second and third shift. 

Role Overview

The QC Microbiology Specialist, Lentivirus Vector (LVV) CAR-T Manufacturing is an exempt level position with responsibilities for performing routine Environmental Monitoring sampling of the LVV facility to support clinical trials and commercial operations in a controlled GMP environment.

Major Responsibilities

• Responsible for performing routine EM sampling, including viable/non-viable air and surface sampling, related to the manufacturing of LVV used for autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment
• Responsible for performing compressed gas sampling in the manufacturing LVV facility
• Work with Process Development team, Quality and Operations organization to successfully transfer LVV manufacturing process to cGMP facility
• Create, review and approve relevant QC documents, SOP’s and WI’s
• 5Ensure microbiological control strategy is consistent with cGMP requirements
• Participate in training and delivery of Operations aseptic technique and microbiology awareness training program
• Support Aseptic Process Simulations and visual inspection of components
• Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
• Perform peer review/approval of laboratory data
• Utilize electronic systems (LIMS) for execution and documentation of testing
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
• Other duties will be assigned, as necessary

Key Relationships

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 2 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 routine and non-routine testing and sampling methods, techniques and related equipment is preferred
• Knowledge of Aseptic Process Simulations is preferred
• Detailed knowledge of the shop floor manufacturing process is preferred
• Comprehensive knowledge of trending using statistical analysis is preferred
• Ability to pay attention to details and follow the procedures is required
• 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