Microbiology Specialist

Legend Biotech is seeking a QA Microbiology Specialist as part of the Quality team based in Raritan, NJ. 

Role Overview

The QA Microbiology Specialist is an exempt level position with responsibilities for providing microbiological oversight and contamination control of the production of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment.  

Key Responsibilities  

• Work with Quality and Operations teams to monitor and audit the aseptic operations and processes in support of aseptic manufacturing of Car T products. 
• Ensure aseptic techniques to be performed for crucial process steps are followed and provide meaningful input to processing operations.
• Review and approve relevant GMP documents, SOP’s and WI’s.
• Support the Plant Microbiologist in ensuring the microbiological control strategy is consistent with cGMP company requirements.
• Play a proactive role in the design, maintenance and delivery of Operations aseptic techniques and deliver the microbiology awareness training program. In conjunction with manufacturing help improve training related to microbiological hygiene and contamination prevention.
• Evaluate and communicate key critical inputs to site environmental monitoring program.  Compose quarterly EM trend reports and support identification of appropriate corrective and preventative actions as required.
• Manage Aseptic Process Qualification program and schedule qualifications for personnel.
• Actively support Process microbiological investigations.
• Drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene.
• Identify risks and opportunities in relation to contamination control on the shop floor and drive follow up initiatives for improvement in close cooperation with operators, QC and operations management.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Requirements

• A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
• A minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Aseptic processing in ISO 5 clean room and biosafety cabinets.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
• Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
• Detailed knowledge of the shop floor manufacturing process.
• Comprehensive knowledge of trending using statistical analysis.
• Ability to pay attention to details and follow the procedures
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. 
• Good written and verbal communication skills are required
• The successful candidate must maintain written records of work in the form of notebooks, technical reports and protocols.
• Ability to summarize and present results, and experience with team-based collaborations is a must. 
• Flexible to work on weekends, as needed

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