Senior QC Microbiology Supervisor - Cell Therapy

Legend Biotech, Inc.; Raritan (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Legend Biotech seeks a Supervisor, QC Microbiology to lead the operation and workflow of the QC microbiology laboratories in support of cell therapy manufacturing in Raritan, NJ. The role includes hiring, staff development, and ownership of laboratory data review along with method development and regulatory compliance.

The ideal candidate has a Bachelor's in Science/Engineering, 6+ years in the field (including leadership), and strong knowledge of cGMP, QA systems, and laboratory investigations.

Qualifications

• Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
• Minimum of 6 years relevant work experience; aseptic manufacturing facility experience preferred.
• At least 1 year of leadership experience is required.
• Experience with Quality systems, cGMP regulations and FDA/EU guidance is required.
• Experience with clinical quality, method development, cell therapy, or R&D is preferred.

Responsibilities

• Provide training (skills-based, cGMP and safety) for associates within the department.
• Oversee raw material, in-process, environmental/utility, and product release testing.
• Schedule daily activities for personnel and manage workload.
• Investigate laboratory non-conformances (events, deviations, invalid assays).
• Maintain calibration and qualification of laboratory instruments/equipment.
• Lead test method verification, qualification, validation and transfer activities in QC laboratories.
• Support Process Performance Qualification and Continued Process Verification activities.
• Collaborate with QA, Manufacturing, Technical Operations, Engineering and Maintenance.

Skills

Leadership

GMP knowledge

Analytical skills

Communication

Education

Bachelor's Degree in Science/Engineering

Job description

Legend Biotech seeks a Supervisor, QC Microbiology to lead the operation and workflow of the QC microbiology laboratories in support of cell therapy manufacturing in Raritan, NJ. The role includes hiring, staff development, and ownership of laboratory data review along with method development and regulatory compliance.

The ideal candidate has a Bachelor's in Science/Engineering, 6+ years in the field (including leadership), and strong knowledge of cGMP, QA systems, and laboratory investigations.