QC Microbiology Lead, Cell Therapy

BioSpace; Raritan (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

Legend Biotech, based in Bridgewater, NJ, seeks a Supervisor, QC Microbiology to lead the QC microbiology laboratories in support of cell therapy manufacturing. Responsibilities include staff development, data review, method development, and assay transfers.

This exempt role requires a Bachelor's in science/engineering, 6+ years in quality-related labs, and at least 1 year of leadership. Travel to NJ/PA may be required; strong communication and regulatory knowledge are essential.

Qualifications

• Bachelor's degree in Science, Engineering or equivalent technical discipline is required.
• Minimum of 6 years relevant work experience; aseptic manufacturing facility preferred.
• At least 1 year of leadership experience is required.
• Experience with quality systems is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required.
• Ability to apply mathematics to evaluate laboratory data.

Responsibilities

• Ensure proper skills-based, cGMP and safety training for staff.
• Perform raw material, in-process, environmental, utility, and product release testing.
• Schedule daily activities for personnel in the QC microbiology lab.
• Investigate non-conformances, deviations and invalid assays.
• Maintain calibration and qualification of instruments and equipment.
• Oversee test method verification, qualification, validation and transfer.
• Lead Process Performance Qualification and Continued Process Verification activities.
• Collaborate with QA, Manufacturing, Technical Operations, Engineering and Maintenance.

Skills

People management

Leadership

Quality systems

Education

Bachelor's Degree in Science/Engineering or equivalent

Job description

Legend Biotech, based in Bridgewater, NJ, seeks a Supervisor, QC Microbiology to lead the QC microbiology laboratories in support of cell therapy manufacturing. Responsibilities include staff development, data review, method development, and assay transfers.

This exempt role requires a Bachelor's in science/engineering, 6+ years in quality-related labs, and at least 1 year of leadership. Travel to NJ/PA may be required; strong communication and regulatory knowledge are essential.