QC Microbiology Supervisor - Cell Therapy Ops

BioNJ Inc.; Raritan (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Legend Biotech is seeking a Supervisor, QC Microbiology in Raritan, NJ to lead the QC microbiology laboratories within the Quality Operations team. The role includes staff hiring, development, data review, procedure implementation, and investigations in support of cell therapy manufacturing.

Ideal candidates will have a Bachelor's degree in science or engineering, 6+ years of relevant experience, and at least 1 year in a leadership role.

Qualifications

• Bachelor's degree in science, engineering, or an equivalent technical discipline.
• 6+ years of relevant work experience, preferably in aseptic manufacturing, quality control, quality assurance, or cell therapy.
• Minimum of 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 basic and advanced mathematical concepts (including statistics) to evaluate laboratory data.
• Excellent written and verbal communication skills.
• Willingness to travel to NJ/PA partner sites as needed.
• Candidates must accommodate unplanned overtime (nights/weekends).

Responsibilities

• Supervise operation and workflow of the QC microbiology laboratories.
• Hire, develop and manage staff; review laboratory data and approve test results.
• Develop and implement microbiology procedures and methods; support investigations.
• Train staff on skills-based, cGMP and safety requirements.
• Schedule daily activities and manage department budget and resources.
• Collaborate with QA, Manufacturing, Technical Operations, Engineering and Maintenance.
• Ensure compliance with safety policies and quality systems.

Skills

Leadership experience

People management

cGMP knowledge

FDA/EU guidance knowledge

Quality systems

Statistical data analysis

Communication skills

Education

Bachelor's Degree in Science, Engineering or equivalent technical discipline

Job description

Legend Biotech is seeking a Supervisor, QC Microbiology in Raritan, NJ to lead the QC microbiology laboratories within the Quality Operations team. The role includes staff hiring, development, data review, procedure implementation, and investigations in support of cell therapy manufacturing.

Ideal candidates will have a Bachelor's degree in science or engineering, 6+ years of relevant experience, and at least 1 year in a leadership role.