Senior QC Microbiology Lead for Cell Therapy Manufacturing

Legend Biotech USA, Inc.; Raritan (NJ); On-site; USD 146,000 - 192,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Parental leave

Paid time off

Flexible spending accounts

Life and AD&D insurance

Job summary

Legend Biotech USA, Inc. is seeking a Sr. Manager, QC Microbiology in Raritan, NJ, to lead the QC microbiology laboratories supporting CAR-T cell therapy manufacturing.

The role includes staff leadership, data review, method validation, investigations, and cross-functional collaboration to ensure compliance with cGMP and regulatory requirements. The ideal candidate holds a B.S. in Science with 12–14 years of related experience, including aseptic manufacturing and at least 3–5 years in a

Qualifications

• Bachelor's Degree in Science or equivalent required.
• 12–14 years of relevant experience preferred, with aseptic manufacturing exposure.
• 3–5 years of leadership experience required.
• Experience with Quality systems and cGMP FDA/EU guidance.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Train and develop staff with cGMP and safety in mind.
• Manage QC microbiology materials, testing, and investigations.
• Oversee instrument maintenance, calibration, and qualification.
• Lead method verification, qualification, validation or transfer activities.
• Collaborate with QA, Manufacturing, Engineering and Maintenance.

Skills

Leadership

QC Microbiology

cGMP knowledge

Regulatory knowledge

Data analysis

Education

Bachelor's Degree in Science

Job description

Legend Biotech USA, Inc. is seeking a Sr. Manager, QC Microbiology in Raritan, NJ, to lead the QC microbiology laboratories supporting CAR-T cell therapy manufacturing.

The role includes staff leadership, data review, method validation, investigations, and cross-functional collaboration to ensure compliance with cGMP and regulatory requirements. The ideal candidate holds a B.S. in Science with 12–14 years of related experience, including aseptic manufacturing and at least 3–5 years in a