Senior QC Microbiology Manager — Lead Cell Therapy Lab

BioSpace; Raritan (NJ); On-site; USD 146,000 - 192,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off (vacation, personal, etc

Flexible spending accounts / Health-s;

Job summary

Legend Biotech in Bridgewater, NJ, seeks a Sr. Manager, QC Microbiology to lead the QC microbiology labs supporting cell therapy manufacturing. You will hire, develop and manage staff, review test data, and drive microbiology procedures and investigations.

The role demands extensive cGMP knowledge, FDA guidance familiarity, and strong leadership in a regulated environment; travel up to 10% may be required. Base pay ranges from $146,410 to $192,164 USD per year.

Qualifications

• Bachelor’s in Science or biology required; technical discipline acceptable.
• 12–14 years of relevant work experience in aseptic manufacturing or QC/QA in cell therapy.
• 3–5 years of leadership experience required.

Responsibilities

• Train and develop staff per cGMP and safety requirements.
• Oversee raw materials, in-process, environmental monitoring, release and stability testing.
• Lead investigations of laboratory non-conformances and instrument issues.
• Maintain calibration/qualification of laboratory instruments.
• Perform method verification, qualification, validation or transfer in QC microbiology.
• Support Process Verification activities and continued process verification.
• Collaborate with QA, Manufacturing, Technical Operations, Engineering and Maintenance.

Skills

Leadership

cGMP

FDA guidelines

Microbiology knowledge

Test method verification

Data analysis

Collaboration

Education

Bachelor’s Degree in Science/Biology

Tools

Laboratory equipment

Job description

Legend Biotech in Bridgewater, NJ, seeks a Sr. Manager, QC Microbiology to lead the QC microbiology labs supporting cell therapy manufacturing. You will hire, develop and manage staff, review test data, and drive microbiology procedures and investigations.

The role demands extensive cGMP knowledge, FDA guidance familiarity, and strong leadership in a regulated environment; travel up to 10% may be required. Base pay ranges from $146,410 to $192,164 USD per year.