Lead QC Microbiology Manager, Cell Therapy

Bristol Myers Squibb; Harvard (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Bristol Myers Squibb seeks a Manager, QC Microbiology to lead the QC Microbiology Laboratory supporting CAR T manufacturing. This critical role ensures compliance with regulatory standards, oversees testing programs, and serves as SME during inspections.

The position involves managing personnel, developing SOPs, and coordinating release testing to ensure timely product supply. The role requires strong knowledge of cGMPs, FDA regulations, and Quality Systems, with leadership experience and a

Qualifications

• Bachelor's degree in Microbiology or related science; advanced degree preferred.
• 7 years' relevant work experience in Microbiology or Environmental Monitoring.
• 2 years of leadership experience preferred.
• Experience with regulatory audits (FDA, MHRA, PMDA, TGA) preferred.
• Experience with Quality Systems (SOPs, Deviations, CAPAs) preferred.

Responsibilities

• Manage QC Microbiology department and testing program.
• Coordinate laboratory testing schedules to support release and materials testing.
• Develop and manage SOPs, forms, and methods for compliant operation.
• Ensure test results stay within specifications; investigate deviations and implement CAPAs.

Skills

cGMPs knowledge

FDA regulations

Data integrity

Microbiology

Leadership

Regulatory audits

Environmental Monitoring

Education

Bachelor's degree in Microbiology or related science

Advanced degree preferred

Tools

eQMS systems

CAPA systems

Job description

Bristol Myers Squibb seeks a Manager, QC Microbiology to lead the QC Microbiology Laboratory supporting CAR T manufacturing. This critical role ensures compliance with regulatory standards, oversees testing programs, and serves as SME during inspections.

The position involves managing personnel, developing SOPs, and coordinating release testing to ensure timely product supply. The role requires strong knowledge of cGMPs, FDA regulations, and Quality Systems, with leadership experience and a