QC Microbiology Manager - Cell Therapy (CAR-T)

Bristol-Myers Squibb Co; Harvard (MA); On-site; USD 100,000 - 122,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

Paid vacation & holidays

Job summary

Bristol Myers Squibb is seeking a Manager, QC Microbiology to lead the QC Microbiology Laboratory supporting CAR T manufacturing at the Devens, MA site. You will supervise testing, data review, and CAPA processes, ensuring compliance with FDA and international guidelines.

The role requires leadership experience, strong cGMP knowledge, and collaboration across QA and manufacturing to maintain quality and regulatory readiness.

Qualifications

• Bachelor’s degree in Microbiology or related science.
• 7+ years in Microbiology lab and/or Environmental Monitoring.
• 2 years of leadership experience.
• Experience with regulatory audits (FDA, MHRA, PMDA, TGA) preferred.
• Experience supporting sterile compounding and filling operations.
• Strong knowledge of cGMPs and quality systems.

Responsibilities

• Manage QC Microbiology department and testing program.
• Ensure timely testing, release, and CAPA investigations.
• Develop and manage SOPs and methods for QC Microbiology.
• Lead regulatory inspection support as SME.

Skills

cGMP knowledge

Data integrity

Leadership

Laboratory testing

Education

Bachelor's degree in Microbiology

Advanced degree preferred

Tools

eQMS

Microsoft Office

Job description

Bristol Myers Squibb is seeking a Manager, QC Microbiology to lead the QC Microbiology Laboratory supporting CAR T manufacturing at the Devens, MA site. You will supervise testing, data review, and CAPA processes, ensuring compliance with FDA and international guidelines.

The role requires leadership experience, strong cGMP knowledge, and collaboration across QA and manufacturing to maintain quality and regulatory readiness.