Director, QC Microbiology — Cell Therapy Quality Leader

Bristol Myers Squibb; Utah; On-site; USD 185,000 - 224,000; Full time

Job summary

Bristol Myers Squibb invites applications for a Director, QC Microbiology at the CAR T facility in Summit West, NJ. The leader will oversee Quality Control Microbiology operations, stability testing, environmental monitoring, method validations, and investigations while guiding a team in a cGMP environment.

The role requires extensive regulatory knowledge, leadership of direct reports, cross-functional collaboration, and budget/headcount management.

Qualifications

• Bachelor's degree in Chemistry or Microbiology required
• 10 years of relevant work experience required
• Leadership experience with direct reports required
• Advanced knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations
• Able to collaborate cross-functionally to drive operational and quality excellence
• Proficient in developing and managing budgets/headcounts
• Strong training and mentoring capabilities
• Ability to design and improve microbiology lab spaces and drive lean initiatives
• Understanding of data integrity principles and regulatory inspections

Responsibilities

• Manage all QC Microbiology activities including stability testing and materials testing
• Oversee environmental monitoring and method validation/maintenance
• Lead investigations and data analysis
• Develop and manage departmental budget and headcount
• Coach and develop direct reports and ensure training/qualification
• Collaborate across functions to meet manufacturing and laboratory schedules
• Drive lean lab initiatives and continuous improvement

Skills

Regulatory knowledge

Communication

Cross-functional collaboration

Organization

Problem solving

Mentoring

Strategic thinking

Leadership

Quality systems

Data integrity

Regulatory inspections

Training

MS Office

Budget management

Headcount planning

Project management

Lean lab

Microbiology assays

Education

Bachelor's degree in Microbiology

Advanced degree preferred

Tools

MS Office

Job description

Bristol Myers Squibb invites applications for a Director, QC Microbiology at the CAR T facility in Summit West, NJ. The leader will oversee Quality Control Microbiology operations, stability testing, environmental monitoring, method validations, and investigations while guiding a team in a cGMP environment.

The role requires extensive regulatory knowledge, leadership of direct reports, cross-functional collaboration, and budget/headcount management.