Senior Principal Microbiologist - QC Lab & Clean Utilities

BioSpace; Concord (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Lilly is designing a new parenteral, device, and packaging facility in Concord, NC. The Sr. Principal Microbiologist will lead microbiological control strategies and QC lab startup activities, ensuring regulatory compliance and readiness for inspections.

They will mentor staff, drive method development and validations, and collaborate across functions to improve quality systems and document investigations thoroughly.

Qualifications

• Education: Bachelor's degree in a science field related to microbiology or biology.
• 7–10 years GMP Microbiology Lab experience.
• Demonstrated leadership and influence in a lab setting.

Responsibilities

• Technical review and release of raw material, in-process, and finished product data.
• Subject-matter expert for Clean Utilities systems and Microbiological Test Methods.
• Lead investigations into deviations and out-of-spec results and root cause analysis.
• Support qualification, validation, and lifecycle management of Clean Utilities systems.
• Mentor analysts and contribute to SOPs and training.

Skills

Leadership

Microbiology

GMP

Laboratory analysis

Endotoxin testing

Bioburden testing

Sterility testing

Education

Bachelor's degree in microbiology/biology

Tools

Laboratory instruments

Job description

Lilly is designing a new parenteral, device, and packaging facility in Concord, NC. The Sr. Principal Microbiologist will lead microbiological control strategies and QC lab startup activities, ensuring regulatory compliance and readiness for inspections.

They will mentor staff, drive method development and validations, and collaborate across functions to improve quality systems and document investigations thoroughly.