Senior Principal Microbiologist – GMP Microbiology & Utilities

100 Eli Lilly and Company; Concord (NC); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical insurance

Job summary

Lilly is building a new Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina. The Sr.

Principal Microbiologist will lead microbiological control strategies, development, validation, and lifecycle management of Clean Utilities systems in a GMP environment. The role demands 7–10 years in GMP microbiology, strong problem-solving, and the ability to mentor analysts while ensuring regulatory inspection readiness.

Qualifications

• 7–10 years of GMP microbiology lab experience.
• Strong leadership and influence demonstrated in laboratory analysis.
• Excellent oral and written communication; able to document and present findings.
• Authorized to work in the United States on a full-time basis; visa sponsorship not provided.

Responsibilities

• Technical leadership for microbiological control strategies for PW, WFI, clean steam, and process gases.
• Lead design, qualification, startup, and lifecycle management of Clean Utilities systems.
• Oversee method development, validation, technology transfer, and equipment evaluation/qualification.
• Lead investigations into out-of-spec results and aberrant data with root-cause analysis and corrective actions.
• Mentor lab staff and coordinate cross-site knowledge sharing and training.
• Ensure inspection readiness and support for regulatory inspections.

Skills

Endotoxin testing

Bioburden

Sterility

Bioassay

Particulate matter

Organism identification

Leadership

Communication

Education

Bachelor's degree in microbiology

Job description

Lilly is building a new Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina. The Sr.

Principal Microbiologist will lead microbiological control strategies, development, validation, and lifecycle management of Clean Utilities systems in a GMP environment. The role demands 7–10 years in GMP microbiology, strong problem-solving, and the ability to mentor analysts while ensuring regulatory inspection readiness.