Senior Microbiologist — GMP Lab & Clean Utilities Lead

BioSpace; Concord (NC); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly in Concord, NC seeks a Sr. Principal Microbiologist to lead the design and startup of QC Microbiological testing labs and Clean Utilities systems for GMP manufacturing.

This role provides technical leadership for microbial control strategies and lifecycle management, including method development, validation, and tech transfer. You will mentor staff, ensure inspection readiness, and document results thoroughly for regulatory and technical communication.

Qualifications

• Bachelor's degree in a science field related to microbiology or biology.
• Demonstrated 7–10 years of GMP microbiology laboratory experience, preferably in GMP manufacturing.
• Strong oral and written communication skills evidenced by documentation and presentations.

Responsibilities

• Technical review, interpretation, and release of raw material, in-process, and finished product data.
• Lead and support Clean Utilities qualification, validation, and lifecycle management.
• Design, development, validation, and transfer of microbiological methods.
• Mentor analysts and provide technical oversight for inspections.
• Investigate out-of-spec results, perform root cause analysis, and implement corrective actions.

Skills

Technical leadership

GMP Microbiology

Microbiological testing

Environmental monitoring

Root cause analysis

Communication skills

Education

Bachelor's degree in microbiology or biology

Tools

LIMS (Laboratory Information Management System)

Job description

Lilly in Concord, NC seeks a Sr. Principal Microbiologist to lead the design and startup of QC Microbiological testing labs and Clean Utilities systems for GMP manufacturing.

This role provides technical leadership for microbial control strategies and lifecycle management, including method development, validation, and tech transfer. You will mentor staff, ensure inspection readiness, and document results thoroughly for regulatory and technical communication.