Senior Principal Microbiologist

Lilly • Concord, NC

34d

About The Position

The Sr. Principal Microbiologist influences and participates in the design and installation of systems, procedures, and methods for the startup of the QC Microbiological testing and environmental monitoring labs at the site. Additionally, the Sr. Principal Microbiologist participates in the design, installation, qualification, and startup of Clean Utilities systems supporting GMP manufacturing operations. This role provides technical leadership for microbiological control strategies for Purified Water (PW), Water for Injection (WFI), clean steam, compressed gases, and associated distribution systems. The Sr. Principal Microbiologist leads and supports Clean Utilities qualification, validation, technology transfer, remediation, and lifecycle management activities. The Sr. Principal Microbiologist leads the design and execution of method development, validations, technology transfers, and equipment evaluation/qualification. The Sr. Principal Microbiologist utilizes their technical skills to ensure inspection readiness, perform in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results. Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented by the Sr. Principal Microbiologist and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of lab staff, sharing technical information and best practice within the work group and across plant sites.

Requirements

• Bachelors (4-year) degree in a science field related to microbiology or biology.
• 7-10 years of demonstrated relevant experience in a GMP Microbiology Laboratory, preferably associated with GMP manufacturing.
• Leadership and influence
• Demonstrated proficiency in laboratory analysis including, but not limited to endotoxin, bioburden, sterility, bioassay, particulate matter, and organism identification.
• Strong oral and written communication skills and demonstrated through documentation and presentation skills.

Nice To Haves

• Demonstrated strong problem-solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology.
• Demonstrated strong interpersonal interaction skills.
• Ability to focus on continuous improvement.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
• Deep understanding of compliance requirements and regulatory expectations.

Responsibilities

• Technical review, interpretation, and release of raw material, in-process, and finished product data.
• Serve as subject‑matter expert for Clean Utilities systems, including PW, WFI, clean steam, and critical process gases.
• Serve as subject-matter expert for Microbiological Test Methods
• Support qualification, validation, and lifecycle management of Clean Utilities systems.
• Contributes to annual product reviews and process validations as required.
• Perform technical training and mentor analysts through formal process/program.
• Lead and/or review change controls and complex deviations.
• Utilizes technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
• Lead investigations into Clean Utilities excursions and adverse trends.
• Develop investigational testing protocols and perform testing as required.
• Author and oversee the execution of method verifications, transfers, and validations.
• Monitor method and process performance.
• Improve lab quality systems; develop content, review, and approve SOPs and training as necessary.
• Contribute to development and implementation of Global Lab Quality Standards.
• Comply with and implement safety standards.
• Provide technical oversight for Periodic Management Reviews.
• Interacts effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements.
• SME for internal and external inspections, interacting directly with inspectors and regulatory agencies.
• Notification to management of quality issues.
• Interaction with other functions and auditors.
• Participation in internal/external audits.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior