Senior Principal Microbiologist

Lilly • Concord, NC

51d • $65,250 - $169,400 • Onsite

About The Position

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Company Overview:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. #WeAreLilly

Organization Overview:
Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

Position Description:
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.

Key Objectives/Deliverables:
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.
Types of communication include:
Notification to management of quality issues.
Interaction with other functions and auditors.
Participation in internal/external audits.

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.
• 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.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

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

• 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.
• Participates in the design, installation, qualification, and startup of Clean Utilities systems supporting GMP manufacturing operations.
• Provides technical leadership for microbiological control strategies for Purified Water (PW), Water for Injection (WFI), clean steam, compressed gases, and associated distribution systems.
• Leads and supports Clean Utilities qualification, validation, technology transfer, remediation, and lifecycle management activities.
• Leads the design and execution of method development, validations, technology transfers, and equipment evaluation/qualification.
• Utilizes 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.
• Documents outcomes of activities including results, conclusions, and action plans thoroughly and accurately, and may publish in regulatory and/or technical documents.
• Provides technical mentoring of lab staff, sharing technical information and best practice within the work group and across plant sites.
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• 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