Senior Principal Microbiologist

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.

About the Role

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.

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, this role participates in the design, installation, qualification, and startup of Clean Utilities systems supporting GMP manufacturing operations. The Sr. Principal Microbiologist 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. This role also leads the design and execution of method development, validations, technology transfers, and equipment evaluation/qualification. The Sr. Principal Microbiologist 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.

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.
• Contribute 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.
• Utilize technical skills to lead or perform in-depth investigations into out-of-spec results and aberrant data, including root cause analysis and recommendations to prevent recurrence.
• 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.
• Interact effectively with business partners to communicate and resolve issues.
• Serve as subject-matter expert (SME) for internal and external inspections, interacting directly with inspectors and regulatory agencies.

Requirements

• Bachelor’s (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 demonstrated through documentation and presentation skills.
• 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.

Preferred Qualifications

• Demonstrated strong problem-solving skills and proficiency in Root Cause Analysis methodology.
• 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.

Other Information

• Tasks may require repetitive motion and standing for long periods of time.
• 8-hour days – Monday through Friday.
• Occasional shift work when required within the lab.
• Required to be available off-shift and respond to operational issues.
• Minimal travel required.

Pay

The anticipated wage for this position is $65,250 - $169,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• Comprehensive benefit program including 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).
• Company-sponsored 401(k) and pension plans.
• Vacation benefits.