Senior Principal Microbiologist

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

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.

Minimum Requirements

• Education
• Bachelors (4-year) degree in a science field related to microbiology or biology.

• Experience
• 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.

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

Additional Preferences

• 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.

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.

The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. 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). In addition, 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly