Senior Principal Microbiologist

About the role

The Sr. Principal Microbiologist plays a crucial role in the Quality Control Laboratory of Lilly's new state-of-the-art Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina. This role involves influencing and participating in the design and installation of systems, procedures, and methods for the startup of microbiological testing and environmental monitoring labs. Additionally, the role includes the design, installation, qualification, and startup of Clean Utilities systems supporting GMP manufacturing operations.

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 Purified Water (PW), Water for Injection (WFI), clean steam, and critical process gases.
• Support qualification, validation, and lifecycle management of Clean Utilities systems.
• Contribute to annual product reviews and process validations as required.
• 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.
• Draw conclusions and perform root cause analysis investigations and recommend 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.
• Maintain and 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 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.
• Notify management of quality issues.
• Participate in internal/external audits.

Requirements

• Bachelor's degree in a science field related to microbiology or biology.
• 7-10 years of 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.

Qualifications

• 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.

Skills

• Demonstrated strong problem-solving skills.
• 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.

Benefits

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).