Senior Principal Microbiologist

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.

Responsibilities

• Influence and participate 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.
• Participate in the design, installation, qualification, and startup of Clean Utilities systems supporting GMP manufacturing operations.
• Lead and support Clean Utilities qualification, validation, technology transfer, remediation, and lifecycle management activities.
• Lead and/or review change controls and complex deviations.
• Perform technical training and mentor analysts through formal process/program.
• 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.

Qualifications

• 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.