Sr. Principal Microbiologist

Senior Principal Microbiologist - Technical Services/Manufacturing Sciences (TS/MS)

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.

As our biologics pipeline continues to expand, Eli Lilly & Company has invested in a state-of-the-art new facility in Richmond, VA. To support this exciting new GMP manufacturing facility and ensure a safe and successful start-up, we are seeking talented individuals to contribute to establishing Lilly Richmond as a reliable supplier of our innovative medicines and furthering our goal of making a difference to people's lives.

The TS/MS Sr. Principal Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Richmond manufacturing site. As the microbiology lead for the facility, the successful candidate will provide technical support for facility start-up, defining microbial and viral control strategies in partnership with Engineering, Operations, Quality Control, and Quality Assurance. The role will provide support to upstream and downstream processing areas and will own activities such as EMPQ and preparation of strategy documentation including contamination FMEA and response plans and the product protection control strategy.

The successful applicant will have a deep technical expertise in their areas of responsibility and demonstrate strong data-driven decision-making and problem-solving capabilities. They will also work to continuously improve process efficiency by implementing new technologies for robust contamination control strategy and process improvements. They will maximize the benefits of a Digital Plant to gain in depth knowledge of the process through data analytics and Process Analytical Technology.

Key Responsibilities

• Have an in-depth knowledge of microbiological controls and associated analytical tests in biological manufacturing. Understand molecule-specific control strategy and basis of specifications and critical quality attributes.
• Work with the network and development organizations to ensure a well-understood, robust and fit-for-purpose microbial control strategy is developed and transferred
• Knowledge of virology controls required for mammalian cell culture, virus and mycoplasma analytical methodologies
• Establish and own the EMPQ program, contamination FMEA and contamination response plan
• Creates, revises, or reviews documents such as: SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, etc) and performs investigations as needed
• Understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance and monitoring needs are captured in manufacturing electronic documentation
• Work as part of cross-functional teams, and establish partnerships with applicable functions, operations and TSMS Lab to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team.
• Understand basic statistical methodologies engage with Statisticians to assign specifications, validation acceptance criteria, material sampling criteria and analysis of batch data for summary reports and product reviews.
• Identify process improvements and participate in implementation of Lean manufacturing initiatives
• Understand and ensure compliance with safety, compliance, and regulatory expectations
• Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies
• Serve as the microbiology Subject Matter Expert during…