Sr. Principal Microbiologist

Overview

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. Our over 50,000 employees 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 expands, Lilly has invested in a state-of-the-art facility in Richmond, VA. To support this GMP manufacturing facility and ensure a safe start-up, we are seeking talented individuals to contribute to establishing Lilly Richmond as a reliable supplier of our medicines and to make a difference in people’s lives.

• Establish and implement operational microbiological, viral and environmental monitoring programs at the Richmond site; act as the microbiology lead for the facility.
• Provide technical support for facility start-up, defining microbial and viral control strategies in partnership with Engineering, Operations, Quality Control, and Quality Assurance.
• Support upstream and downstream processing areas and own activities such as EMPQ, contamination FMEA, response plans, and product protection control strategy.
• Develop and maintain strategy documentation, including contamination control strategies and data-driven decision-making to improve process efficiency.
• Maximize the benefits of a Digital Plant through data analytics and Process Analytical Technology to gain in-depth process knowledge.

• Establish and own the EMPQ program, contamination FMEA, and contamination response plan.
• Create, revise, or review documents such as SOPs, material specifications, protocols, and trend reports; perform investigations as needed.
• Ensure integration of process parameter requirements with MES/electronic batch records for regulatory, compliance and monitoring needs in manufacturing documentation.
• Collaborate with cross-functional teams and partner with applicable functions, operations and TSMS Lab to align science/engineering with floor operations and bring technical expertise to the team.
• Engage with statisticians to apply basic statistical methodologies for setting specifications, validation criteria, sampling, and analysis of batch data for reports and product reviews.
• Identify process improvements and participate in Lean manufacturing initiatives.
• Ensure compliance with safety, regulatory, and quality expectations; contribute to regulatory submissions and responses; serve as microbiology subject matter expert during health authority inspections.

• BS degree in microbiology, biotechnology, biochemistry or a similar discipline.
• Experience (>5 years) in a biological GMP manufacturing environment, providing frontline microbiological support.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not sponsor work authorization or visas for this role (including but not limited to F-1 CPT, OPT, STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, L-1).

• MS or PhD in microbiology, biotechnology, biochemistry or a related discipline.
• Experience with contamination control strategies.
• Demonstrated technical capability with high productivity and learning agility.
• Self-starter with data-driven problem-solving and strong interpersonal, verbal and written communication skills.
• Demonstrated adaptability to working in different environments and teams; ability to participate in and facilitate decision-making.

• Onsite. This is an 8-hour day role; occasional evening or weekend support may be required as a manufacturing support function.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities in the application process. If accommodation is required, please request via the accommodation form at the following URL:  This contact is for accommodation…