Sr. Principal Microbiologist

About the role

The Senior Principal Microbiologist - Technical Services/Manufacturing Sciences (TS/MS) position plays a crucial role in establishing and implementing microbiological, viral, and environmental monitoring programs at the newly established GMP manufacturing facility in Richmond, VA. This role supports the facility's start-up and ensures a safe and successful transition while contributing to Lilly's mission of developing innovative medicines.

Responsibilities

• Establish and implement microbial and viral control strategies in collaboration with Engineering, Operations, Quality Control, and Quality Assurance.
• Support the development and transfer of a robust microbial control strategy in partnership with network and development organizations.
• 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 and ensure compliance with safety, compliance, and regulatory expectations.
• Contribute to regulatory submissions and responses to health authorities.
• Act as the microbiology Subject Matter Expert during health authority inspections.

Requirements

• Bachelor’s degree in microbiology, biotechnology, biochemistry, or a related field.
• Experience in biological GMP manufacturing environments, preferably in a frontline microbiological support role.
• Deep knowledge of microbiological controls and associated analytical tests in biological manufacturing.
• Understanding of molecule-specific control strategies and basis of specifications.
• Experience with contamination control strategies.
• Strong technical capability and productivity.
• Curiosity and learning agility.
• Strong interpersonal and communication skills.
• Adaptability and flexibility to work in various environments and teams.
• Ability to participate in and facilitate decision-making processes.

Basic Requirements

• BS degree in microbiology, biotechnology, biochemistry or similar discipline.
• Experience (>5 years) in biological GMP manufacturing environment.

Additional Preferences

• MS or PhD in microbiology, biotechnology, biochemistry or similar discipline.
• Experience with contamination control strategies.
• Proven track record of curiosity and learning agility.
• Strong interpersonal and communication skills.
• Adaptability and flexibility to work in different environments and teams.
• Demonstrated ability to participate in and facilitate decision-making processes.

Pay

$102,000 - $171,600

Schedule

Full-time equivalent employees are eligible for a company bonus (depending, in part, on company and individual performance).