Quality Control - Biologist/Microbiology

About the position

The Quality Control Biologist/Microbiology position at Lilly involves overseeing the environmental monitoring (EM) program for the Research Triangle Park Facility. This role is crucial for ensuring compliance and safety in the manufacturing of parenteral drug products, focusing on contamination control and process improvement. The position requires technical leadership, data analysis, and collaboration across various departments to enhance manufacturing processes and maintain regulatory standards.

Responsibilities

• Assist in the safe and compliant execution of the environmental monitoring program for Lilly production areas.
• Provide technical leadership to the EM organization and understand scientific principles for manufacturing parenteral drug products.
• Develop and execute process and facility monitoring strategies focusing on microbial risk.
• Support start-up activities related to environmental monitoring sampling programs.
• Ensure compliance with environmental monitoring, aseptic process simulations, and sterility assurance programs at the manufacturing level.
• Provide technical guidance for the environmental monitoring program and root cause investigations.
• Analyze microbial and manufacturing data to identify trends and opportunities for improvement.
• Lead or support risk assessments related to the EM program.
• Create, execute, review, and approve technical documents related to the EM program.
• Maintain inspection readiness activities and interact with regulatory agencies during inspections.

Requirements

• Bachelor's degree in Microbiology, Biology, Biochemistry, or related scientific discipline.
• 8+ years' experience in parenteral manufacturing and environmental monitoring principles.

Nice-to-haves

• Strong proficiency in MODA.
• Effective written and oral communication skills.
• Effective interpersonal skills.
• Experience supporting cGMP manufacturing, particularly in operations and environmental monitoring.
• Strong self-management and organizational skills.
• Facility start-up and/or technical transfer experience.
• Experience with data trending and analysis.

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Professional development opportunities
• Employee resource groups for support and networking