Manager, QC Microbiology Environmental Monitoring

Manager, QC Microbiology Environmental Monitoring

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Manages the QC Microbiology team which is responsible for environmental monitoring (routine and production), utility monitoring, and with the knowledge of microbiology testing such as bioburden, endotoxin, gram stain, and growth performance qualification.  Responsible for oversight of the environmental monitoring (EM) program including establishment of sampling plans, routine trending, and excursion response procedures in accordance with applicable regulatory guidelines and Lonza policy.

Key responsibilities:

• Responsible for supervision of the EM team.  Acts as an advisor to subordinates when determining how to meet schedules and/or resolve technical problems.  Reviews testing and laboratory records for accuracy and compliance with cGMP and Lonza policies and principles.   

• Responsible for development of site Environmental and Utility monitoring programs and policies.  Ensures sampling plans are up to date and executed as planned.   

• Owns site environmental monitoring and utility trend program.  Hosts monthly trending meetings, responsible for sharing trend information with the site Quality Council and identifies and escalates adverse trends appropriately. Drives corrective/preventative actions, ensuring work is complete and the site remains in a state of control.   

• Leads environmental excursion investigations.  Ensures corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the monthly trending meetings. 

• Writes, reviews, and/or approves SOPs, sampling plans, and protocols.   

• Develops and maintains a tool for monitoring QC resource capacity.  Provides feedback to QC management, program management, and production planners when capacity constraints exist.    

• Leads, mentors, and coaches’ staff through routine one-on-one meetings, team meetings, and effective performance management.  Sets and delivers on individual and team goals that support the department and site strategy.  Takes personal accountability for both his/her own and the team’s actions.     

• Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).   

• Prepares project plans, writes status reports, and gives oral presentations to customers and management.   

• Prepares monthly management reports including budget analysis and project updates.   Actively monitors spending for area. Predicts and escalates potential spending variances.  Identifies corrective actions for spending variances.   

• Develops and monitors team performance measures to understand effectiveness, efficiency, and quality of group performance. 

• Performs other duties as assigned. 

Key requirements:

• Expertise in aseptic processing, environmental monitoring, cleanroom qualification, and microbiological testing.

• Data Analysis & Investigations: Skilled in trending environmental/utility data and leading contamination/excursion investigations.

• Training & Gap Remediation: Proficient in developing training plans and addressing training gaps to ensure compliance.

• Software Proficiency: Pr