Today, Lonza is a global leader in life sciences operating across five 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.
We have an outstanding opportunity for a Head of QC Microbiology and Environmental Monitoring at the Lonza Houston Cell and Gene Therapy facility. This role offers the chance to coordinate a dedicated team of approximately 40 associates, leading all aspects of a comprehensive microbial control program. The successful candidate will ensure compliant, effective, and modern contamination control strategies across the site, covering all Microbiology Sterility Testing and Environmental Monitoring Quality Control activities.
Key responsibilities:
Lead the QC Microbiology and Environmental Monitoring Program, ensuring detailed execution and compliance.
Supervise and mentor the QC Microbiology and Environmental Monitoring teams, encouraging a problem-solving approach.
Resolve technical and operational problems to meet commitments and maintain outstanding standards.
Review testing and laboratory records for accuracy and adherence to cGMP and Lonza policies.
Develop and implement site environmental and utility monitoring programs and policies.
Ensure sampling plans are current and completed as intended.
Be responsible for the site environmental monitoring and utility trend program, sharing insights with the Quality Council and advancing adverse trends appropriately.
Lead environmental excursion and microbial investigations, implementing timely corrective actions.
Collaborate with Sterility Assurance, QA, and Compliance to improve the microbial state of control.
Monitor QC resource capacity and provide feedback to management and planners regarding constraints.
Mentor and coach staff through regular meetings and performance management, setting and achieving team goals.
Responsible for monitoring QC resource capacity. Provides feedback to QC management, program management, and production planners when capacity constraints exist.
Prepare audit responses, deviations, and CAPA, ensuring detailed and timely resolutions.
Develop project plans, status reports, and deliver oral presentations to customers and management.
Prepare monthly management reports, including budget analysis and project updates, proactively addressing spending variances.
Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
Find opportunities for operational efficiencies while maintaining compliance.
Lead strategic projects in line with site and global quality strategy, supporting the Site Quality Plan and deliverables.
Key requirements:
Approximately 10 years of QC Microbiology experience and 10 years of leadership experience.
Bachelor's degree in microbiology; MS or Ph.D. preferred.
Proven experience in sterile manufacturing and aseptic processing.
Outstanding communication skills, both written and verbal.
Experience handling complex microbiology investigations and FDA or health authority audits.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.