US05 Lonza Houston Inc.
Head of Microbiology, Quality Control (Biotech)
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.
At our Lonza Houston Cell and Gene Therapy facility we are produce and supply several commercial Cell and Gene therapies and work on many development projects in all Cell and Gene areas: Viral Vector, Autologous and Allogenic Therapies. With almost 1000 highly skilled employees, the Lonza Houston Cell and Gene site is one of the largest of its kind worldwide across the industry.
The position: Currently, we are looking for a Head of Microbiology at the Lonza Houston Cell and Gene Therapy facility. The incumbent will lead a team of approximately 35 associates and will oversee all aspects of the microbial control program helping to assure compliant, effective and modern contamination control strategy at the Lonza Houston Site. This includes all Microbiology Sterility Testing and Environmental Monitoring Quality Control activities, end-to-end, for all products and projects at the site. For the position, significant working experience in Microbiology and/or Sterility Assurance and/or sterile manufacturing is necessary. A Bachelor`s degree in Science is the minimum requirement, MS or Ph.D. are preferred. We expect hands-on leadership style to assure the Microbiology testing and Environmental monitoring teams exhibit solution orientated approaches at each level of the organization. The Job incumbent will be on-site and will represent the site and Lonza in all client interactions for all questions related to the scope of the position. This includes assuring setting projects and priorities to assure successful completion of the department on-time or ahead of schedule of all assigned tasks. The incumbent will be responsible for the budget of the department.
The incumbent will act as leading source for managing a state of the art contamination control strategy across the site in close collaboration with the Asset Heads and covering respective procedures, maintenance of disinfection efficacy studies, leadership for complex investigations, microbiological trending programs and resulting continual improvements holistically for all topics related to the contamination control strategy of the site.
Quality: The Head of Microbiology will be part of the Quality Lead Team at the site. He or she will assure Quality beyond Compliance assuring current GMP standards in line with most recent and current regulatory requirements and guidelines for all activities related to the scope of the position. Working experience and end-to-end understanding of aseptic processing, environmental and utility monitoring, clean room qualification, and microbiological testing is a must. He or she will represent the site in all audits and inspections related to Microbiology testing and Environmental Monitoring. In view of the numerous additional commercializations expected, the applicant must have a solid track record of commercial filings, and also direct US FDA front room inspection experience where he or she he or she managed the Microbiology Testing and Environmental Monitoring part.
Operations: The job incumbent will be responsible for all lab Quality Control Operations related to Microbiology Sterility testing and Environmental Monitoring. The expectation is to set up the Microbiology and Environmental Monitoring labs in the most efficient way to assure Lean Lab Operational Excellence. Thus, the incumbent is required to have profound Lean Six Sigma background with a track record of transitioning Quality Control lab organizations to next level efficiency and productivity. As part of the role, it is expected to also introduce and lead through the implementation of state-of-the art new technologies such as fast track sterility testing and automatization of Environmental Monitoring programs.
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.