Senior Manufacturing Manager, Gene Therapy
United States, Houston (Texas)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
The Senior Manufacturing Manager is responsible to oversee the production of Gene Therapy (Viral Vector) Products under Good Manufacturing Practices (cGMP) conditions. This role will plan and prepare for production, schedule tasks, and assign duties to supervisors to meet the production schedule, assess production records and meet release timelines to deliver quality product to our customers. They own performance and the quality of the work of the team, ensuring adherence to written procedures (SOPs), housekeeping, 6S, daily management system (DMS), monitoring equipment and processes, laboratory tasks, product sampling, and equipment sanitization tasks to maintain facility are performed to the expected standards.
- Responsible for training department personnel on equipment operation, cGMPs, documentation, technical theory, or other tasks.
- Review documentation (batch records, Standard Operating Procedures (SOPs), Logbooks for completeness, clarity, accuracy and submit edits to documents for revision as required.
- Responsible for reviewing, writing, and executing validation production records.
- Manage operations across multiple shifts/locations
- Administrative tasks – leading shift exchange, meetings, sending/receiving emails, participating in projects.
- Directs the manufacturing activities.
- Responsible for ensuring product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry practices.
- Responsible for compiling and analyzing validation data, preparing reports and making recommendations for changes and/or improvements.
- Responsible for Investigating and troubleshooting problems.
- Responsible for training/mentoring new hires and transfers within the department.
- May require 25% domestic and international travel.
- High School Diploma. Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering/ Masters of Science or Engineering highly preferred.
- Extensive experience in manufacturing; GMP setting preferred.
- Coordinate activities across multiple departments to troubleshoot complex and non-routine equipment events
- Ability to represent organization in front of customers and inspectors when required.
- Ability to lead GMP training for new and current employees
- Assume responsibilities for covering Head of Viral Vector Manufacturing during absences/vacations
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.