Viral Vector Senior Manager Filling Operations
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.
Lonza Houston’s Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity in Viral Vector Therapy https://pharma.lonza.com/offerings/cell-and-gene-therapies/viral-vector-gene-therapy. The Senior Manager for Filling Operations will be responsible to oversee the Filling operations under cGMP conditions. The Sr. Manager is expected to 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. The Sr. Manager is expected to set the example safety and compliance for their teams, and demonstrate expertise and breadth of knowledge in executing processes across a variety of production activities. 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. The manager is expected to ensure their team is trained and coach their team members, review and manage performance, and support career development for staff. They are expected to demonstrate expertise and technical leadership in cGMP compliance and an in-depth understanding of process flow and be able to make decisions based on that experience. The Sr. Manager is able to coordinate activities across multiple departments to troubleshoot complex and non-routine equipment events, communicate effectively, initiate, assess, and close all deviations, review batch records and logbooks when required. Assists in the preparation for Agency and customer inspections and may represent the Manufacturing department on project teams, ensuring that quality requirements are met. Other duties may include conducting cGMP training for new and current employees, participation in internal and external audits as required, reviewing cGMP records, change control, and overall cGMP compliance, assists in the preparation for Agency and customer inspections and may represent the Manufacturing department on project teams, ensuring that quality requirements are met.
- Responsible for training department personnel on equipment operation, cGMPs, documentation, technical theory, or other tasks.
- Maintain individual training plan.
- Review documentation (batch records, 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.
- Perform other duties as assigned
- 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
- Bachelor’s Degree in Biotechnology, Biology, Chemistry, or equivalent with Associates degree
- High School Diploma or Equivalent may be considered with relevant experience
- In depth knowledge of pharmaceutical manufacturing, safe work environment leadership, delivery of RFT, and leadership and development of leadership teams delivering progressive continuous improvement in a multi-layered organization.
- Expert Level knowledge of cGMP facilities and cGMP requirements and API.
- Expert Level experience in biomanufacturing; GMP setting required,
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.