Process Assessment & Validation Manager
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 Process Assessment & Validation manager oversees several scientists and ensures the timely completion of MSAT deliverables in the area of process assessment and validation. You provide guidance to the team members and ensure the team performs at expected level and manages proper interaction between the team with other internal and external parties.
- Ensures successful completion of process assessment and validation activities as per agreed timeline in close collaboration with internal and external parties
- Ensures proper assessment on all process related areas including but not limited to the process steps, APS, facility, equipment and materials in compliance with GMP and ATMP regulations, identifying the risks and suggesting appropriate mitigation strategies.
- Manages process performance data trending during TT and post- TT, assessing the process performance and provides suggestions for process improvement
- Ensures ongoing process support for process in post-TT phases in case of process change, major deviation or applicable assessment when required.
- Ensures team members are competent for the assigned responsibilities by providing adequate coaching
- Actively participates in troubleshooting and serves as investigation lead for process impacting deviations and investigations.
- Ensures and encourages an Operational Excellence (OE) environment
- Develops and report metrics for clients to trend project progress in collaboration with PM
- Keeps current with advances in cell and gene therapy field technologies
- Ensures full adherence to the house procedures for all activities performed under his/her supervision
- Strongly collaborates with MSAT head on achieving the departmental goals
- The position requires extensive knowledge in the field of cell and gene therapy and applicable technologies, GMP and aseptic manufacturing, risk mitigation and process validation
- The position requires solid experience in interacting and collaborating with the clients and internal parties, including professional communication and transparency
- The position involves advanced supervisory tasks and involvement in recruitment, selection, coaching and training of MSAT staff.
- This function must be able to perform independently in her/his area of responsibility and is responsible for ensuring in time delivery of his/her area of supervision.
- This position requires experience in working in a fast paced environment and demonstrating professional response to unexpected events.
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.