MSAT Process Expert
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.
Lonza Porriño is an integrated global contract manufacturing organization (CMO) offering a complete range of therapeutic protein manufacturing services. We have the ability to provide these services in a fully scalable manner and at every stage of the development process. Our capabilities include technology transfer, analytical development and testing, scale up and cGMP manufacturing and support services.
The MSAT Process Expert is assigned as the primary liaison to an external customer(s) for all technical-related items including Process transfer, Process monitoring, Validation and change controls, deviations, standalone investigations, CAPAs (Corrective and Preventative Action), and facilitates discussions between customers and internal groups.
- Manage Customer projects for the entire lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals.
- Lead Joint Technical Team meetings –establishes agendas, publishes meeting minutes and tracks action items; participates in Internal and Joint Project Team (IPT/JPT) meetings as the MSAT representative.
- Secure success during technology transfer by applying formal processes and tools to manage the transfer of information, process related risks and change control.
- Supports the Deviation, Change Request and CAPA processes specific to their assigned customers; writes, reviews and approves investigation reports as required.
- Represents department at site meetings (e.g. Deviation and Run Daily Management System meetings).
- Supports Customer audits and Regulatory inspections.
- Bachelor’s Degree or equivalent experience. Preferred area of study: Scientific related field. Biotechnology manufacturing background is preferred.
- Significant experience in MSAT or similar discipline, within biologics, biotechnology, pharmaceutical or clinical environment. Substantial experience in GMP (Good Manufacturing Practices) environment.
- Project Management Skills, including Presentations, Customer Liaison, Meeting facilitation, effective Planning, Organizing and Controlling competency. Experience in leading cross-functional project teams.
- Experience with Data base management and statistical tools, LIMS, Trackwise and Microsoft Suite preferred.
- Fluency in English and Spanish.
- Green belt certificated preferred.
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.