Msat Process Specialits

Spain, PorrinoToday, 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 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 Specialist is responsible of the execution of activities related to support technical / scientific of biotechnology products production, to ensure product quality and satisfactory release of the batches produced. Perform technology transfers of new products and make them a reality within the Porriño facilities in collaboration with other teams and the customers.

**Key Responsibilities**:

- Perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary, perform activities for lot release (assess deviations and process changes), and support continued process verification activities and PQR generation.
- Authors/reviews/and owns process related documentation and change controls (including managing the implementation of the change as the assigned change agent) when it is applicable in collaboration with the Customer Project expert.
- Performs all MSAT functions associated with manufacturing process support.
- Represent the Porriño MSAT function via the global technical operations network, ensuring knowledge sharing and constant compliance to global procedures at all times and participates and supports regulatory inspections and customer audits.
- Lead the investigation of manufacturing deviations and investigations stand alone and perform other duties as assigned.

**Key Requirements**:

- Bachelor’s Degree or equivalent experience. Preferred area of study: Scientific related field. Biotechnology manufacturing background is preferred.
- Advanced years' experience in laboratory or manufacturing scale operations in biopharmaceutical development technology transfer of manufacturing environments.
- Knowledge in mammalian cell Upstream and Downstream process essential and aware of current regulatory and industry standards and GMP guidance.
- Experience with Data base management and statistical tools, LIMS, Trackwise and Microsoft Suite preferred.
- Fluency in English and Spanish.

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.
- Reference: R60663