MSAT Process Specialists (m/f/d)
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.
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 Porriño team 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.
Perform Process Transfer, including supporting the pilot runs, creation of process transfer documents, review of the Batch records and supporting the designated Customer Project expert.
Represents Manufacturing Science and Technology (MSAT) on project teams as technical subject matter expert (SME) and interface with customer technical, as needed.
Authors/reviews/and owns process related documentation in collaboration with the Customer Project expert.
Authors/reviews process 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.
Participates and supports regulatory inspections and customer audits.
Lead the investigation of manufacturing deviations and investigations stand alone.
Perform other duties as assigned
Key requirements:
Minimum Masters/Bachelors in biological sciences/Biochemical engineering or equivalent field.
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
Availability for rotational on call shifts
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.