MSAT Technical Lead - Drug Substance - Biologics

At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases. As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo. We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development. Science and Technology (SAT) is part of the Global CMC, Science & Technology Department (GCSAT). GCSAT is a growing organization, responsible for optimization and life cycle management of Sobi’s clinical and commercial manufacturing and analytical processes in our external network. SAT ensures compliant, reliable, cost effective and sustainable manufacturing and testing of our products now and in future. The SAT team holds the senior scientific and technical knowledge for the manufacturing and analytical testing of Sobi’s clinical and commercial products and is responsible for always keeping processes in a validated stage. The Technical Lead is pivotal in ensuring technical excellence, regulatory compliance, and the continuous improvement of manufacturing processes. The incumbent will drive cross-functional collaboration to support the launch and lifecycle management of products, technology transfers, and the implementation of innovative methodologies Main responsibilities: Subject matter expert (SME) for DS Biologics manufacturing. Process owner of DS Biologics validation for Sobi products. Lead and execute MSAT projects such as manufacturing process and cost improvement as part of life-cycle management (LCM). Participate in and lead internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs. Issue, review and approve applicable internal and external SOP’s and manufacturing instructions. Review and supervise set up, execution and documentation