Upstream Biological Process, Lead Scientist
Pubblicato il 15-10-2026 - Chiesi in Parma
Overview As a senior leader in Global TechOp&S;, you will drive the industrialization and lifecycle management of upstream biopharmaceutical processes. You will lead insourcing, technology transfer, scale-up and validation to ensure robust, scalable manufacturing from development to commercial production. You’ll coordinate across R&D;, CDMOs, Production, Quality and Engineering, applying QbD principles to meet global regulatory expectations. Your expertise will help shape biologics programs and enable continuous improvement in a dynamic, global setting. Retribuzione / Benefits * annual performance premio * pension * private medical insurance * wellbeing programme * flexible benefits programme * relocation support Responsabilità * Provide hands-on scientific and technical leadership in insourcing, transfer, scale-up and validation of biopharmaceutical processes. * Coordinate upstream process development, optimization and industrialization with internal R&D; and external CMOs. * Lead lifecycle management for commercial biotech processes, ensuring improvement, robustness,
compliance and supply reliability. * Interpret complex data to support decisions, risk mitigation, resources, and program strategy. * Apply QbD principles and contribute to process characterization, control strategies and validation plans. * Support regulatory submissions and represent CMC topics with health authorities. * Design, execute and evaluate pilot-scale studies to support development and transfer activities. * Collaborate with Production, Quality, Engineering and Maintenance for feasibility studies, validation campaigns and commercial implementation. * Support GMP documentation development (batch records, risk assessments, validation protocols, reports). * Provide technical expertise for investigations, deviations, changes controls and CAPAs. * Deliver training to Manufacturing personnel for compliant production processes. Requisiti fondamentali * MSc or PhD in Biotechnology, Biochemical Enginee