Upstream Biological Process, Lead Scientist
Pubblicato il 04-10-2026 - Chiesi in Italia
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 Engin