Experteer 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 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.
Responsabilità MSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry or related discipline
At least 10 years in biopharmaceutical drug substance process development with leadership in complex biologics CMC programs
Strong bac

📌 Upstream Biological Process, Lead Scientist (Italia)
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📍 Italia