Upstream Biological Process, Lead Scientist

Experteer Overview  As a senior leader in Global Tech Op&S, you will drive the industrialization and lifecycle management of upstream biopharmaceutical processes. You will lead in sourcing, 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 in sourcing, 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 background in biologics manufacturing and bioprocess development
Deep expertise in upstream process development and manufacturing (including mammalian cell culture, single‑use bioreactors, centrifugation, depth filtration)
Experience in process optimization, scale‑up/down, technology transfer and industrialization
Solid knowledge of GMP and global regulatory frameworks (FDA, EMA, ICH, CMC)
Experience supporting regulatory submissions and managing manufacturing in FDA‑ and EMA/AIFA‑approved facilities
Demonstrated ability to manage CDMO partnerships
Understanding of lifecycle management and commercialization strategies for biologics
English proficiency (written and spoken)
Requisiti fondamentali   annual performance bonus
pension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support

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