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 bonus
- 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 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)
- Advanced analytical and problem-solving skills
- Strong leadership and communication abilities
- Collaborative mindset across functions
- Upstream biologics manufacturing
- Mammalian cell culture (CHO)
- Single-use bioreactors
Upstream Biological Process, Lead Scientist datore di lavoro: Chiesi
Lavorare con noi significa essere parte di un team innovativo e dedicato, impegnato a trasformare la salute nelle malattie rare. Offriamo un ambiente di lavoro flessibile e collaborativo, con opportunità di crescita professionale e sviluppo delle competenze nel campo delle evidenze reali. I nostri dipendenti beneficiano di un programma di benessere completo, supporto per il trasferimento e opzioni di lavoro remoto, rendendo la nostra azienda un datore di lavoro eccezionale per chi cerca un impatto significativo nella sanità.
