Upstream Biological Process, Lead Scientist

1 giorno fa

Reggio nell'Emilia, Emilia-Romagna, Italia Chiesi Tempo pieno

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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

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Upstream Biological Process, Lead Scientist

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