Upstream Biological Process, Lead Scientist

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

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