Lead Scientist, Upstream Biological Process

• Providing hands‑on scientific and technical leadership in process insourcing, technology transfer, scale‑up, and validation activities
• Coordinating upstream process development, optimization, and industrialization activities with internal R&D teams and external CMOs
• Leading lifecycle management activities for commercial biotech processes, ensuring continuous improvement, process robustness, compliance, and supply reliability
• Assessing and interpreting complex scientific data to support decision‑making, risk mitigation, resource allocation, and program strategy
• Applying and promoting Quality by Design (QbD) principles and contributing to process characterization, control strategies, and validation plans
• Supporting regulatory submissions (MAA, NDA, BLA, JNDA)
• Designing, executing, and evaluating pilot‑scale studies to support process development, optimization, scale‑up, and technology transfer activities
• Collaborating with Production, Quality, Engineering, and Maintenance functions to support feasibility studies, validation campaigns, equipment qualification (IQ/OQ/PQ), and commercial process implementation
• Supporting the development of GMP documentation, including batch records, risk assessments, validation protocols, and technical reports
• Delivering theoretical and practical training to Manufacturing personnel

Requirements

• MSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry, or a related discipline
• At least 10 years of experience in biopharmaceutical drug substance process development
• Strong scientific background in biologics manufacturing and bioprocess development
• Deep expertise in upstream process development and manufacturing, including mammalian cell culture (preferably CHO), single‑use bioreactors, centrifugation, and depth filtration
• Proven experience in process optimization, scale‑up/down activities, technology transfer, and industrialization of biotechnological products
• Solid knowledge of GMP requirements and global regulatory frameworks, including FDA, EMA, ICH, and CMC guidelines
• Experience supporting regulatory submissions and managing manufacturing processes in FDA‑ and EMA/AIFA‑approved facilities
• Demonstrated ability to manage CDMO partnerships and external development activities
• Strong understanding of product lifecycle management and commercialization strategies for biologics
• Good knowledge of English (written and spoken)