Position TitlePrincipal Scientist - Functional Lead, Upstream Process Development
Job DescriptionIn this position you will lead a Upstream team (scientists and associates) in the development of upstream processes of a wide diversity of protein pharmaceuticals for phase III clinical studies to market supply.
• Using your experience in the development of cell culture, you are responsible for the development of cell culture processes as well as supporting activities related to process transfer to large scale, process characterization and validation. • You autonomously plan, supervise, evaluate experiments to arrive at scientifically sound conclusions and well-supported recommendations and write reports for the development and optimization of processes, using cell culture sciences as well as statistical design (DOE), while making optimal use of available resources and time. • You ensure timely execution of assigned work packages according to agreed project plans, actively communicate with department and project management, accurately deliver documents and maintain the scientific and technical state of the art of your unit. • The proteins of interest are pharmaceuticals comprising antibodies and other constructs expressed by mammalian systems. • You support technology and upstream process transfers to manufacturing sites within the Novartis organization and to CMOs • You actively contribute to project teams as USP expert and organize subteam meetings, if required
Minimum requirementsExcellent knowledge of English, both written and spoken PhD or equivalent degree in Biochemical Engineering, Biology or related discipline or equivalent professional experience in an industrial setting. 3 – 5 years of related experience in industry, or equivalent exposure in academia.
Experience: - Experience in Upstream, especially in mammalian cell culture is essential. We are looking for > 5 years of experience in process development or a related role in an industrial setting. - Experience with technical and operational aspects of large-scale cultivation equipment is required; experience in late-stage (Phase III clinical and commercial supply) upstream process development/characterization/validation, harvest (centrifugation, depth and membrane filtration) and regulatory filings would be an asset. - Familiarity with state-of-the-art experimental design approaches to support process optimization is advantageous, as is experience in the use of high-throughput technology for the development of cell culture processes. - Further requirements include a team player with strong communication, established presentation and scientific/technical writing skills, good management skills with respect to planning, tracking, priority setting and adherence to project timelines.