BioTalent are partnered with a global leader in Biosimilars based within Vaud, to support the hire of a Senior Manager with expertise in DSP who will define and lead biologics development projects for the downstream team.

This role will offer you:

• The chance to oversee and manage a range of biologics development projects, working closely with external manufacturing partners, process design and acting as an technical expert in a leadership function.

You will be responsible for:

• Utilising QbD principles to define technical development in line with regulatory requirements, timelines and costs whilst providing SME support for in-house DSP activities.
• Lead the design and execution of technology transfers, defining characterisation and validation activities.
• Manage external manufacturing suppliers for DSP production including the management and authoring and review of CMC documentation, root-cause investigation activities, and troubleshooting downstream processes.
• Ensure project delivery through the leadership and management of a team of scientists across multiple concurrent projects, providing expertise on purification development for the isolation of biologics

You will bring the following:

• A Bachelors or higher level of academic education in a relevant subject e.g. Biochemical Engineering, Biotechnology, Bioprocessing
• Proven industrial experience within a biologics drug substance development environment covering process development, scale-up and process transfer, with expertise in downstream development utilising mammalian cell systems.
• Previous success in technical leadership within a dynamic DSP development environment.

BioTalent Ltd are acting as an employment agency in relation to this opportunity. Please reach out to Jogesh.Bowry@biotalent.com if you have any initial queries.