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Senior Manager USP Development
- Posted 17 February 2023
- Job type Permanent
- DisciplineBioprocessing & MSAT
- Contact NameJogesh Bowry
BioTalent are partnered with a global leader in Biosimilars based within Vaud, to support the hire of a Senior Manager with expertise in USP who will define and lead biologics development projects for the upstream 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 USP activities.
- Lead the design and execution of technology transfers, defining characterisation and validation activities.
- Manage external manufacturing suppliers for USP production including the management and authoring and review of CMC documentation, root-cause investigation activities, and troubleshooting upstream processes.
- Ensure project delivery through the leadership and management of a team of scientists across multiple concurrent projects, providing expertise on mammalian expression of biologics using advanced bioreactor systems.
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 upstream development utilising mammalian cell systems.
- Previous success in technical leadership within a dynamic USP 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.