SUMMARY
The upstream Scientist/Process Scientist/Engineer MT is responsible for supporting usptream technology transfer and routine commercial or clinical manufacturing at Yverdon Bioplant. The upstream SME will play a key role supporting process documentation establishment participating in plant modeling and facility fit assessment to define process descriptions and other process deliverables. The upstream SME will contribute to deviation investigations and change controls when appropriate. This will include process data analysis developing tools to support batch reporting and troubleshooting, as well as writing tech transfer or campaign reports
DUTIES AND RESPONSABILITIES
Main responsibilities are below
- Support clinical campaign and Tech Transfer (TT) of new processes to the Yverdon Manufacturing facility as upstream SME
- Serve as Upstream Subject Matter Expert (SME) and provide upstream process expertise to the production
- Issue upstream tech transfer documentation (eg process description, sampling plan, protocols)
- Support all other departments in system set ups linked to TT (QC, automation, supply, etc.)
- Support Manufacturing to process, process improvement, protocols etc.
- Coordinate sampling plans with Manufacturing and Quality Control
- Support Manufacturing in troubleshooting
- Support and review MES definition to match process descriptions.
- Writing and reviewing protocols, summary reports, and campaign reports when required.
- Develop or support development of process data analysis and visualization tools
- Operational and decision‐making referent in her/his field of activity
- Support and use of a plant model that allows to simulate of process improvements to increase capacity, or reduce Cost of Goods.
- Ensure tech transfer batches/engineering runs are supported and executed according to protocols in coordination with production.
- Closely follow day to day Manufacturing activities during TT runs including process parameters, hold times and IPC tracking
- Closely collaborate with Manufacturing Process owners (internal as well as external)
- Closely collaborate with external partners for the scouting and implementation of new technologies
- Close Interactions with the Global Process Science in both Yverdon and USA
- Support routine commercial manufacturing activities including: Support update of process documentation
- Support process deviations and change controls
- Support the definition of User Systems Requirements (URS) for new upstream equipment required in the Bioplant
- Represent MT in participating in risk assessments in collaboration with other areas (BioProcess Science and Production)
- Contribute to the writing and review of process validation protocols and reports (production and laboratory)
- Support the execution of upstream process validation protocols in production
- As SME, provide support during Heath Authorities inspection by presenting commissioning and qualification dossiers as well as RA, Deviations, Investigations, CCP and CAPAs
REQUIREMENTS
- Biotechnology, engineering or pharmaceutical MSc degree preferred (e.g. Swiss HES, University, Engineering School) and relevant experience in the biotech industry
- Demonstrated practical experience of USP equipment– typically 2-5 years
- French and English (Fluent)
- Ability to work in a fast paced – highly regulated environment, high pressure and fast response
- Team work oriented mindset
- Contribute positively to a strong culture of business integrity and ethics
- Act within compliance and legal requirements as well as within company guidelines
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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