MSAT protein purification SME / Senior process Scientist Downstream

  • Incyte Corporation
  • Yverdon-les-Bains, VD, Switzerland
  • 10/07/2020
Full time Data Science Data Analytics Big Data Statistics

Job Description

Job Summary (Primary function)

During the construction and facility startup phase, the MSAT DSP SME/Senior Scientist will support the commissioning and qualification of downstream laboratory equipment and the implementation of the purification process at laboratory scale. This may include Äktas, IEX chromatography, depth filtration, viral inactivation, viral filtration, SPTFF and UFDF.

Once in operation mode, the DSP SME/Senior Scientist will be responsible for defining experimental designs in context of process characterization, technology transfer and the development of qualified downscale models at laboratory scale, in collaboration with the MSAT team. The DSP Senior Scientist will bring protein purification expertise during Technology Transfer and routine production at commercial scale.

Essential Functions of the Job (Key responsibilities)

During the laboratory start-up phase, you will mainly:

  • Provide protein purification scientific expertise to MSAT laboratory and Manufacturing.
  • Author/ Review downstream laboratory standard operating procedures or work instructions necessary before the laboratory equipment qualification or the operational phase.
  • Support the qualification of purification and support equipment in the MSAT laboratory.
  • Develop the implementation of the purification process and support the implementation of ELN in the MSAT laboratory.
  • Lead Risk Assessments for MSAT downstream equipment and support risk assessment in other areas (upstream MSAT, Manufacturing).
  • Work closely with the Process Development team in the USA.
  • Ensure that all MSAT downstream equipment are appropriately qualified and fit for purpose for development of downscale models and support to production.

During the Tech Transfer and operational phases, you will mainly:

  • Be responsible for defining the downstream experimental designs or Design of Experiments (DOEs) in the context of process characterizations, process optimization and investigations.
  • Lead the implementation of the downstream process at laboratory scale.
  • Support the writing or review of laboratory protocols and summary reports.
  • Contribute to the execution of experiments at laboratory scale.
  • Lead downstream downscale models development and qualification.
  • Propose initiatives for process optimization or yield improvement.
  • Lead downstream process risk assessment in the MSAT laboratory and support to production DSP process risk assessment.
  • Represent MSAT as protein purification expert during Tech Transfers.
  • During routine production, provide purification scientific expertise and support to Manufacturing (process events, troubleshooting or investigations).
  • Act as a mentor to more junior team members and lead by example to ensure timely completion of laboratory objectives and proactively propose problem resolution

Qualifications (Minimal acceptable level of education, work experience, and competency)

  • PhD degree (preferred) or Master degree from an Engineering school or University with relevant experience in a biotech or pharmaceutical environment.
  • 5 to 10 years’ experience at laboratory scale, process development or manufacturing scale
  • Expert in protein purification
  • Basic statistical knowledge (i.e. six sigma green belt training) and/or experience in the definition of Design of Experiments (DOEs) preferred
  • French and English (Fluent)
  • Ability to work in a fast paced – highly regulated environment
  • 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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