85 days ago on career012.successfactors.eu

USP Process Development Scientist

Merck Gruppe

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 Please refer to JobSuchmaschine in your application

USP Process Development Scientist

Your role:

Within the Biotech Process Sciences department, drive projects of process development or process validation of monoclonal antibodies or fusion-proteins production using mammalian cells

Drive project execution according to timelines given by the global project team

Design fit-for-purpose cell culture experiments according to the stage of development and using QbD concepts

Prepare validation protocols to ensure proper execution of cell culture experiments within a defined quality framework

Ensure scientific evaluation of impact of deviations to upstream validation studies

Compile and analyze experimental data to generate process knowledge and decide on next steps

Write development and validation reports and ensure their timely delivery

Prepare and present project updates to global project team and to upper management

Act as the project focal point for the department for all others functions involved


Who you are

• Engineering/Master degree (PhD preferred) in biotechnology with 3-6 years in the biopharmaceutical industry

• Hands-on experience in process development and manufacturing of monoclonal antibodies. Knowledge of quality attributes of glyco-proteins a must.

• Hands-on experience in process validation and QbD concepts

• Quality mindset and good understanding of Good Manufacturing Practices

• Excellent presentation and communication skills

• Results-oriented with ability to work and deliver under pressure

• Excellent English (written, oral)

• Fluency in French (oral) appreciated