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121201 F. Hoffmann-La Roche AG

Global MSAT DS Senior Process Steward(m/w/x)

Basel
Full-timeOn-siteSenior

Process industrialization, gap assessments, and risk mitigation for biopharmaceutical product technical leads. 7+ years industrial experience in process development or manufacturing operations required; PhD advantageous. Work in a large biopharmaceutical organization with 100,000+ employees.

Requirements

  • B.S. or M.S. degree in Chemical, Biochemical Engineering, or related discipline
  • 7+ years of relevant industrial experience in process development, process engineering, or manufacturing operations
  • PhD is advantageous
  • Experience in collaborative, matrix team leadership and decision-making
  • Demonstrated experience in process engineering, technical process development, process validation, or technology transfer
  • Experience with E. coli & CHO processes
  • Familiarity with pharmaceutical quality systems, industry guidelines, regulatory submission, health authority requirements, and platform-specific technology
  • Advanced verbal and written communication skills
  • Willingness to travel less than 10% as required

Tasks

  • Support Product Technical Leads and Product Stewards in process industrialization
  • Coordinate and execute process gap assessments
  • Integrate identified risks into the risk log
  • Develop mitigation strategies for risks
  • Drive systematic process improvements based on insights
  • Implement second source and change strategies
  • Execute validated state support activities
  • Respond to evolving conditions to ensure compliance
  • Provide technical expertise for engineering runs
  • Offer hands-on support for investigations and troubleshooting
  • Lead non-product specific root cause analyses and investigations
  • Leverage pilot plant team for scaled experimentation
  • Support validation studies and process transfer to manufacturing sites
  • Ensure implementation of network initiatives aligned with manufacturing plans
  • Incorporate portfolio-wide aspects like material changes and Health Authority requirements
  • Collaborate with global and site functions and leadership
  • Translate business needs to digital strategy and product development teams
  • Drive technical sustainability improvements for product, process, and technology

Work Experience

  • 7 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent
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