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121201 F. Hoffmann-La Roche AG

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

Basel
VollzeitVor OrtSenior

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.

Anforderungen

  • 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

Aufgaben

  • 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

Berufserfahrung

  • 7 Jahre

Ausbildung

  • Bachelor-AbschlussODER
  • Master-Abschluss

Sprachen

  • Englischverhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 1201 F. Hoffmann-La Roche AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.

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