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AR
ARTBIO
vor 1 Std.

Director, MSAT Operations(m/w/x)

Basel
VollzeitVor OrtSenior

Beschreibung

You will lead the global industrialization of radiopharmaceutical production, bridging the gap between R&D and commercial manufacturing while overseeing complex facility builds and technical transfers.

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Anforderungen

  • Advanced degree in related field
  • Experience in radiopharmaceutical manufacturing
  • Expertise in GMP production
  • Understanding of regulatory frameworks
  • Experience with automated synthesis modules
  • Strong leadership and project management
  • Experience with CDMO tech transfers
  • Familiarity with radiopharmaceutical digital tools
  • Radiation safety certification or training
  • Lean Six Sigma or similar certification
  • Teamwork skills and autonomy
  • Ability to lead cross-functional teams
  • Strong communication and technical writing
  • Ability to operate globally
  • Fluency in English

Ausbildung

Master-Abschluss

Berufserfahrung

8 Jahre

Aufgaben

  • Direct all CDMO product and process transfers
  • Lead scale-up and industrialization activities
  • Liaise between internal and external technical functions
  • Scale complex radiolabeling and aseptic filling operations
  • Lead transitions to commercial readiness and expansion
  • Oversee technical aspects of new production lines
  • Ensure facility compliance with radiation safety standards
  • Transfer radiopharmaceutical processes into GMP manufacturing
  • Develop and execute technical transfer plans
  • Define optimized and robust manufacturing processes
  • Monitor and trend process KPI performance
  • Collect customer feedback to trigger operational improvements
  • Support final drug product supply chains
  • Collaborate with quality and regulatory affairs teams
  • Support regulatory submissions with technical documentation
  • Provide scientific support for isotope manufacturing
  • Oversee change control during technology transfers
  • Resolve technical transfer project issues with stakeholders
  • Lead radiopharmaceutical facility builds and expansions
  • Define URS and oversee equipment qualification
  • Manage radioactive material handling and waste systems
  • Ensure predictable and accurate product unit costs
  • Partner with vendors to deliver compliant infrastructure
  • Lead cross-functional teams across global sites
  • Collaborate with R&D to expand operations
  • Mentor staff to build technical capabilities

Tools & Technologien

automated synthesis moduleshot cellsbatch record systemsLean Six Sigma

Sprachen

Englischverhandlungssicher

Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ARTBIO 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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