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ARTBIO
3h ago

Director, MSAT Operations(m/w/x)

Basel
Full-timeOn-siteSenior

Description

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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Requirements

  • 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

Education

Master's degree

Work Experience

8 years

Tasks

  • 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 & Technologies

automated synthesis moduleshot cellsbatch record systemsLean Six Sigma

Languages

EnglishBusiness Fluent

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