Lonza
Senior Director, Global Head MSAT, Advanced Synthesis(m/w/x)
Full-timeOn-siteSenior
Basel
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Directing CDMO transfers and scaling complex Pb-212 radiolabeling and aseptic filling for Alpha Radioligand Therapies. Radiopharmaceutical manufacturing and automated synthesis module experience required. Focus on developing novel Alpha Radioligand Therapies.
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
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
Work Experience
- 8 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- automated synthesis modules
- hot cells
- batch record systems
- Lean Six Sigma
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ARTBIO and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- Novartis Pharma AG
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Directing CDMO transfers and scaling complex Pb-212 radiolabeling and aseptic filling for Alpha Radioligand Therapies. Radiopharmaceutical manufacturing and automated synthesis module experience required. Focus on developing novel Alpha Radioligand Therapies.
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
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
Work Experience
- 8 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- automated synthesis modules
- hot cells
- batch record systems
- Lean Six Sigma
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ARTBIO and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
ARTBIO
Industry
Pharmaceuticals
Description
ARTBIO redefines cancer care by developing Alpha Radioligand Therapies (ARTs) using Pb-212 isotope technology for high efficacy and safety.
Not a perfect match?
- Lonza
Senior Director, Global Head MSAT, Advanced Synthesis(m/w/x)
Full-timeOn-siteSeniorBasel - Novartis Pharma AG
Isotope Project Lead (Associate Director S&T)(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Global MSAT Senior Product & Process Steward(m/w/x)
Full-timeOn-siteSeniorBasel - Lonza
Senior Director, Global Head Transformation Advanced Synthesis(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Global MSAT Senior Analytical Steward(m/w/x)
Full-timeOn-siteSeniorBasel