Lonza
Senior Director, Global Head MSAT, Advanced Synthesis(m/w/x)
Vollzeitnur vor OrtSenior
Basel
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ARARTBIO
Director, MSAT Operations(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
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
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
Berufserfahrung
- 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- automated synthesis modules
- hot cells
- batch record systems
- Lean Six Sigma
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.
Noch nicht perfekt?
- Novartis Pharma AG
Isotope Project Lead (Associate Director S&T)(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Global MSAT Senior Product & Process Steward(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Lonza
Senior Director, Global Head Transformation Advanced Synthesis(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Global MSAT Senior Analytical Steward(m/w/x)
Vollzeitnur vor OrtSeniorBasel
ARARTBIO
Director, MSAT Operations(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
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
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
Berufserfahrung
- 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- automated synthesis modules
- hot cells
- batch record systems
- Lean Six Sigma
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.
Über das Unternehmen
ARTBIO
Branche
Pharmaceuticals
Beschreibung
ARTBIO redefines cancer care by developing Alpha Radioligand Therapies (ARTs) using Pb-212 isotope technology for high efficacy and safety.
Noch nicht perfekt?
- Lonza
Senior Director, Global Head MSAT, Advanced Synthesis(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Novartis Pharma AG
Isotope Project Lead (Associate Director S&T)(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Global MSAT Senior Product & Process Steward(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Lonza
Senior Director, Global Head Transformation Advanced Synthesis(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Global MSAT Senior Analytical Steward(m/w/x)
Vollzeitnur vor OrtSeniorBasel