ITM Isotope Technologies Munich SE
Manager Production Projects(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
München, Neufahrn bei Freising
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ITITM Isotope Technologies Munich SE
GPMO Project Manager & CMC Lead(m/w/x)
Garching bei München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Defining and driving CMC strategy for radiopharmaceutical development and supply. GMP manufacturing technology and technology transfer experience required. Flexible working hours, home office options.
Anforderungen
- University degree in Life Science, Chemistry, Biology or Pharmacy
- Project management and team leadership experience
- Deep understanding of CMC information
- Professional GMP experience in manufacturing technology (liquids preferred)
- Professional experience in technology transfer
- Professional experience in strategic project management
- Professional experience in product management (pharmaceutical, radiopharmaceutical, medical technology)
- Practical experience in manufacturing or quality control advantageous
- Practical experience in regulatory affairs advantageous
- Practical experience in research & development advantageous
- Practical experience in radiation protection advantageous
- Pragmatic, solution-focused mindset
- Ability to present information clearly and structured
- Responsibility for milestone adherence
- Responsibility for budget adherence
- Flexibility
- Resilience
- Assertiveness
- High degree of organization skills
- High degree of communication skills
Aufgaben
- Define and drive CMC strategy aligned with program timelines, regulatory requirements, and business objectives
- Plan, coordinate, and execute all CMC activities from development through clinical supply to launch
- Ensure CMC activities are scientifically robust, compliant, and inspection-ready
- Manage highly visible interdisciplinary projects
- Lead and coordinate CMC workteam for pipeline projects
- Cover all CMC/IMP topics with the team and stakeholders
- Lead and coordinate team of SMEs
- Maintain overview in unclear situations
- Challenge quality, timelines, and budget
- Create project overviews, budget plans, and presentations
- Facilitate steering decisions
- Provide solutions in difficult situations
- Escalate deviations from the plan
- Manage CMC project budget
- Collaborate with finance
- Manage budget in SAP
- Lead technical transfers as project manager
- Strategically manage technology transfers of R&D
- Oversee and coordinate subprojects
- Align project plans according to resources and priority
- Work with matrix responsibility for interdisciplinary team
- Communicate with project team and external stakeholders
- Facilitate project documentation
- Report and follow up on project milestones
- Coordinate financial and resource requirements
- Mitigate risks
- Align project team on project goals
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – fließend
- Englisch – fließend
Benefits
Flexibles Arbeiten
- Flexible working hours
- Home office options
Weiterbildungsangebote
- Comprehensive onboarding programme
- Individually tailored further training programme
- German and English courses
Boni & Prämien
- Attractive special payments
Attraktive Vergütung
- Employee participation programme
Firmenfahrrad
- Job bike
Öffi Tickets
- Subsidised job ticket
Betriebliche Altersvorsorge
- Above-average contribution to company pension scheme
Gesundheits- & Fitnessangebote
- Health promotion programmes
- EGYM Wellpass
- Subsidy for local fitness studio
Gemeinnützige Ausrichtung
- Sponsorship of sporting events
Mentoring & Coaching
- Lifestyle coaching sessions
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ITM Isotope Technologies Munich SE 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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ITITM Isotope Technologies Munich SE
GPMO Project Manager & CMC Lead(m/w/x)
Garching bei München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Defining and driving CMC strategy for radiopharmaceutical development and supply. GMP manufacturing technology and technology transfer experience required. Flexible working hours, home office options.
Anforderungen
- University degree in Life Science, Chemistry, Biology or Pharmacy
- Project management and team leadership experience
- Deep understanding of CMC information
- Professional GMP experience in manufacturing technology (liquids preferred)
- Professional experience in technology transfer
- Professional experience in strategic project management
- Professional experience in product management (pharmaceutical, radiopharmaceutical, medical technology)
- Practical experience in manufacturing or quality control advantageous
- Practical experience in regulatory affairs advantageous
- Practical experience in research & development advantageous
- Practical experience in radiation protection advantageous
- Pragmatic, solution-focused mindset
- Ability to present information clearly and structured
- Responsibility for milestone adherence
- Responsibility for budget adherence
- Flexibility
- Resilience
- Assertiveness
- High degree of organization skills
- High degree of communication skills
Aufgaben
- Define and drive CMC strategy aligned with program timelines, regulatory requirements, and business objectives
- Plan, coordinate, and execute all CMC activities from development through clinical supply to launch
- Ensure CMC activities are scientifically robust, compliant, and inspection-ready
- Manage highly visible interdisciplinary projects
- Lead and coordinate CMC workteam for pipeline projects
- Cover all CMC/IMP topics with the team and stakeholders
- Lead and coordinate team of SMEs
- Maintain overview in unclear situations
- Challenge quality, timelines, and budget
- Create project overviews, budget plans, and presentations
- Facilitate steering decisions
- Provide solutions in difficult situations
- Escalate deviations from the plan
- Manage CMC project budget
- Collaborate with finance
- Manage budget in SAP
- Lead technical transfers as project manager
- Strategically manage technology transfers of R&D
- Oversee and coordinate subprojects
- Align project plans according to resources and priority
- Work with matrix responsibility for interdisciplinary team
- Communicate with project team and external stakeholders
- Facilitate project documentation
- Report and follow up on project milestones
- Coordinate financial and resource requirements
- Mitigate risks
- Align project team on project goals
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – fließend
- Englisch – fließend
Benefits
Flexibles Arbeiten
- Flexible working hours
- Home office options
Weiterbildungsangebote
- Comprehensive onboarding programme
- Individually tailored further training programme
- German and English courses
Boni & Prämien
- Attractive special payments
Attraktive Vergütung
- Employee participation programme
Firmenfahrrad
- Job bike
Öffi Tickets
- Subsidised job ticket
Betriebliche Altersvorsorge
- Above-average contribution to company pension scheme
Gesundheits- & Fitnessangebote
- Health promotion programmes
- EGYM Wellpass
- Subsidy for local fitness studio
Gemeinnützige Ausrichtung
- Sponsorship of sporting events
Mentoring & Coaching
- Lifestyle coaching sessions
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ITM Isotope Technologies Munich SE 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
ITM Isotope Technologies Munich SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt, produziert und vertreibt zielgerichtete diagnostische und therapeutische Radiopharmazeutika sowie Radioisotope für die Krebsbehandlung.
Noch nicht perfekt?
- ITM Isotope Technologies Munich SE
Manager Production Projects(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenMünchen, Neufahrn bei Freising - ITM Isotope Technologies Munich SE
Project Manager Quality Control(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGarching bei München - ITM Isotope Technologies Munich SE
Senior Manager, Early Development Regulatory Lead(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - Immatics Biotechnologies GmbH
Senior Clinical Operations Lead(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorMünchen - Siemens Healthineers
Quality Assurance Manager:in / Sachkundige Person(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenMünchen