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GPMO Project Manager & CMC Lead(m/w/x)
Defining and driving program strategy for targeted radiopharmaceuticals in cancer treatment. Multiple years GMP experience in manufacturing technology for radiopharmaceuticals required. Attractive special payments.
Anforderungen
- University Degree (preferably Life Science, Chemistry, Biology, or Pharmacy)
- Demonstrated project management, team leadership, and CMC information understanding
- Multiple years GMP experience in manufacturing technology (liquids preferred), technology transfer, strategic project management, and product management (pharmaceutical, radiopharmaceutical, or medical technology industry)
- Advantageous: Practical experience in manufacturing, quality control, regulatory affairs, R&D, or radiation protection
- Pragmatic, solution-focused mindset; structured information presentation ability
- Responsibility for milestone and budget adherence
- Flexibility, resilience, assertiveness, high organization, and communication skills
- Willingness to travel internationally (max. 20%)
- Fluent German and English (written and spoken)
Aufgaben
- Define program CMC strategy
- Drive program CMC strategy
- Ensure strategy aligns with timelines
- Ensure strategy meets regulatory requirements
- Ensure strategy supports business objectives
- Plan CMC activities from development to launch
- Coordinate CMC activities from development to launch
- Execute CMC activities from development to launch
- Ensure CMC activities are robust, compliant, and inspection-ready
- Coordinate robust, compliant, and inspection-ready CMC activities
- Collaborate with team and stakeholders on CMC/IMP topics
- Lead and coordinate your team of SMEs
- Connect disparate information
- Maintain overview in unclear situations
- Challenge quality, timelines, and budget
- Create project oversight documents
- Develop project plans
- Develop budget plans
- Prepare presentations
- Trigger steering decisions
- Facilitate steering decisions
- Provide team solutions in difficult situations
- Escalate deviations from the plan
- Manage CMC project budget
- Collaborate closely with finance
- Manage project budget in SAP
- Lead technology transfers
- Manage oversight of subprojects
- Coordinate various subprojects
- Align project plans according to resources and priority
- Collaborate with interdisciplinary matrix teams
- Communicate with project team members
- Communicate with internal stakeholders
- Communicate with external stakeholders
- Facilitate project documentation
- Report on project milestones
- Follow up on project milestones
- Coordinate financial requirements
- Coordinate resource requirements
- Mitigate project risks
- Align project team on project goals
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Hybrid working model
- Flexible working hours
- Home office options
Weiterbildungsangebote
- Comprehensive onboarding program
- Tailored further training program
- German courses
- English courses
Boni & Prämien
- Attractive special payments
Attraktive Vergütung
- Employee participation program
Firmenfahrrad
- Job bike
Öffi Tickets
- Subsidized job ticket
Betriebliche Altersvorsorge
- Above-average company pension contribution
Gesundheits- & Fitnessangebote
- Health promotion programs
- EGYM Wellpass
- Fitness studio subsidy
Team Events & Ausflüge
- Sporting event sponsorship
Mentoring & Coaching
- Lifestyle coaching sessions
Noch nicht perfekt?
- ITM Isotope Technologies Munich SEVollzeitmit HomeofficeBerufserfahrenGarching bei München
- ITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - ITM Isotope Technologies Munich SE
Head of Market Intelligence(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - 0044 BMS GmbH&Co.KGaA Germany
Senior Brand Manager, Oncology(m/w/x)
Vollzeitmit HomeofficeManagementMünchen
GPMO Project Manager & CMC Lead(m/w/x)
Defining and driving program strategy for targeted radiopharmaceuticals in cancer treatment. Multiple years GMP experience in manufacturing technology for radiopharmaceuticals required. Attractive special payments.
Anforderungen
- University Degree (preferably Life Science, Chemistry, Biology, or Pharmacy)
- Demonstrated project management, team leadership, and CMC information understanding
- Multiple years GMP experience in manufacturing technology (liquids preferred), technology transfer, strategic project management, and product management (pharmaceutical, radiopharmaceutical, or medical technology industry)
- Advantageous: Practical experience in manufacturing, quality control, regulatory affairs, R&D, or radiation protection
- Pragmatic, solution-focused mindset; structured information presentation ability
- Responsibility for milestone and budget adherence
- Flexibility, resilience, assertiveness, high organization, and communication skills
- Willingness to travel internationally (max. 20%)
- Fluent German and English (written and spoken)
Aufgaben
- Define program CMC strategy
- Drive program CMC strategy
- Ensure strategy aligns with timelines
- Ensure strategy meets regulatory requirements
- Ensure strategy supports business objectives
- Plan CMC activities from development to launch
- Coordinate CMC activities from development to launch
- Execute CMC activities from development to launch
- Ensure CMC activities are robust, compliant, and inspection-ready
- Coordinate robust, compliant, and inspection-ready CMC activities
- Collaborate with team and stakeholders on CMC/IMP topics
- Lead and coordinate your team of SMEs
- Connect disparate information
- Maintain overview in unclear situations
- Challenge quality, timelines, and budget
- Create project oversight documents
- Develop project plans
- Develop budget plans
- Prepare presentations
- Trigger steering decisions
- Facilitate steering decisions
- Provide team solutions in difficult situations
- Escalate deviations from the plan
- Manage CMC project budget
- Collaborate closely with finance
- Manage project budget in SAP
- Lead technology transfers
- Manage oversight of subprojects
- Coordinate various subprojects
- Align project plans according to resources and priority
- Collaborate with interdisciplinary matrix teams
- Communicate with project team members
- Communicate with internal stakeholders
- Communicate with external stakeholders
- Facilitate project documentation
- Report on project milestones
- Follow up on project milestones
- Coordinate financial requirements
- Coordinate resource requirements
- Mitigate project risks
- Align project team on project goals
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Hybrid working model
- Flexible working hours
- Home office options
Weiterbildungsangebote
- Comprehensive onboarding program
- Tailored further training program
- German courses
- English courses
Boni & Prämien
- Attractive special payments
Attraktive Vergütung
- Employee participation program
Firmenfahrrad
- Job bike
Öffi Tickets
- Subsidized job ticket
Betriebliche Altersvorsorge
- Above-average company pension contribution
Gesundheits- & Fitnessangebote
- Health promotion programs
- EGYM Wellpass
- Fitness studio subsidy
Team Events & Ausflüge
- Sporting event sponsorship
Mentoring & Coaching
- Lifestyle coaching sessions
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
Medical Affairs Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGarching bei München - ITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - ITM Isotope Technologies Munich SE
Head of Market Intelligence(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - 0044 BMS GmbH&Co.KGaA Germany
Senior Brand Manager, Oncology(m/w/x)
Vollzeitmit HomeofficeManagementMünchen