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ITITM Isotope Technologies Munich SE

GPMO Project Manager & CMC Lead(m/w/x)

Garching bei München
Vollzeitmit HomeofficeSenior

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

  • Deutschverhandlungssicher
  • Englischverhandlungssicher

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
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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