ITM Isotope Technologies Munich SE
Medical Affairs Manager(m/w/x)
Full-timeWith HomeofficeExperienced
Garching bei München
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ITITM Isotope Technologies Munich SE
GPMO Project Manager & CMC Lead(m/w/x)
Garching bei München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Defining and driving program strategy for targeted radiopharmaceuticals in cancer treatment. Multiple years GMP experience in manufacturing technology for radiopharmaceuticals required. Attractive special payments.
Requirements
- 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)
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Flexible Working
- Hybrid working model
- Flexible working hours
- Home office options
Learning & Development
- Comprehensive onboarding program
- Tailored further training program
- German courses
- English courses
Bonuses & Incentives
- Attractive special payments
Competitive Pay
- Employee participation program
Company Bike
- Job bike
Public Transport Subsidies
- Subsidized job ticket
Retirement Plans
- Above-average company pension contribution
Healthcare & Fitness
- Health promotion programs
- EGYM Wellpass
- Fitness studio subsidy
Team Events
- Sporting event sponsorship
Mentorship & Coaching
- Lifestyle coaching sessions
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ITM Isotope Technologies Munich SE 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.
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ITITM Isotope Technologies Munich SE
GPMO Project Manager & CMC Lead(m/w/x)
Garching bei München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Defining and driving program strategy for targeted radiopharmaceuticals in cancer treatment. Multiple years GMP experience in manufacturing technology for radiopharmaceuticals required. Attractive special payments.
Requirements
- 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)
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Flexible Working
- Hybrid working model
- Flexible working hours
- Home office options
Learning & Development
- Comprehensive onboarding program
- Tailored further training program
- German courses
- English courses
Bonuses & Incentives
- Attractive special payments
Competitive Pay
- Employee participation program
Company Bike
- Job bike
Public Transport Subsidies
- Subsidized job ticket
Retirement Plans
- Above-average company pension contribution
Healthcare & Fitness
- Health promotion programs
- EGYM Wellpass
- Fitness studio subsidy
Team Events
- Sporting event sponsorship
Mentorship & Coaching
- Lifestyle coaching sessions
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ITM Isotope Technologies Munich SE 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
ITM Isotope Technologies Munich SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt, produziert und vertreibt zielgerichtete diagnostische und therapeutische Radiopharmazeutika sowie Radioisotope für die Krebsbehandlung.
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