ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).
We would like to fill the following permanent vacancy in hybrid working model in Garching as soon as possible
GPMO Project Manager & CMC Lead (f/m/d)
Your role
* Define and drive the program 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 and coordinate CMC activities to be scientifically robust, compliant, and inspection-ready
* Project Management expert for highly visible interdisciplinary projects
* In a function as Workteam Lead CMC for our pipeline projects you cover all CMC / IMP (Investigational Medicinal Product) topics together with your team and different stakeholders
* You will lead and coordinate your team of SMEs and connect the dots, keep the overview also in unclear situations, and continuously challenge quality, timelines and budget
* Create oversights, project and budget plans, presentations
* Trigger and facilitate steering decisions, provide with the team solutions in difficult situations, escalate deviations from the plan
* Responsible for CMC project budget, strong collaboration with finance, manage budget in SAP
* Lead necessary Tec Transfers as responsible project manager. Inhabit a strategic and cross-functional key position for the technical project management and technology transfers of e.g. R&D
* Managing the oversight and coordination of different subprojects, aligning different project plans according to resources and priority
* Work with matrix responsibility for an interdisciplinary team including Business Leadership, Quality Assurance, Quality Control, Supply Chain, Finance, IT, Validation, Manufacturing, Regulatory Affairs, Engineering and CAPEX Management
* Communicate within the project team, internal and external stakeholders, facilitate adequate project documentation, report and follow-up on project milestones, coordinate financial and resource requirements, mitigate risks and align the project team on the project goal
Your profile
* University Degree preferably in Life Science, Chemistry, Biology or Pharmacy
* Demonstrated experience in project management and leading team and deep understanding of CMC information
* Multiple years of professional GMP experience in manufacturing technology (liquids preferred), technology transfer, strategic project management and product management of a pharmaceutical, radiopharmaceutical or medical technology industry
* Further practical experience in the field manufacturing or quality control, regulatory affairs, research & development, or radiation protection advantageous
* Pragmatic, solution focused mindset and ability to clearly present information in a structured way
* Taking responsibility for milestone and budget adherence
* Flexibility, resilience, assertiveness and a high degree of organization and communication skills
* Willingness to travel internationally (max. 20%)
* Fluent in German and English, both written and spoken
Our offer
* Exciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedom
* An open working atmosphere in an international corporate culture with short communication channels
* Comprehensive onboarding programme
* Flexible working hours with home office options
* Attractive special payments
* Just a good salary? Not with us! We also offer you
o Employee participation programme
o Job bike or subsidised job ticket
o Above-average contribution to the company pension scheme
o Individually tailored further training programme (including German and English courses)
o Health promotion programmes (e.g. EGYM Wellpass, subsidy for local fitness studio, sponsorship of sporting events, various lifestyle coaching sessions)
ITM is an employer that ensures equal opportunities. Qualified applicants are encouraged to apply and will be considered during the selection process regardless of gender, age, national or ethnic origin, religion or belief, disability, sexual orientation, gender identity, or any other characteristic protected under the German General Equal Treatment Act (AGG).
If you are a qualified individual with a disability or are otherwise covered under applicable law and are unable to apply through our online application process, you may request a reasonable accommodation. Please contact career@itm-radiopharma.com.
When you apply, please let us know your earliest possible starting date and your salary expectations. You can submit your CV in German and English in docx or pdf format.
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Contact
Anastasia Dauns
career@itm-radiopharma.com
ITM Isotope Technologies Munich SE
People & Culture
Walther-von-Dyck-Str. 4
85748 Garching/München, Deutschland
Note for recruitment agencies
Please note that we do not accept unsolicited applications or offers of assistance. The telephone number given in the advertisement is intended exclusively for applicants and should not be contacted for any other purpose. Thank you very much!
More about ITM
With us, you will have the opportunity to work in an international environment on ground-breaking projects that can have a significant impact on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who share our vision and want to help shape the future of oncology. If this exciting challenge appeals to you and you would like to contribute to realising our common goal, please do not hesitate to send us your application. We look forward to hearing from you!
For more information please visit:
About ITM
ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).
We would like to fill the following permanent vacancy in hybrid working model in Garching as soon as possible
GPMO Project Manager & CMC Lead (f/m/d)
Your role
* Define and drive the program 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 and coordinate CMC activities to be scientifically robust, compliant, and inspection-ready
* Project Management expert for highly visible interdisciplinary projects
* In a function as Workteam Lead CMC for our pipeline projects you cover all CMC / IMP (Investigational Medicinal Product) topics together with your team and different stakeholders
* You will lead and coordinate your team of SMEs and connect the dots, keep the overview also in unclear situations, and continuously challenge quality, timelines and budget
* Create oversights, project and budget plans, presentations
* Trigger and facilitate steering decisions, provide with the team solutions in difficult situations, escalate deviations from the plan
* Responsible for CMC project budget, strong collaboration with finance, manage budget in SAP
* Lead necessary Tec Transfers as responsible project manager. Inhabit a strategic and cross-functional key position for the technical project management and technology transfers of e.g. R&D
* Managing the oversight and coordination of different subprojects, aligning different project plans according to resources and priority
* Work with matrix responsibility for an interdisciplinary team including Business Leadership, Quality Assurance, Quality Control, Supply Chain, Finance, IT, Validation, Manufacturing, Regulatory Affairs, Engineering and CAPEX Management
* Communicate within the project team, internal and external stakeholders, facilitate adequate project documentation, report and follow-up on project milestones, coordinate financial and resource requirements, mitigate risks and align the project team on the project goal
Your profile
* University Degree preferably in Life Science, Chemistry, Biology or Pharmacy
* Demonstrated experience in project management and leading team and deep understanding of CMC information
* Multiple years of professional GMP experience in manufacturing technology (liquids preferred), technology transfer, strategic project management and product management of a pharmaceutical, radiopharmaceutical or medical technology industry
* Further practical experience in the field manufacturing or quality control, regulatory affairs, research & development, or radiation protection advantageous
* Pragmatic, solution focused mindset and ability to clearly present information in a structured way
* Taking responsibility for milestone and budget adherence
* Flexibility, resilience, assertiveness and a high degree of organization and communication skills
* Willingness to travel internationally (max. 20%)
* Fluent in German and English, both written and spoken
Our offer
* Exciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedom
* An open working atmosphere in an international corporate culture with short communication channels
* Comprehensive onboarding programme
* Flexible working hours with home office options
* Attractive special payments
* Just a good salary? Not with us! We also offer you
o Employee participation programme
o Job bike or subsidised job ticket
o Above-average contribution to the company pension scheme
o Individually tailored further training programme (including German and English courses)
o Health promotion programmes (e.g. EGYM Wellpass, subsidy for local fitness studio, sponsorship of sporting events, various lifestyle coaching sessions)
ITM is an employer that ensures equal opportunities. Qualified applicants are encouraged to apply and will be considered during the selection process regardless of gender, age, national or ethnic origin, religion or belief, disability, sexual orientation, gender identity, or any other characteristic protected under the German General Equal Treatment Act (AGG).
If you are a qualified individual with a disability or are otherwise covered under applicable law and are unable to apply through our online application process, you may request a reasonable accommodation. Please contact career@itm-radiopharma.com.
When you apply, please let us know your earliest possible starting date and your salary expectations. You can submit your CV in German and English in docx or pdf format.
Contact
Anastasia Dauns
career@itm-radiopharma.com
ITM Isotope Technologies Munich SE
People & Culture
Walther-von-Dyck-Str. 4
85748 Garching/München, Deutschland
Note for recruitment agencies
Please note that we do not accept unsolicited applications or offers of assistance. The telephone number given in the advertisement is intended exclusively for applicants and should not be contacted for any other purpose. Thank you very much!
More about ITM
With us, you will have the opportunity to work in an international environment on ground-breaking projects that can have a significant impact on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who share our vision and want to help shape the future of oncology. If this exciting challenge appeals to you and you would like to contribute to realising our common goal, please do not hesitate to send us your application. We look forward to hearing from you!
For more information please visit: