Immatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
Full-timeWith HomeofficeManagement
München
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ITITM Isotope Technologies Munich SE
Senior Manager, CMC Excellence & Scientific Oversight(m/w/x)
Garching bei München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading CMC pipeline projects for targeted radiopharmaceuticals, aligning with CDMOs and internal functions. Solid CMC and biologics GMP experience required. Flexible hours, home office, and employee participation programme.
Requirements
- Degree in scientific discipline (MSc or PhD preferred)
- Specialization in biologics, biotechnology, or related fields
- Experience in pharmaceutical development within GMP environment
- CDMO management experience with biologics
- Solid experience in CMC-related activities
- Exposure to radiopharmaceuticals
- Project management experience in cross-functional organizations
- Project management experience in matrix organizations
- Strong understanding of regulatory requirements
- Strong understanding of CMC documentation standards
- Familiarity with QbD principles
- Familiarity with DOE principles
- Experience with quality systems
- Experience with qualification
- Experience with validation
- Proficiency in MS Office
- Proficiency in document management systems
- SAP knowledge
- Fluent in English
Tasks
- Lead CMC-related pipeline projects
- Ensure alignment with internal functions and CDMOs
- Drive cross-functional project execution
- Own project planning, timelines, budget, resource allocation, risk management
- Develop and maintain GxP-relevant SOPs
- Ensure compliance within document management systems
- Support technology transfers to CDMOs and clinical sites
- Ensure CMC compliance and knowledge transfer
- Contribute to regulatory submissions
- Prepare CMC sections with Regulatory Affairs
- Apply and promote Quality by Design principles
- Review qualification and validation documentation
- Identify and implement process improvements
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- MS Office
- SAP
- QbD
- DOE
Benefits
Flexible Working
- Flexible working hours
- Home office options
Bonuses & Incentives
- Attractive special payments
Competitive Pay
- Employee participation programme
Company Bike
- Job bike
Public Transport Subsidies
- Subsidised job ticket
Retirement Plans
- Above-average contribution to company pension scheme
Learning & Development
- Individually tailored further training programme
- German and English courses
Healthcare & Fitness
- Health promotion programmes
- EGYM Wellpass
- Subsidy for local fitness studio
Social Impact
- Sponsorship of sporting events
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
Senior Manager, CMC Excellence & Scientific Oversight(m/w/x)
Garching bei München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading CMC pipeline projects for targeted radiopharmaceuticals, aligning with CDMOs and internal functions. Solid CMC and biologics GMP experience required. Flexible hours, home office, and employee participation programme.
Requirements
- Degree in scientific discipline (MSc or PhD preferred)
- Specialization in biologics, biotechnology, or related fields
- Experience in pharmaceutical development within GMP environment
- CDMO management experience with biologics
- Solid experience in CMC-related activities
- Exposure to radiopharmaceuticals
- Project management experience in cross-functional organizations
- Project management experience in matrix organizations
- Strong understanding of regulatory requirements
- Strong understanding of CMC documentation standards
- Familiarity with QbD principles
- Familiarity with DOE principles
- Experience with quality systems
- Experience with qualification
- Experience with validation
- Proficiency in MS Office
- Proficiency in document management systems
- SAP knowledge
- Fluent in English
Tasks
- Lead CMC-related pipeline projects
- Ensure alignment with internal functions and CDMOs
- Drive cross-functional project execution
- Own project planning, timelines, budget, resource allocation, risk management
- Develop and maintain GxP-relevant SOPs
- Ensure compliance within document management systems
- Support technology transfers to CDMOs and clinical sites
- Ensure CMC compliance and knowledge transfer
- Contribute to regulatory submissions
- Prepare CMC sections with Regulatory Affairs
- Apply and promote Quality by Design principles
- Review qualification and validation documentation
- Identify and implement process improvements
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- MS Office
- SAP
- QbD
- DOE
Benefits
Flexible Working
- Flexible working hours
- Home office options
Bonuses & Incentives
- Attractive special payments
Competitive Pay
- Employee participation programme
Company Bike
- Job bike
Public Transport Subsidies
- Subsidised job ticket
Retirement Plans
- Above-average contribution to company pension scheme
Learning & Development
- Individually tailored further training programme
- German and English courses
Healthcare & Fitness
- Health promotion programmes
- EGYM Wellpass
- Subsidy for local fitness studio
Social Impact
- Sponsorship of sporting events
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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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.
Not a perfect match?
- Immatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
Full-timeWith HomeofficeManagementMünchen - ITM Isotope Technologies Munich SE
Computerized Quality Systems & Services Manager(m/w/x)
Full-timeWith HomeofficeExperiencedGarching bei München - Immatics Biotechnologies GmbH
GCP/ GCLP Auditor as Senior Manager Clinical Quality Assurance(m/w/x)
Full-time/Part-timeWith HomeofficeSeniorTübingen, München - ITM Isotope Technologies Munich SE
Medical Affairs Manager - Publications(m/w/x)
Full-timeWith HomeofficeExperiencedGarching bei München - ITM Isotope Technologies Munich SE
Manager Production Projects(m/w/x)
Full-timeWith HomeofficeExperiencedMünchen, Neufahrn bei Freising