BioNTech SE
Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
Full-timeOn-siteSenior
Mainz
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BI
BioNTech SEStatistical Expert CMC - Analytical Development(m/w/x)
Mainz
Full-timeOn-siteSenior
Description
You will drive product quality by applying advanced statistical models to analytical workflows, ensuring every method and regulatory filing meets the highest global standards.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Advanced degree in statistics, mathematics, or related field
- •Experience in pharma/biotech analytical development
- •Knowledge of FDA, EMA, and ICH regulations
- •Proficiency in Minitab and JMP
- •Analytical mindset and independent statistical analysis
- •Excellent communication skills in German and English
Education
Master's degree
OR
Doctoral / PhD
Tasks
- •Develop statistical guidelines for method development
- •Implement comparability studies using ICH-aligned design space approaches
- •Perform frequentist and Bayesian analyses for method validation
- •Conduct statistical assessments for stability and comparability
- •Investigate OOS and OOT results through simulations
- •Model trends and estimate shelf-life using regression
- •Prepare statistical data packages for regulatory submissions
- •Respond to regulatory queries regarding data packages
- •Provide statistical training to enhance organizational capabilities
- •Monitor advancements in the field of CMC statistics
Tools & Technologies
MinitabJMP
Languages
German – Business Fluent
English – Business Fluent
Benefits
Flexible Working
- •Flexible hours
More Vacation Days
- •Vacation account
Learning & Development
- •Digital Learning
- •LinkedIn Learning
Career Advancement
- •Performance and talent development
- •Leadership development
Other Benefits
- •Apprenticeships
- •Support for full potential
Startup Environment
- •Voice at the table
Informal Culture
- •Culture on an equal footing
Purpose-Driven Work
- •Opportunities to shape and impact
Company Bike
- •Company bike
Public Transport Subsidies
- •Job ticket
- •Deutschlandticket
Retirement Plans
- •Employer-funded pension
Childcare
- •Childcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech 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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BI
BioNTech SEStatistical Expert CMC - Analytical Development(m/w/x)
Mainz
Full-timeOn-siteSenior
New Job?Nejo!
The AI Job Search Engine
Description
You will drive product quality by applying advanced statistical models to analytical workflows, ensuring every method and regulatory filing meets the highest global standards.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Advanced degree in statistics, mathematics, or related field
- •Experience in pharma/biotech analytical development
- •Knowledge of FDA, EMA, and ICH regulations
- •Proficiency in Minitab and JMP
- •Analytical mindset and independent statistical analysis
- •Excellent communication skills in German and English
Education
Master's degree
OR
Doctoral / PhD
Tasks
- •Develop statistical guidelines for method development
- •Implement comparability studies using ICH-aligned design space approaches
- •Perform frequentist and Bayesian analyses for method validation
- •Conduct statistical assessments for stability and comparability
- •Investigate OOS and OOT results through simulations
- •Model trends and estimate shelf-life using regression
- •Prepare statistical data packages for regulatory submissions
- •Respond to regulatory queries regarding data packages
- •Provide statistical training to enhance organizational capabilities
- •Monitor advancements in the field of CMC statistics
Tools & Technologies
MinitabJMP
Languages
German – Business Fluent
English – Business Fluent
Benefits
Flexible Working
- •Flexible hours
More Vacation Days
- •Vacation account
Learning & Development
- •Digital Learning
- •LinkedIn Learning
Career Advancement
- •Performance and talent development
- •Leadership development
Other Benefits
- •Apprenticeships
- •Support for full potential
Startup Environment
- •Voice at the table
Informal Culture
- •Culture on an equal footing
Purpose-Driven Work
- •Opportunities to shape and impact
Company Bike
- •Company bike
Public Transport Subsidies
- •Job ticket
- •Deutschlandticket
Retirement Plans
- •Employer-funded pension
Childcare
- •Childcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech 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
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
- BioNTech SE
Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
Full-timeOn-siteSeniorMainz - Boehringer Ingelheim
Senior/Principal Clinical Data Scientist HTA(m/w/x)
Full-timeOn-siteSeniorIngelheim am Rhein - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Associate Director SCM Compliance(m/w/x)
Full-timeOn-siteSeniorMainz