BioNTech SE
Statistical Expert CMC - Analytical Development(m/w/x)
Full-timeOn-siteSenior
Mainz
New Job?Nejo!
The AI Job Search Engine
BIBioNTech SE
Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring GMP compliance for late-stage drug projects, developing validation and transfer strategies. Hands-on experience with HPLC, GC, mass spectrometry, NMR, and IR techniques required. Flexible hours, vacation account.
Requirements
- Advanced university degree in a scientific discipline
- Industry experience in CMC development/commercial
- Background in organic chemistry and/or Biologics product development
- In-depth knowledge of analytical techniques with hands-on experience in assay development and validation
- Experience with HPLC, GC, mass spectrometry, NMR, and IR techniques
- Experience with chromatographic, spectroscopic, electrophoretic, immunoassay and molecular biology techniques
- Experience with cell-based and immunoassays, molecular biology and physicochemical techniques
- Expertise in analytical control strategies and method validation concepts
- Experience in intercultural, cross-functional teams
- Structured way of working and ability to break down complex challenges
- Highly motivated and willingness to work in a fast-paced environment
Tasks
- Provide technical analytical expertise for late-stage and commercial projects
- Ensure compliance with GMP standards and industry guidelines
- Develop method validation and transfer strategies
- Manage method lifecycle activities, including reagent exchange and laboratory investigations
- Engage in strategic and technical discussions with CMC team members and external partners
- Evaluate and review technical and regulatory submission documents
- Act as the analytical subject matter expert for regulatory filings
- Respond to inquiries from health authorities regarding regulatory submissions
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- HPLC
- GC
- mass spectrometry
- NMR
- IR techniques
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital learning
- Apprenticeships
- LinkedIn learning
Mentorship & Coaching
- Performance & talent development
- Leadership development
- Support for your full potential
Startup Environment
- Your voice at the table
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape & 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.
Not a perfect match?
- BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
(Associate) Director Protein & ADC Drug Product(m/w/x)
Full-timeOn-siteSeniorMainz, München
BIBioNTech SE
Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring GMP compliance for late-stage drug projects, developing validation and transfer strategies. Hands-on experience with HPLC, GC, mass spectrometry, NMR, and IR techniques required. Flexible hours, vacation account.
Requirements
- Advanced university degree in a scientific discipline
- Industry experience in CMC development/commercial
- Background in organic chemistry and/or Biologics product development
- In-depth knowledge of analytical techniques with hands-on experience in assay development and validation
- Experience with HPLC, GC, mass spectrometry, NMR, and IR techniques
- Experience with chromatographic, spectroscopic, electrophoretic, immunoassay and molecular biology techniques
- Experience with cell-based and immunoassays, molecular biology and physicochemical techniques
- Expertise in analytical control strategies and method validation concepts
- Experience in intercultural, cross-functional teams
- Structured way of working and ability to break down complex challenges
- Highly motivated and willingness to work in a fast-paced environment
Tasks
- Provide technical analytical expertise for late-stage and commercial projects
- Ensure compliance with GMP standards and industry guidelines
- Develop method validation and transfer strategies
- Manage method lifecycle activities, including reagent exchange and laboratory investigations
- Engage in strategic and technical discussions with CMC team members and external partners
- Evaluate and review technical and regulatory submission documents
- Act as the analytical subject matter expert for regulatory filings
- Respond to inquiries from health authorities regarding regulatory submissions
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- HPLC
- GC
- mass spectrometry
- NMR
- IR techniques
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital learning
- Apprenticeships
- LinkedIn learning
Mentorship & Coaching
- Performance & talent development
- Leadership development
- Support for your full potential
Startup Environment
- Your voice at the table
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape & 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
Statistical Expert CMC - Analytical Development(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
(Associate) Director Protein & ADC Drug Product(m/w/x)
Full-timeOn-siteSeniorMainz, München