BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Associate Director Potency Assays - AS&T Lifecycle Management(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Developing and validating cell-based and immunoassays for potency in biotech product lifecycle management. 5+ years regulated industry experience required, managerial experience a plus. Flexible hours, digital learning platform.
Requirements
- Advanced university degree in scientific discipline
- 5+ years industry experience in pharmaceutical regulated environment
- Managerial experience in potency assay laboratory (plus)
- In-depth knowledge of cell-based and immunoassays for potency
- Hands-on experience with assay development and validation
- Hands-on experience with data analysis and statistical evaluation
- Expertise in analysis of relative potency
- Experience in assay control strategies and lifecycle management
- In-depth knowledge of ICH guidelines and GMP regulations
- Knowledge of industry best practices
- Experience in intercultural, cross-functional, global teams
- Structured way of working and problem-solving
- Ability to plan complex challenges and timelines
- High motivation
- Willingness to work in fast-paced environment
Tasks
- Contribute to product development and regulatory submissions
- Provide technical expertise in potency assays
- Design and perform method validation and transfer strategies
- Manage method lifecycle activities
- Participate in cross-functional strategic discussions
- Evaluate and review technical and regulatory documents
- Support regulatory filings with expert knowledge
- Respond to health authority questions and regulatory submissions
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Cell Proliferation Assays
- Cytotoxicity Assays
- ELISA
- Flow Cytometry
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
Startup Environment
- Voice at the table
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape and impact
Mentorship & Coaching
- Support for full potential
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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BIBioNTech SE
Associate Director Potency Assays - AS&T Lifecycle Management(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Developing and validating cell-based and immunoassays for potency in biotech product lifecycle management. 5+ years regulated industry experience required, managerial experience a plus. Flexible hours, digital learning platform.
Requirements
- Advanced university degree in scientific discipline
- 5+ years industry experience in pharmaceutical regulated environment
- Managerial experience in potency assay laboratory (plus)
- In-depth knowledge of cell-based and immunoassays for potency
- Hands-on experience with assay development and validation
- Hands-on experience with data analysis and statistical evaluation
- Expertise in analysis of relative potency
- Experience in assay control strategies and lifecycle management
- In-depth knowledge of ICH guidelines and GMP regulations
- Knowledge of industry best practices
- Experience in intercultural, cross-functional, global teams
- Structured way of working and problem-solving
- Ability to plan complex challenges and timelines
- High motivation
- Willingness to work in fast-paced environment
Tasks
- Contribute to product development and regulatory submissions
- Provide technical expertise in potency assays
- Design and perform method validation and transfer strategies
- Manage method lifecycle activities
- Participate in cross-functional strategic discussions
- Evaluate and review technical and regulatory documents
- Support regulatory filings with expert knowledge
- Respond to health authority questions and regulatory submissions
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Cell Proliferation Assays
- Cytotoxicity Assays
- ELISA
- Flow Cytometry
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
Startup Environment
- Voice at the table
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape and impact
Mentorship & Coaching
- Support for full potential
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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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
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Senior Manufacturing Manager Global MS&T(m/w/x)
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Senior Scientist Manufacturing(m/w/x)
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