BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Leading late-stage technical transfer and CMC strategy for RNA and antibody-based products. Extensive late-stage product development and RNA/antibody product expertise required. Flexible hours, vacation account.
Requirements
- Advanced degree in Biotechnology, Biochemistry, Chemical Engineering, or related field
- Extensive experience in late-stage product development, commercial manufacturing, and technical lifecycle management
- Proven track record in CMC leadership, including technical transfer, regulatory submissions, and post-approval change management
- Deep understanding of RNA and antibody-based products, control strategies, and regulatory compliance
- Demonstrated ability to lead cross-functional teams and manage complex technical projects
- Excellent verbal and written communication skills
- Strong interpersonal skills and experience managing strategic partnerships with global collaborators
- Analytical mindset with a proactive approach to identifying and mitigating risks
- Experience with Biologics License Applications (BLA) and Responses to Questions (RTQs)
- Familiarity with Good Manufacturing Practices (GMP) and Annual Product Reviews (APRs)
- Expertise in managing Post-Approval Change Management Plans (PACMP)
Tasks
- Ensure compliance with regulatory dossiers
- Advocate for technical excellence
- Develop strategies for technical lifecycle management
- Lead the Commercial CMC Team
- Drive late-stage technical transfer
- Ensure Biologics License Application readiness
- Oversee Responses to Questions and launch support
- Manage GMP manufacturing investigations
- Monitor process performance and Annual Product Reviews
- Manage Post-Approval Change Management Plans
- Identify and mitigate product risks
- Drive technical improvements across the product lifecycle
- Provide guidance and training to MS&T staff
- Build strategic alliances with key partners
- Act as the primary interface for strategic partnerships
- Support product manufacturing with robust control strategies
- Lead investigations into GMP manufacturing issues
- Monitor and analyze product performance
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital learning
- Apprenticeships
- LinkedIn learning
Career Advancement
- Performance & talent development
- Leadership development
Other Benefits
- Your voice at the table
- Support for your full potential
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
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Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
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Executive Director Manufacturing Network QA(m/w/x)
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Director Process Engineering(m/w/x)
Full-timeOn-siteSeniorMainz
BIBioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Leading late-stage technical transfer and CMC strategy for RNA and antibody-based products. Extensive late-stage product development and RNA/antibody product expertise required. Flexible hours, vacation account.
Requirements
- Advanced degree in Biotechnology, Biochemistry, Chemical Engineering, or related field
- Extensive experience in late-stage product development, commercial manufacturing, and technical lifecycle management
- Proven track record in CMC leadership, including technical transfer, regulatory submissions, and post-approval change management
- Deep understanding of RNA and antibody-based products, control strategies, and regulatory compliance
- Demonstrated ability to lead cross-functional teams and manage complex technical projects
- Excellent verbal and written communication skills
- Strong interpersonal skills and experience managing strategic partnerships with global collaborators
- Analytical mindset with a proactive approach to identifying and mitigating risks
- Experience with Biologics License Applications (BLA) and Responses to Questions (RTQs)
- Familiarity with Good Manufacturing Practices (GMP) and Annual Product Reviews (APRs)
- Expertise in managing Post-Approval Change Management Plans (PACMP)
Tasks
- Ensure compliance with regulatory dossiers
- Advocate for technical excellence
- Develop strategies for technical lifecycle management
- Lead the Commercial CMC Team
- Drive late-stage technical transfer
- Ensure Biologics License Application readiness
- Oversee Responses to Questions and launch support
- Manage GMP manufacturing investigations
- Monitor process performance and Annual Product Reviews
- Manage Post-Approval Change Management Plans
- Identify and mitigate product risks
- Drive technical improvements across the product lifecycle
- Provide guidance and training to MS&T staff
- Build strategic alliances with key partners
- Act as the primary interface for strategic partnerships
- Support product manufacturing with robust control strategies
- Lead investigations into GMP manufacturing issues
- Monitor and analyze product performance
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital learning
- Apprenticeships
- LinkedIn learning
Career Advancement
- Performance & talent development
- Leadership development
Other Benefits
- Your voice at the table
- Support for your full potential
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
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director Process Engineering(m/w/x)
Full-timeOn-siteSeniorMainz