BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Director AS&T Projects & Strategy - Analytical Lead(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Leading analytical activities for mAb development in biotech. Advanced scientific degree required, PhD preferred. Flexible hours, vacation account, leadership development.
Requirements
- Enthusiasm, commitment, and vision
- Advanced university degree in scientific discipline or comparable qualification
- Optional PhD or equivalent qualification
- Industry experience in biotech or pharmaceutical industry
- Strong background in analytical CMC activities for mAbs
- Work experience in mAb QC or analytical development
- Proven track record in analytical late-stage antibody development
- Experience in antibody-drug conjugates (ADCs)
- Demonstrated leadership experience
- Demonstrated analytical project management experience
- Profound knowledge of US and EU regulatory standards
- Profound knowledge of CMC analytical development packages
- Profound knowledge of Good Manufacturing Practices
- Profound knowledge of USP and Ph. Eur.
- Experience with pre-approval activities
- Fluent English
- Technical writing skills
- Experience in intercultural, cross-functional teams
- Structured way of working
- Ability to understand and break down complex challenges
- Ability to plan associated timelines and interdependencies
- High motivation
- Willingness to work in a fast-paced environment
Tasks
- Represent analytics in interdisciplinary teams
- Act as single point of contact for CMC team and stakeholders
- Manage all analytical activities
- Report status of analytical activities to stakeholders
- Coordinate analytical tasks within internal network
- Coordinate analytical tasks with external partners
- Define analytical control strategy across departments
- Align analytical control strategy with Regulatory Affairs, CMC, and Quality
- Ensure analytical strategy aligns with health authority guidelines
- Ensure analytical strategy aligns with regulatory requirements
- Author analytical CMC Module 3 package
- Review analytical CMC Module 3 package
- Manage lifecycle of analytical CMC Module 3 package
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Fluent
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital Learning
- LinkedIn Learning
Career Advancement
- Performance & 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 & 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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BIBioNTech SE
Director AS&T Projects & Strategy - Analytical Lead(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Leading analytical activities for mAb development in biotech. Advanced scientific degree required, PhD preferred. Flexible hours, vacation account, leadership development.
Requirements
- Enthusiasm, commitment, and vision
- Advanced university degree in scientific discipline or comparable qualification
- Optional PhD or equivalent qualification
- Industry experience in biotech or pharmaceutical industry
- Strong background in analytical CMC activities for mAbs
- Work experience in mAb QC or analytical development
- Proven track record in analytical late-stage antibody development
- Experience in antibody-drug conjugates (ADCs)
- Demonstrated leadership experience
- Demonstrated analytical project management experience
- Profound knowledge of US and EU regulatory standards
- Profound knowledge of CMC analytical development packages
- Profound knowledge of Good Manufacturing Practices
- Profound knowledge of USP and Ph. Eur.
- Experience with pre-approval activities
- Fluent English
- Technical writing skills
- Experience in intercultural, cross-functional teams
- Structured way of working
- Ability to understand and break down complex challenges
- Ability to plan associated timelines and interdependencies
- High motivation
- Willingness to work in a fast-paced environment
Tasks
- Represent analytics in interdisciplinary teams
- Act as single point of contact for CMC team and stakeholders
- Manage all analytical activities
- Report status of analytical activities to stakeholders
- Coordinate analytical tasks within internal network
- Coordinate analytical tasks with external partners
- Define analytical control strategy across departments
- Align analytical control strategy with Regulatory Affairs, CMC, and Quality
- Ensure analytical strategy aligns with health authority guidelines
- Ensure analytical strategy aligns with regulatory requirements
- Author analytical CMC Module 3 package
- Review analytical CMC Module 3 package
- Manage lifecycle of analytical CMC Module 3 package
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Fluent
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital Learning
- LinkedIn Learning
Career Advancement
- Performance & 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 & 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
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
Statistical Expert CMC - Analytical Development(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director Process Engineering(m/w/x)
Full-timeOn-siteSeniorMainz