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
Protein pipeline development and analytical coordination for biotech firm. 10+ years biotech/pharma experience with mAbs analytical CMC required. Flexible hours, vacation account.
Requirements
- Advanced university degree in scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable)
- Optional PhD or equivalent qualification
- 10+ years industry experience in biotech or pharmaceutical industry
- Strong background in analytical CMC activities for mAbs
- Work experience in mAb QC and/or analytical development
- Proven track record in analytical late-stage antibody development
- Ideally including 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 (PAI, BLA preparation, launch activities) is a plus
- Fluent English
- Technical writing skills
- Experience in working in intercultural, cross-functional teams
- Structured way of working
- Ability to understand and break down complex challenges
- Ability to plan associated timelines and interdependencies
- Highly motivated
- Willingness to work in a fast-paced and fast-evolving environment
Tasks
- Contribute to late-stage protein pipeline development
- Coordinate all analytical activities
- Represent analytics in interdisciplinary CMC teams
- Manage and report analytical status to stakeholders
- Coordinate tasks with internal and external partners
- Define and align analytical control strategy
- Ensure strategy compliance with health authority guidelines
- Own the analytical CMC Module 3 package
- Author, review, and manage the CMC Module 3 lifecycle
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- mAbs
- mAb QC
- antibody-drug conjugates (ADCs)
- US regulatory standards
- EU regulatory standards
- EMA
- FDA
- CMC analytical development
- Good Manufacturing Practices
- USP
- Ph. Eur.
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 your 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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BIBioNTech SE
Director AS&T Projects & Strategy - Analytical Lead(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Protein pipeline development and analytical coordination for biotech firm. 10+ years biotech/pharma experience with mAbs analytical CMC required. Flexible hours, vacation account.
Requirements
- Advanced university degree in scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable)
- Optional PhD or equivalent qualification
- 10+ years industry experience in biotech or pharmaceutical industry
- Strong background in analytical CMC activities for mAbs
- Work experience in mAb QC and/or analytical development
- Proven track record in analytical late-stage antibody development
- Ideally including 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 (PAI, BLA preparation, launch activities) is a plus
- Fluent English
- Technical writing skills
- Experience in working in intercultural, cross-functional teams
- Structured way of working
- Ability to understand and break down complex challenges
- Ability to plan associated timelines and interdependencies
- Highly motivated
- Willingness to work in a fast-paced and fast-evolving environment
Tasks
- Contribute to late-stage protein pipeline development
- Coordinate all analytical activities
- Represent analytics in interdisciplinary CMC teams
- Manage and report analytical status to stakeholders
- Coordinate tasks with internal and external partners
- Define and align analytical control strategy
- Ensure strategy compliance with health authority guidelines
- Own the analytical CMC Module 3 package
- Author, review, and manage the CMC Module 3 lifecycle
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- mAbs
- mAb QC
- antibody-drug conjugates (ADCs)
- US regulatory standards
- EU regulatory standards
- EMA
- FDA
- CMC analytical development
- Good Manufacturing Practices
- USP
- Ph. Eur.
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 your 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.
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
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
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Full-timeOn-siteSeniorMainz - BioNTech SE
Senior Manufacturing Manager Global MS&T(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Senior Scientist Manufacturing(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Senior Director Global Quality Supply(m/w/x)
Full-timeOn-siteSeniorMainz