BioNTech SE
Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Leading analytical project strategy for antibody development across interdisciplinary teams. 10+ years biotech/pharma industry experience, strong analytical CMC background required. Flexible hours, vacation account.
Requirements
- Advanced university degree in scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable)
- Optional PhD or equivalent qualification
- Industry experience (10+ years) within biotech or pharmaceutical industry
- Strong background in analytical CMC activities for mAbs and/or 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
- Analytical project management experience
- Profound knowledge of relevant US and EU regulatory standards
- Profound knowledge of EMA regulatory standards
- Profound knowledge of FDA regulatory standards
- Profound knowledge of CMC analytical development packages
- Profound knowledge of Good Manufacturing Practices
- Profound knowledge of USP (United States Pharmacopoeia)
- Profound knowledge of Ph. Eur. (European Pharmacopoeia)
- Experience with pre-approval activities (PAI, BLA preparation, launch activities) (plus)
- 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 fast-paced, fast-evolving environment
Tasks
- Represent analytics in interdisciplinary teams.
- Liaise with the CMC team and stakeholders.
- Manage all analytical activities successfully.
- Report progress, delays, and risks to stakeholders.
- Coordinate analytical tasks across internal and external networks.
- Ensure alignment with the overall analytical strategy.
- Define the analytical control strategy across departments.
- Align the analytical control strategy across departments.
- Ensure strategy aligns with guidelines and requirements.
- Author the analytical CMC Module 3 package.
- Review the analytical CMC Module 3 package.
- Manage the Module 3 package lifecycle.
Work Experience
10 years
Education
Master's degree
Languages
English – Business Fluent
Tools & Technologies
mAbsmAb QCADCsEMAFDAUSPPh. Eur.PAIBLA
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 full potential
Startup Environment
- •Voice at the table
Informal Culture
- •Culture on 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(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Leading analytical project strategy for antibody development across interdisciplinary teams. 10+ years biotech/pharma industry experience, strong analytical CMC background required. Flexible hours, vacation account.
Requirements
- Advanced university degree in scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable)
- Optional PhD or equivalent qualification
- Industry experience (10+ years) within biotech or pharmaceutical industry
- Strong background in analytical CMC activities for mAbs and/or 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
- Analytical project management experience
- Profound knowledge of relevant US and EU regulatory standards
- Profound knowledge of EMA regulatory standards
- Profound knowledge of FDA regulatory standards
- Profound knowledge of CMC analytical development packages
- Profound knowledge of Good Manufacturing Practices
- Profound knowledge of USP (United States Pharmacopoeia)
- Profound knowledge of Ph. Eur. (European Pharmacopoeia)
- Experience with pre-approval activities (PAI, BLA preparation, launch activities) (plus)
- 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 fast-paced, fast-evolving environment
Tasks
- Represent analytics in interdisciplinary teams.
- Liaise with the CMC team and stakeholders.
- Manage all analytical activities successfully.
- Report progress, delays, and risks to stakeholders.
- Coordinate analytical tasks across internal and external networks.
- Ensure alignment with the overall analytical strategy.
- Define the analytical control strategy across departments.
- Align the analytical control strategy across departments.
- Ensure strategy aligns with guidelines and requirements.
- Author the analytical CMC Module 3 package.
- Review the analytical CMC Module 3 package.
- Manage the Module 3 package lifecycle.
Work Experience
10 years
Education
Master's degree
Languages
English – Business Fluent
Tools & Technologies
mAbsmAb QCADCsEMAFDAUSPPh. Eur.PAIBLA
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 full potential
Startup Environment
- •Voice at the table
Informal Culture
- •Culture on 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.
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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