BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
(Associate) Director Protein & ADC Drug Product(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Leading external development and manufacturing for protein-based therapeutics at a biotech firm. Late-stage DP process development experience required; formulation or lyophilization experience preferred. Focus on external development and manufacturing partnerships.
Requirements
- Master’s degree, PhD, or comparable qualification
- Seven years of relevant professional experience
- Experience in late-stage DP process development
- Understanding of drug development stages
- Experience in formulation development or lyophilization
- Experience in clinical in-use studies
- Sound GMP knowledge
- Experience with regulatory filings for biologicals
- Leadership skills and assertiveness
- Ability to work in cross-functional teams
- Excellent communication and negotiation skills
- Ability to communicate complex technical matters
Tasks
- Lead external development and manufacturing for protein-based therapeutics
- Provide scientific input for drug product development programs
- Review and approve external regulatory development documentation
- Establish and execute drug product development strategies
- Manage technical collaborations with internal and external partners
- Create development reports and risk analysis documentation
- Oversee drug product technical transfers between manufacturing sites
- Support process scale-up to commercial GMP manufacturing
- Coordinate clinical in-use studies and pharmacy manual reviews
- Manage CMC timelines and implement proactive risk mitigation
- Drive data-driven decision making for strategic CMC discussions
- Serve as the primary contact for CDMO partners
Work Experience
- 7 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- DP process development
- GMP
- IND/IMPD
- BLA/MAA
- Lyophilization
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 Protein & ADC Drug Product(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Leading external development and manufacturing for protein-based therapeutics at a biotech firm. Late-stage DP process development experience required; formulation or lyophilization experience preferred. Focus on external development and manufacturing partnerships.
Requirements
- Master’s degree, PhD, or comparable qualification
- Seven years of relevant professional experience
- Experience in late-stage DP process development
- Understanding of drug development stages
- Experience in formulation development or lyophilization
- Experience in clinical in-use studies
- Sound GMP knowledge
- Experience with regulatory filings for biologicals
- Leadership skills and assertiveness
- Ability to work in cross-functional teams
- Excellent communication and negotiation skills
- Ability to communicate complex technical matters
Tasks
- Lead external development and manufacturing for protein-based therapeutics
- Provide scientific input for drug product development programs
- Review and approve external regulatory development documentation
- Establish and execute drug product development strategies
- Manage technical collaborations with internal and external partners
- Create development reports and risk analysis documentation
- Oversee drug product technical transfers between manufacturing sites
- Support process scale-up to commercial GMP manufacturing
- Coordinate clinical in-use studies and pharmacy manual reviews
- Manage CMC timelines and implement proactive risk mitigation
- Drive data-driven decision making for strategic CMC discussions
- Serve as the primary contact for CDMO partners
Work Experience
- 7 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- DP process development
- GMP
- IND/IMPD
- BLA/MAA
- Lyophilization
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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