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Associate Director, Potency Assays – AS&T Lifecycle Management
BioNTech SEAssociate Director for potency assays in BioNTech, contributing to product development and regulatory submissions. Ensuring compliance with GMP standards and leading analytical expertise in global projects.
About the role
Key responsibilities & impact- Provide technical analytical expertise in the field of potency assays for late-stage and commercial projects across a global network
- Responsible for the design and performance of method validation and transfer strategies as well as method lifecycle activities
- Participate in strategic and technical discussions within projects cross-functionally with CMC team members and external partners
- Evaluation and review of technical and regulatory submission documents in a timely manner for the approval and market launch of development products
- Act as analytical SME by providing expert knowledge for regulatory filings
Requirements
What you’ll need- An advanced university degree in a scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or a related field)
- Industry experience (5+ years) in a regulated environment in the pharmaceutical industry; managerial experience in a potency assay laboratory is considered a plus
- In-depth knowledge of cell-based and immunoassays for determining potency and biological activity
- Hands-on experience with assay development, design and performance of method validations, as well as data analysis and statistical evaluation
- Expertise in analysis of relative potency
- Experience in assay control strategies and lifecycle management of relative potency assays
- In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices
- Experience in working in intercultural, cross-functional, and global teams
- Structured way of working, ability to understand and break down complex challenges and plan associated timelines and interdependencies
- Highly motivated and willingness to work in a fast-paced and evolving environment
Benefits
Comp & perks- flexible hours
- vacation account
- Digital Learning
- Performance & talent development
- leadership development
- Apprenticeships
- LinkedIn Learning
- Company bike
- Job ticket
- Deutschlandticket
- Employer-funded pension
- Childcare
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
potency assaysmethod validationassay developmentdata analysisstatistical evaluationrelative potency analysisassay control strategieslifecycle managementcell-based assaysimmunoassays
Soft Skills
intercultural teamworkcross-functional collaborationstructured workingproblem-solvingplanningtime managementadaptabilitymotivationcommunicationleadership
Certifications
advanced university degree