Analytical Method Expert (Associate Director AS&T Lifecycle Management) | Pharmacist (m/w/d)
BioNTech SE
Job Summary
As an Analytical Method Expert, you will be a key contributor to the ongoing product development and regulatory submission of RNA and Protein-based therapeutic pipelines within the Analytics, Science & Technology (AS&T) department. Your day-to-day will involve acting as the primary point of contact for specific analytical methods, ensuring their compliance with GMP standards, and guaranteeing accurate, precise, and reliable results. This role offers the opportunity to provide technical analytical expertise for late-stage and commercial projects, lead method validation and transfer strategies, and participate in strategic cross-functional discussions. You will also evaluate and review technical and regulatory submission documents, acting as a Subject Matter Expert for regulatory filings and health authority inquiries. This position is ideal for a committed individual eager to work in a fast-paced environment and make a significant impact on product development and market launch.
Required Skills
Education
Advanced university degree in a scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable)
Experience
- 5+ years in CMC development/commercial
- Hands-on experience in assay development and validation
- Expertise in the definition of analytical control strategies, method validation concepts, and setting specifications for biologics and/or small molecules
- Experience in working in intercultural, cross-functional teams
Languages
Additional
- Not specified
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