Analytical Method Expert (Associate Director AS&T Lifecycle Management) | Pharmacist (m/w/d)
BioNTech SE
Job Summary
As an Analytical Method Expert, you will play a pivotal role in 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 responsibilities will involve providing technical analytical expertise for late-stage and commercial projects, ensuring compliance with GMP standards, and managing method validation, transfer strategies, and lifecycle activities. You will also participate in strategic discussions with cross-functional CMC teams and external partners, and contribute expert knowledge for regulatory filings and health authority responses. This position is ideal for a highly motivated individual with a strong background in analytical chemistry and a desire to work in a fast-paced, evolving environment.
Required Skills
Education
Advanced university degree in a scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable)
Experience
- 5+ years in CMC development/commercial within the industry
- Background in organic chemistry (synthesis of small molecules and/or analytical chemistry) and/or Biologics product development
- Hands-on experience in assay development and validation, as well as data analysis and statistical evaluation
- 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
More Jobs from BioNTech SE
Associate Director, Scientific/Medical Writing | Pharmacist (m/w/d)
Nov 14, 2025
The Associate Director, Scientific/Medical Writing, based in Mainz, Germany, is responsible for the ...
Senior Scientist - RNA Mass Spectrometry | Chemist (m/w/d)
Nov 14, 2025
The Senior Scientist will join the expanding Analytical Development department in Munich-Martinsried...
Associate Director, CMC Project Management (Antibody-Drug Conjugates) | Biologist (m/w/d)
Nov 14, 2025
This pivotal Associate Director role within the CMC Project Management Team at BioNTech involves co-...