Analytical Method Expert (Associate Director AS&T Lifecycle Management) | Pharmacist (m/w/d)

BioNTech SE

Mainz am Rhein, Rheinland-Pfalz, Deutschland
Published Jul 29, 2025
Full-time
No information

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

Not specified

Additional

  • Not specified