Director of Protein & ADC Analytics | Chemist (m/w/d)

BioNTech SE

Mainz am Rhein, Rheinland-Pfalz, Deutschland
Published Dec 8, 2025
Full-time
No information

Job Summary

This Director role focuses on leading the analytical development and manufacturing activities for protein-based therapeutics and Antibody Drug Conjugates (ADCs), with a specialized focus on linker-payload analytics. The successful candidate will provide critical scientific and technical input on small molecule analytical aspects within CMC development programs, ensuring compliance with GMP standards and regulatory expectations. Day-to-day responsibilities include establishing and executing analytical control strategies, overseeing method development and validation, acting as the analytical Subject Matter Expert (SME) for regulatory filings (including CTD module 3), and managing relationships with CDMOs and external partners. This position requires a strong background (preferably a Ph.D.) in Analytical Chemistry and significant experience (at least 10 years) in a highly regulated international environment, coupled with expertise in advanced analytical techniques like HPLC, GC, and mass spectrometry.

Required Skills

Education

Master’s degree or preferably Ph.D. in Analytical Chemistry or a related field

Experience

  • At least 10 years of experience in an international, highly regulated environment
  • Proven experience in authoring CTD module 3 drug substance sections for regulatory submissions and filings
  • Experience working in intercultural and cross-functional teams
  • Strong expertise in small molecule and ADC drug linkers analytical chemistry

Languages

German (Basic)English (Fluent)

Additional

  • In-depth knowledge of standard quality processes (e.g., OOX, deviations, change controls, CAPAs)