Associate Director, AS&T Lifecycle Management (Biological Method Expert)

Role: Associate Director of Analytical Sciences & Technology (AS&T) Lifecycle Management, focusing on supporting the development and regulatory submission of BioNTech's protein-based therapeutics, primarily monoclonal antibodies (mAbs) and ADCs. Responsibilities: provide expert technical input on analytical methods, oversee method validation and transfer activities, review technical/regulatory documents for global submissions (BLA/MAA), and act as the analytical subject matter expert in regulatory interactions. Requirements: advanced degree in Biology, Chemistry, Pharmacy, or Biotechnology; 10+ years' experience in regulated pharmaceutical environments with deep expertise in chromatographic, spectroscopic, electrophoretic, immunoassay, and molecular biology techniques for biologics analysis; hands-on experience in assay development, validation, and data analysis; comprehensive knowledge of ICH, GMP, and industry standards; proven regulatory filing experience and interactions with health authorities. Preferred: experience managing external method validation/transfer, supporting QC investigations. HighValue: expertise in CMC activities for late-stage biologics, regulatory submission support, GMP compliance, and global cross-functional collaboration. Work setup: location in Gaithersburg, US, full-time, with a fast-paced, evolving environment.