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

Role: Associate Director of Analytical Sciences & Technology (AS&T) Lifecycle Management, focusing on regulatory submission support for BioNTech's protein-based therapeutic pipeline. Responsibilities include providing technical analytical expertise for antibody projects, designing and executing method validations and transfers, participating in cross-functional scientific discussions, and reviewing technical and regulatory documentation for filings like BLA/MAA. The role involves hands-on laboratory work and acting as an SME in regulatory interactions. Requirements: advanced degree in Biology, Chemistry, Pharmacy, or Biotechnology with 10+ years in a regulated pharma environment; deep expertise in analytical methods for ADCs (e.g., drug-to-antibody ratio, residual impurities, conjugate variants), including experience with HPLC, MS, NMR, IR; proven track record in assay development, validation, and data analysis; strong knowledge of ICH, GMP, and regulatory filings (IND/IMPD, BLA/MAA). Preferred skills include managing method validation across external partners and leading QC investigations. High-value specifics: focus on ADCs, late-stage development, regulatory filings, GMP standards, and global cross-functional collaboration. Work setup: based in Gaithersburg, US, full-time, with potential for fast-paced, evolving environment engagement.