Associate Director, Global QC Microbiology

Role: Global QC Microbiology Specialist responsible for ensuring microbial quality and contamination control across GMP biopharmaceutical production platforms. Objectives include optimizing contamination strategies, supporting regulatory compliance, and overseeing microbiology QC activities internally and externally. Core responsibilities involve managing QC operations at BioNTech labs, CDMOs, and external labs, reviewing release testing and validation documentation, authoring SOPs and standards, and implementing microbiology systems such as LIMS and eQMS. Requirements: Bachelor's in a scientific/life-science field, 7-10 years in microbiology QC within pharma, GMP and CMC experience, proficiency in regulatory interfaces, and leadership skills. Preferred skills include advanced degrees and prior leadership roles. HighValue: biologics/biopharma manufacturing, microbiology QC, GMP compliance, CDMO oversight, regulatory interaction, validation, and sterile environment management. WorkSetup: based in Gaithersburg, MD, with comprehensive benefits and a collaborative, innovation-driven environment.