Sr. Director, Aseptic Process & Design

Role: Senior Director overseeing aseptic process design and microbial risk management within biopharmaceutical manufacturing. Responsibilities include establishing enterprise contamination control strategies aligned with global regulatory standards (EU Annex 1, FDA guidance), developing risk assessment methodologies, authoring technical investigations, and supporting regulatory inspections. The role also entails defining standards for sterilization, media fills, and equipment design, as well as leading microbial assessments at internal sites and overseeing change controls for aseptic processes. Qualifications: Bachelor's in Microbiology, Biology, or related field; 12+ years in GMP pharmaceutical manufacturing, with 7+ years in senior leadership focused on sterility assurance, aseptic processing, and contamination control. Deep expertise in EU GMP Annex 1, FDA guidance, risk management tools, and sterilization science is required. Preferred: M.S. or Ph.D. in Microbiology or related discipline; experience with biologics or complex drug modalities. High-Value: extensive experience in aseptic process design, environmental monitoring, regulatory audits, and managing global microbial risk programs; leadership in continuous improvement initiatives; ability to influence across cross-functional teams. Work setup involves domestic and international travel (~25-35%), with a focus on global manufacturing networks.