Senior Scientist, Process Development

Role: Senior Scientist I in Process Development at BioNTech, focusing on advancing antibody pipeline manufacturing. Responsibilities: develop and qualify scale-down models for monoclonal antibody downstream purification; execute process studies, optimize and characterize downstream operations—including filtration, chromatography, viral clearance—and support technology transfer and regulatory documentation. Requirements: PhD in Biomedical Engineering, Chemical Engineering, Biochemistry, or related field with 6+ years (or MS with 8+ years) industry experience in biologics process development; expertise in downstream process scale-up, process characterization, and biologics CMC processes, particularly for monoclonal antibodies or ADCs. Preferred: experience in QbD, PPQ, BLA readiness, and cross-functional technical leadership. High-value: biologics, mAbs, ADCs, downstream process development, regulatory compliance, global pharma experience, and process characterization using scale-down models. Collaboration: work within a lab-based team, cross-functional partnerships, and contribute to CMC documentation. Location: Gaithersburg, MD, onsite with domestic and international travel required.