Senior Scientist II, Analytical Development

Role Summary

Based in Gaithersburg, MD, this Senior Scientist II, Analytical Development role contributes to BioNTech's mission by leading LC-MS method development and characterization for antibody and ADC products. You will drive technical excellence and contribute to regulatory strategies and submissions to deliver high-quality therapies worldwide. In a fast-paced lab environment, you will distill complex data into actionable insights, shaping analytical strategies and ensuring regulatory compliance.

Responsibilities

• Develop and execute phase-appropriate LC-MS strategies across early and late development stages, including BLA-enabling activities
• Identify analytical risks and gaps; design mitigation plans and study strategies such as comparability, stability, characterization, and investigations
• Mentor scientists in LC-MS fundamentals, fostering scientific rigor and continuous improvement within the team
• Define and refine internal workflows and best practices for analytical development in high-impact environments
• Lead optimization and qualification of LC-MS assays across platforms (e.g., intact mass, peptide mapping, released glycan analysis)
• Implement Multi-Attribute Methods (MAM) for antibody characterization, QC support, comparability studies, and change control

Qualifications

• Required: PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with relevant post-doctoral and 8+ years industry experience; alternatively MS with substantial industry experience
• Required: Hands-on expertise in LC-MS method development, qualification/validation, transfer processes; global experience (e.g., China and/or global partners) is advantageous
• Required: Strong background in biologics CMC principles including ICH Q6b standards, PPQ/BLA readiness, analytical control strategies, and specification setting
• Required: Experience developing characterization methods for antibodies (e.g., glycans analysis) using diverse ionization modes
• Required: Proven track record as a technical leader within cross-functional teams in dynamic environments
• Required: Open-minded approach to ambiguity; ability to create structured solutions where none exist
• Preferred: 7+ years in global pharma AD and/or AS&T for monoclonal antibodies or related biologics; late-stage / BLA experience
• Preferred: Hands-on expertise in LC-MS method development, qualification/validation, transfer processes; global experience (e.g., China and/or global partners) is advantageous